Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
Phase: NA
Conditions: Glaucoma
Sponsor: MicroOptx

E arl y  BI r d 
E arl y F e asi bilit y St u d y of th e B r o wn Gl a uc o m a Im pl a nt 
i n P ati e nt s wit h S e v er e V is u al I m p airm e nt or N o Li g ht 
P e rc ei v ed   
Pr ot oc ol I d e nt if yi n g N u m b er : 4 0 3 9 
S p o ns or:  Micr o O pt x I nc 
I D E #: G 1 7 0 2 0 5 / N C T 0 3 4 6 9 2 9 7
F u n d e d b y: Micr o O pt x I nc 
V ersi o n N u m b er: v 9. 0 
J a n u ar y 2 7, 2 0 1 9 

ii 
 
Ta bl e of C o nt e nts  
LI S T O F A B B R E VI A TI O N S  ....................................................................................................................................... 1  
S p o n s or Si g n at ur e P a g e  ............................................................................................................................................ 2  
I n v e sti g at or Si g n at ur e P a g e ...................................................................................................................................... 3  
1  
P R O T O C O L S U M M A R Y  ............................................................................................................................... 4  
S C H E M A TI C O F S T U D Y D E SI G N  .......................................................................................................................... 7  
K E Y R O L E S  ................................................................................................................................................................ 8  
2  
I N T R O D U C TI O N: B A C KG R O U N D I N F O R M A TI O N A N D S CI E N TI FI C R A TI O N A L E  ........................ 1  
2. 1  
B a c k gr o u n d I nf or m ati o n  ...................................................................................................................... 1  
2. 1. 1  
Gl a u c o m a  .............................................................................................................................................. 1  
2. 1. 2  
Gl a u c o m a Tr e at m e nt s  ........................................................................................................................ 2  
2. 1. 2. 1  
M e di c al  2  
2. 1. 2. 2  
S ur gi c al  2  
2. 1. 2. 3  
MI G S  
3  
2. 1. 3  
D e vi c e D e s cri pti o n  ............................................................................................................................... 5  
2. 2  
R ati o n al e  ............................................................................................................................................... 8  
2. 3  
P ot e nti al Ri s k s a n d B e n efit s  .............................................................................................................. 9  
2. 3. 1  
K n o w n P ot e nti al Ri s k s  ..................................................................................................... 9  
2. 3. 2  
K n o w n P ot e nti al B e n efit s  .............................................................................................. 1 0  
2. 3. 3  
St u d y Ri s k Miti g ati o n  ..................................................................................................... 1 0  
2. 3. 4  
S u m m ar y of B e n efit V er s u s Ri s k  ................................................................................. 1 1  
3  
O B J E C TI V E S A N D P U R P O S E  .................................................................................................................. 1 2  
4  
S T U D Y D E SI G N A N D E N D P OI N T S  ......................................................................................................... 1 3  
4. 1  
D e s cri pti o n of t h e St u d y D e si g n  ...................................................................................................... 1 3  
4. 1. 1  
Pri m ar y E n d p oi nt  ............................................................................................................ 1 3  
4. 1. 2  
S e c o n d ar y E n d p oi nt s  .................................................................................................... 1 3  
4. 1. 3  
E x pl or at or y E n d p oi nt s  ................................................................................................... 1 4  
5  
S T U D Y E N R O L L M E N T A N D WI T H D R A W A L  ......................................................................................... 1 4  
5. 1  
P arti ci p a nt I n cl u si o n Crit eri a  ............................................................................................................ 1 4  
5. 2  
P arti ci p a nt E x cl u si o n Crit eri a  ........................................................................................................... 1 5  
5. 4  
P ati e nt E nr oll m e nt C ar d  .................................................................................................................... 1 5  
5. 5  
Str at e gi e s f or R e cr uit m e nt a n d R et e nti o n  ...................................................................................... 1 6  
5. 6  
P arti ci p a nt Wit h dr a w al or t er mi n ati o n  ............................................................................................. 1 6  
5. 6. 1  
R e a s o n s f or Wit h dr a w al or T er mi n ati o n  ..................................................................... 1 6  
5. 6. 2  
H a n dli n g of P arti ci p a nt Wit h dr a w al s or t er mi n ati o n  .................................................. 1 7  
5. 7  
Pr e m at ur e T er mi n ati o n or S u s p e n si o n of St u d y  ........................................................................... 1 7  
6  
S T U D Y D e vi c e  .............................................................................................................................................. 1 7  
6. 1  
St u d y D e vi c e D e s cri pti o n  ................................................................................................................. 1 7  
6. 1. 1  
A c q ui siti o n  ....................................................................................................................... 1 7  
6. 1. 2  
A p p e ar a n c e, P a c k a gi n g, a n d L a b eli n g  ....................................................................... 1 7  
6. 1. 3  
Pr o d u ct St or a g e a n d St a bilit y  ....................................................................................... 2 1  
6. 1. 4  
I m pl a nt pr o c e d ur e .......................................................................................................... 2 1  
6. 2  
D e vi c e di s p o siti o n Pr o c e d ur e s  ........................................................................................................ 2 3  
7  
S T U D Y P R O C E D U R E S A N D S C H E D U L E  .............................................................................................. 2 4  
7. 1  
St u d y Pr o c e d ur e s/ E v al u ati o n s  ......................................................................................................... 2 4  
7. 1. 1 St a n d ar d of c ar e st u d y pr o c e d ur e s  ...................................................................................................... 2 4  

iii 
 
7. 1. 2 St u d y s p e cifi c pr o c e d ur e s  ...................................................................................................................... 2 4  
7. 1. 3  
O p ht h al mi c E x a mi n ati o n s  ............................................................................................. 2 4  
7. 1. 3. 1  
B e st C orr e ct e d Vi s u al A c uit y  ........................................................................................ 2 5  
7. 1. 3. 2  
A p pl a n ati o n T o n o m etr y  ................................................................................................. 2 5  
7. 1. 3. 3  
B o d y T e m p er at ur e  ......................................................................................................... 2 5  
7. 1. 3. 4  
C e ntr al C or n e al T hi c k n e s s  ........................................................................................... 2 6  
7. 1. 3. 5  
G e n er al E xt er n al O h pt h al mi c e x a m  ............................................................................ 2 6  
7. 1. 3. 6  
Slit L a m p O p ht h al mi c E x a mi n ati o n s  ........................................................................... 2 7  
7. 1. 3. 7  
V erti cl e C/ D r ati o  ............................................................................................................ 3 0  
7. 1. 3. 8  
I n dir e ct O p ht h al mi c E x a mi n ati o n s ............................................................................... 3 0  
7. 1. 3. 9  
C or n e al E n d ot h eli al C ell C o u nt  .................................................................................... 3 0  
7. 1. 3. 1 0  
G o ni o s c o p y  ..................................................................................................................... 3 1  
7. 1. 3. 1 1  
O pti c N er v e I m a g e A n al y si s  ......................................................................................... 3 1  
7. 1. 3. 1 2  
P eri m etr y  ......................................................................................................................... 3 2  
7. 1. 3. 1 3  
F l u or e s c ei n St ai ni n g ...................................................................................................... 3 2  
7. 1. 3. 1 4  
S EI D E L’ S T E S TI N G  ...................................................................................................... 3 2  
7. 1. 3. 1 5  
S c hir m er T e ar T e st  ........................................................................................................ 3 4  
7. 1. 3. 1 6  
L e n s St at u s f or P h a ki c E y e s  ........................................................................................ 3 4  
7. 1. 3. 1 7  
Tr e at m e nt S ati sf a cti o n Q u e sti o n N air e  ........................................................................ 3 4  
7. 1. 3. 1 8  
S y m pt o m a n d H e alt h Pr o bl e m C h art fr o m CI G T S  .................................................... 3 4  
7. 2  
St u d y S c h e d ul e  .................................................................................................................................. 3 5  
7. 2. 1  
S cr e e ni n g/ B a s eli n e  ........................................................................................................ 3 5  
7. 2. 2  
I m pl a nt 3 6  
7. 2. 3  
F oll o w -u p  ......................................................................................................................... 3 7  
7. 2. 4  
E arl y T er mi n ati o n Vi sit  .................................................................................................. 4 2  
7. 2. 5  
S c h e d ul e of E v e nt s T a bl e  ............................................................................................. 4 3  
7. 3  
C o n c o mit a nt M e di c ati o n s, Tr e at m e nt s, a n d Pr o c e d ur e s  ............................................................. 4 5  
7. 3. 1  
Tr e at m e nt of I nf e cti o n s .................................................................................................. 4 5  
7. 3. 2  
Tr e at m e nt of H y p ot o n y  .................................................................................................. 4 6  
7. 3. 3  
M a n a g e m e nt of D e vi c e Bl o c k a g e  ................................................................................ 4 7  
7. 3. 4  
E x pl a nt ati o n of t h e Br o w n Gl a u c o m a I m pl a nt  ............................................................ 4 7  
7. 3. 5  
Pr e c a uti o n ar y M e di c ati o n s, Tr e at m e nt s, a n d Pr o c e d ur e s  ....................................... 4 8  
7. 3. 6  
Pr o hi bit e d M e di c ati o n s, Tr e at m e nt s, a n d Pr o c e d ur e s  ............................................. 4 8  
7. 3. 7  
Pr o p h yl a cti c M e di c ati o n s, Tr e at m e nt s, a n d Pr o c e d ur e s  .......................................... 4 8  
8  
A S S E S S M E N T O F S A F E T Y  ...................................................................................................................... 4 9  
8. 1  
S p e cifi c ati o n of S af et y P ar a m et er s  ................................................................................................. 4 9  
8. 1. 1  
D efi niti o n of A d v er s e E v e nt s ( A E)  ............................................................................... 4 9  
8. 1. 2  
D efi niti o n of S eri o u s A d v er s e E v e nt s ( S A E)  .............................................................. 4 9  
8. 1. 3  
A d v er s e d e vi c e eff e ct ( A D E) ........................................................................................ 5 0  
8. 1. 4  
S eri o u s a d v er s e d e vi c e eff e ct ( S A D E)  ....................................................................... 5 0  
8. 1. 5  
U n a nti ci p at e d S eri o u s a d v er s e d e vi c e eff e ct ( U S A D E)  ........................................... 5 0  
8. 1. 6  
Pr e -s p e cif i e d li st of a d v er s e e v e nt s ............................................................................. 5 0  
8. 2  
Cl a s sifi c ati o n of a n A d v er s e E v e nt  ................................................................................................. 5 1  
8. 2. 1  
R el ati o n s hi p t o D e vi c e or Pr o c e d ur e —  C a u s alit y  .................................................... 5 1  
8. 3  
Ti m e P eri o d a n d Fr e q u e n c y f or E v e nt A s s e s s m e nt a n d F oll o w -U p  .......................................... 5 5  

i v 
 
8. 4  
R e p orti n g Pr o c e d ur e s  ....................................................................................................................... 5 5  
8. 4. 1  
A d v er s e E v e nt R e p orti n g  .............................................................................................. 5 5  
8. 4. 2  
S eri o u s A d v er s e E v e nt R e p orti n g  ............................................................................... 5 5  
8. 5  
D e vi c e D efi ci e n ci e s  ........................................................................................................................... 5 5  
8. 6  
S u bj e ct D e at h  ..................................................................................................................................... 5 6  
8. 7  
St u d y H alti n g R ul e s  ........................................................................................................................... 5 7  
8. 8  
S af et y O v er si g ht  ................................................................................................................................ 5 7  
9  
C L I NIC A L  M O N IT O R IN G  ............................................................................................................................ 5 8  
1 0  
S T A TI S TI C A L C O N SI D E R A TI O N S  .......................................................................................................... 5 8  
1 0. 1  
St ati sti c al a n d A n al yti c al Pl a n s  ........................................................................................................ 5 8  
1 0. 2  
St ati sti c al H y p ot h e s e s  ....................................................................................................................... 5 8  
1 0. 3  
A n al y si s D at a s et s  .............................................................................................................................. 5 9  
1 0. 4  
D e s cri pti o n of St ati sti c al M et h o d s  ................................................................................................... 5 9  
1 0. 4. 1  
G e n er al A p pr o a c h  .......................................................................................................... 5 9  
1 0. 4. 2  
A n al y si s of t h e Pri m ar y Effi c a c y E n d p oi nt( s)  ............................................................. 5 9  
1 0. 4. 3  
A n al y si s of t h e S e c o n d ar y E n d p oi nt( s)  ....................................................................... 6 0  
1 0. 4. 4  
S af et y A n al y s e s  .............................................................................................................. 6 0  
1 0. 4. 5  
B a s eli n e D e s cri pti v e St ati sti c s  ..................................................................................... 6 0  
1 0. 4. 6  
Pl a n n e d I nt eri m A n al y s e s  ............................................................................................. 6 0  
1 0. 4. 7  
A d diti o n al S u b -Gr o u p A n al y s e s  ................................................................................... 6 0  
1 0. 4. 8  
M ulti pl e C o m p ari s o n/ M ulti pli cit y ................................................................................... 6 0  
1 0. 4. 9  
T a b ul ati o n of I n di vi d u al R e s p o n s e D at a  ..................................................................... 6 0  
1 0. 4. 1 0  
E x pl or at or y A n al y s e s  ..................................................................................................... 6 0  
1 0. 5  
S a m pl e Si z e  ....................................................................................................................................... 6 1  
1 0. 6  
M e a s ur e s t o Mi ni mi z e Bi a s  .............................................................................................................. 6 1  
1 0. 6. 1  
E nr oll m e nt/ R a n d o mi z ati o n/ M a s ki n g Pr o c e d ur e s  .................................................... 6 1  
1 1  
S O U R C E D O C U M E N T S A N D A C C E S S T O S O U R C E D A T A/ D O C U M E N T S  ................................... 6 1  
1 2  
E T HI C S/ P R O T E C TI O N O F H U M A N S U B J E C T S  ................................................................................... 6 2  
1 2. 1  
I n stit uti o n al R e vi e w B o ar d (I R B) ..................................................................................................... 6 2  
1 2. 2  
Et hi c al St a n d ar d –  St at e m e nt s of c o m pli a n c e  .............................................................................. 6 2  
1 2. 3  
I nf or m e d C o n s e nt Pr o c e s s ............................................................................................................... 6 2  
1 2. 3. 1  
C o n s e nt/ a s s e nt a n d Ot h er I nf or m ati o n al D o c u m e nt s Pr o vi d e d t o P arti ci p a nt s .... 6 3  
1 2. 3. 2  
C o n s e nt Pr o c e d ur e s a n d D o c u m e nt ati o n  .................................................................. 6 3  
1 2. 4  
P arti ci p a nt a n d d at a C o nfi d e nti alit y  ................................................................................................ 6 3  
1 2. 4. 1  
R e s e ar c h U s e of St or e d H u m a n S a m pl e s, S p e ci m e n s or D at a  .............................. 6 4  
1 2. 5  
F ut ur e U s e of St or e d S p e ci m e n s  .................................................................................................... 6 4  
1 3  
D A T A H A N D LI N G A N D R E C O R D K E E PI N G  .......................................................................................... 6 4  
1 3. 1  
D at a C oll e cti o n a n d M a n a g e m e nt R e s p o n si biliti e s  ...................................................................... 6 4  
1 3. 2  
St u d y R e c or d s R et e nti o n  .................................................................................................................. 6 4  
1 3. 3  
Pr ot o c ol D e vi ati o n s ............................................................................................................................ 6 5  
1 3. 4  
P u bli c ati o n a n d D at a S h ari n g P oli c y  ............................................................................................... 6 6  
1 4  
S T U D Y A D MI NI S T R A TI O N  ........................................................................................................................ 6 7  
1 4. 1  
S p o n s or i nf or m ati o n  .......................................................................................................................... 6 7  
1 7  
LI T E R A T U R E R E F E R E N C E S .................................................................................................................... 6 8  
A P P E N DI X  ................................................................................................................................................................. 7 2  
 

v  
 
T a bl e of   Fi g ur es  
Fi g ur e 1:  a b e xt er n o a n d a b i nt er n o a p pr o a c h  ..................................................................................... 3  
Fi g ur e 2: S urf a c e di m e n si o n s of t h e Br o w n Gl a u c o m a I m pl a nt ( B GI)  ............................................... 6  
Fi g ur e 3: L a mi n ar t hi c k n e s s of t h e B GI  .................................................................................................. 6  
Fi g ur e 4: E n d o n vi e w of t h e B GI  ............................................................................................................. 6  
Fi g ur e 5: B GI at 3 m o nt h s p o st -i m pl a nt .................................................................................................. 8  
Fi g ur e 6: P ati e nt C ar d  ............................................................................................................................. 1 6  
Fi g ur e 7: B GI  ............................................................................................................................................. 1 8  
Fi g ur e 8: C a p p e d T u b e P a c k a g e  ........................................................................................................... 1 8  
Fi g ur e 9: D o u bl e -b a g g e d T y v e k P o u c h e s  ............................................................................................ 1 9  
Fi g ur e 1 0: L a b el s  ...................................................................................................................................... 2 0  
Fi g ur e 1 1 I m pl a nt e d P orti o n  ................................................................................................................... 2 3  
Fi g ur e 1 2 C or n e al Fl u or e s c ei n S c ori n g  ................................................................................................ 3 2  
Fi g ur e 1 3: Fl u or e s c ei n a p pli c at or  .......................................................................................................... 3 3  
Fi g ur e 1 4: P o siti v e S ei d el' s T e st  ............................................................................................................ 3 3  
 
T A B L E O F T A B L E S  
T a bl e 1 M o difi e d L O C S S c ori n g  ............................................................................................................ 2 8  
T a bl e 2 J a b U v eiti s S c ori n g  .................................................................................................................... 2 9  
T a bl e 3 S c h e d ul e of E v e nt s  .................................................................................................................... 4 3  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1  
LI S T O F A B B R E VI A TI O N S  
A D E  
A d v ers e D evic e Eff ect  
A E  
A d v ers e E v e nt  
A H  
A q u e o us H u m or  
AL T  
Ar g o n L as er T r a b ec ul o pl asty 
A N SI  
A m eric a n N ati o n al St a n d ar ds I nstit ut e  
B GI  
Br o w n Gl a uc o m a I m pl a nt  
C F R  
C o d e of F e d er al R e g ul ati o ns  
C R F  
C as e R e p ort F or m  
C S  
Cli nic all y Si g nific a nt  
D S M B  
D at a S af ety M o nit ori n g B o ar d  
E C  
Et hics C o m mitt e e  
E C P  
E n d osc o pic C ycl o p h ot oc o a g ul a ti o n 
e C R F  
El ectr o nic C as e R e p ort F or m  
E D C  
El ectr o nic D at a C a pt ur e  
E T D R S  
E arl y Tr e at m e nt Di a b etic R eti n o p at h y St u d y  
F D A  
F o o d a n d Dr u g A d mi nistr ati o n  
H V F  
H u m p hr ey Vis u al Fi el d  
I F U 
I nstr ucti o ns f or Us e 
I O P 
I ntr a oc ul ar Pr ess ur e 
I R B 
I nstit uti o n al R evi e w B o ar d 
I S O 
I nt er n ati o n al Or g a niz ati o n f or St a n d ar diz ati o n 
L o g M A R 
L o g arit h m of t h e M i ni m u m A n gl e of R es ol uti o n  
MI G S  
Mi ni m all y I n v asi v e Gl a uc o m a S ur gic al  
m m  
Milli m et ers  
m m H g  
Milli m et ers of M erc ur y  
N C S  
N ot Cli nic all y Si g nific a nt  
NL P  
N o Li g ht P erc e pti o n  
N S AI D  
N o nst er oi d al A nti -I nfl a m m at or y A g e nt 
O C T  
O ptic al C o h er e nc e T o m o gr a p h y  
O S D  
Oc ul ar S urf ac e Dis e as es  
P E G  
P ol y et h yl e n e Gl yc ol  
PI  
Pri nci p al I n v esti g at or 
P G V A  
Pr es e nt Gl ass es Vis u al Ac uity  
r N FL 
R eti n al N er v e Fi b er L a y er  
S A D E  
S eri o us A d v ers e D evic e Eff ect  
S A E  
S eri o us A d v ers e E v e nt  
SI T A  
S w e dis h I nt er acti v e T hr es h ol di n g Al g orit h m  
SL T  
s el ecti v e L as er Tr a b ec ul o pl asty 
T A S S  
T oxic A nt eri or S e g m e nt S y n dr o m e  
T S Q  
Tr e at m e nt S atisf acti o n Q u esti o n n air e  
U A D E  
U n a ntici p at e d A d v ers e D evic e Eff ect  
U C V A  
U nc orr ect e d Vis u al Ac uity  
µ m  
Micr o m et er  
U S  
U nit e d St at es  
U S A D E  
U n a ntici p at e d S eri o us A d v ers e D evic e Eff ect  
 
 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2  
S P O N S O R  SI G N A T U R E P A G E  
 
  
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3  
I N V E S TI G A T O R SI G N A T U R E P A G E  
I n v esti g at or Ac k n o wl e d g e m e nt Si g n at ur e:  
  
I h a v e r ec eiv e d a n d r evi e w e d t his Cli nic al I nv esti g ati o n al Pl a n. I will c o n d uct t h e Tri al as d escri b e d.  
  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 _ _ _ _ _ _ _ _ _ _ _   
I nv esti g at or’s N a m e ( pri nt)  
 
 
 
Sit e N u m b er  
  
  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 _ _ _ _ _ _ _ _ _ _ _  
 Inv esti g at or ’s Si g n at ur e  
 
 
 
D at e  
  
 
 
 
 
 
 
 
 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4  
 
 
1  
P R O T O C O L S U M M A R Y  
Titl e:  
E arl y BI r d: E arly F e asi bilit y St u dy of t h e Br o w n Gl a uc o m a I m pl a nt i n 
P ati e nts wit h S ev er e Vis u al I m p air m e nt or N o Li g ht P erc e pti o n a n d 
El e v at e d I ntr a oc ul ar Pr ess ur e  
St u d y P ur p os e : 
T o ass ess t h e  s af ety a n d f e asi bilit y of l o w eri n g i ntr a oc ul ar pr ess ur e wit h 
t h e Br o w n Gl a uc o m a I m pl a nt. 
St u d y D esi g n : 
Pr os p ectiv e, n o n -r a n d o miz e d, si n gl e-ar m, m ulti -c e nt er ( 3), e arly f e asi bilit y  
st u dy. 
D escri pti o n of St u d y  
D e vic e  : 
T h e Br o w n Gl a uc o m a I m pl a nt ( B GI) is a n i m pl a nt a bl e d e vic e d esi g n e d t o 
l o w er i ntr a oc ul ar pr ess ur e (I O P) i n gl a uc o m a p ati e nts by s h u nti n g a q u e o us 
h u m or fr o m t h e a nt eri or c h a m b er of t h e ey e t o t h e s urf ac e of t h e ey e. 
B ec a us e t h er e ar e n o p hysi ol o gic s o urc es o f o utfl o w r esist a nc e, t h e d e vic e 
c a n b e e n gi n e er e d t o t ar g et a n I O P t h at is l o w e n o u g h t o h alt t h e 
pr o gr essi o n t o bli n d n ess  i n a p ati e nt s uff eri n g fr o m gl a uc o m a.   
Eli gi bilit y Crit eri a : 
I ncl usi o n Crit eri a 
1.  A g e 2 2 y e ars a n d ol d er . 
2.  B est c orr ect e d vis u al ac uit y of 2 0/ 4 0 0 or w ors e. i n t h e st u dy ey e. 
3.  F ell o w e y e wit h vis u ally ac uit y of 2 0/ 2 0 0 or b ett er a n d t h e vis u al fi el d 
n o w ors e t h a n t h e st u dy ey e.  If t h e st u dy ey e h as n o li g ht p erc e pti o n, 
t h e f ell o w e y e m a y h a v e n o li g ht p erc e pti o n or b ett er.  
 
4.  Intr a oc ul ar  pr ess ur e  i n t h e st u dy ey e gr e at er t h a n  or e q u al t o 2 1  
m m H g a n d l ess t h a n or e q u al t o 5 0  m m H g . 
5.  Pri m ar y o p e n -a n gl e gl a uc o m a (c o nfir m e d by g o ni osc o py).  
6.  Gl a uc o m at o us o ptic n er v e d a m a g e as evi d e nc e d b y a ny of t h e 
f oll o wi n g o ptic disc or r eti n al n er v e fi b er l ay er str uct ur al 
a b n or m aliti es:  
( 1) Diff us e t hi n ni n g, f oc al n arr o wi n g, or n otc hi n g of t h e o ptic disc ri m, 
es p eci ally at t h e i nf eri or or s u p eri or p ol es w it h or wit h o ut disc 
h e m orr h a g e;  
( 2) L oc aliz e d a b n or m aliti es of t h e p eri p a pill ary r eti n al n er v e fi b er 
l a y er, es p eci ally at t h e i nf eri or or s u p eri or p ol es; or  
( 3) O ptic disc n e ur al ri m asy m m etr y of t h e t w o ey es c o nsist e nt wit h 
l oss of n e ur al tiss u e 
7.  H u m p hr e y Vis u al Fi el d  ( H VF) d e m o nstr ati ng vis u al fi el d d ef ects 
c o nsist e nt wit h gl a uc o m at o us o ptic n erv e d a m a g e:  
F or m o d er at e gl a uc o m at o us l oss  
 - M e a nt d evi ati o n >  -6 a n d  <  -1 2 d B  
 - F e w er t h a n 3 7 p oi nts d e pr ess e d b el o w t h e 5 % pr o b a bilit y 
l e v el a n d f e w er t h a n 2 0 p oi nts b el o w t h e p < 1 % l e v el 
 - N o a bs ol ut e d eficit i n t h e c e ntr al 5 d e gr e es  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5  
 - O nly o n e h e mifi el d wit h s e nsiti vity of < 1 5 d B i n t h e 5 c e ntr al 
d e gr e es  
F or a d v a nc e d Gl a uc o m at o us l oss  
- 
M D > -1 2 d B  
- 
M or e t h a n 3 7 p oi nts d e pr ess e d b el o w t h e 5 % pr o b a bilit y 
l e v el a n d m or e t h a n 2 0 p oi nts b el o w t h e p < 1 % l e v el  
- 
A bs ol ut e d eficit i n t h e c e ntr al 5 d e gr e es  
- 
S e nsiti vity < 1 5 d B i n t h e 5 c e ntr al d e gr e es i n b ot h 
h e mifi el ds  
8.  At l e ast t w o c o nti g u o us cl oc k h o urs of i nt act c o nj u nctiv a n e ar t h e 
li m b us b et w e e n cl oc k h o urs of 9 : 0 0 a n d 0 3: 0 0  i n t h e st u dy ey e. 
9.  A d e q u at e s p ac e i n t h e a nt eri or c h a m b er  of t h e st u dy ey e  s uffici e nt t o 
s u p p ort i m pl a nt wit h t h e B GI, d efi n e d as t w o c o nti g u o us cl ock h o urs 
of scl er al s p ur vis u aliz ati o n vi a g oi ni osc o py, wit h o ut c o m pr essi o n, i n 
t h e s u p eri or 1 8 0 d e gr e es of t h e a nt eri or a n gl e.  
1 0.  A bl e a n d willi n g t o c o m pl y wit h pr ot oc ol r e q uir e m e nts . 
1 1.  A bl e t o u n d erst a n d a n d si g n t h e I nf or m e d C o ns e nt f or m.  
E xcl usi o n Crit eri a  
1.  Acti v e N e o v asc ul ar Gl a uc o m a  i n t h e st u dy ey e. 
2.  Pi g m e nt ar y Gl a uc o m a i n t h e st u dy e y e.  
3.  Ps e u d o exf oli ativ e Gl a uc o m a i n t h e st u dy e y e.  
4.  C or n e al c o n diti o ns i n t h e st u dy e y e t h at m a y i n hi bit n or m al 
i ncisi o n al h e ali n g ( e. g. F uc h’s dystr o p hy) or i m p air vis u aliz ati o n of 
t h e i m pl a nt i nsi d e t h e a nt eri or c h a m b er.   
5.  A ntici p at e d n e e d f or oc ul ar s ur g er y  wit hi n o n e y e ar i n t h e st u dy 
e y e .  
6.  R e q uir e m e nt of a c o m bi n e d gl a uc o m a pr oc e d ur e i n t h e st u dy e y e.  
7.  C o nt act l e ns  us e i n t h e st u dy ey e . 
8.  Cli nic ally si g nific a nt i nfl a m m ati o n or i nf ecti o n i n t h e st u dy ey e 
wit hi n 6 0 d a ys pri or t o t h e pr e o p er ati v e visit ( e. g., bl e p h aritis, 
c o nj u nctivitis, k er atitis, uv eitis, h er p es si m pl ex i nf ecti o n) or a ny 
s yst e mic i nf ecti o n. F or p ur p os es of t his st u dy, cli nic ally si g nific a nt 
is c o nsi d er e d a n y s uc h c o n diti o n r e q uiri n g pr escri pti o n t h er a py.  
9.  Ot h er cli nic al c o n diti o ns:  
a.  P o orl y c o ntr oll e d di a b et es ( T y p e I or Ty p e II) as 
d et er mi n e d b y H b A 1c > 8 . 
b.  C a nc er r e q uiri n g tr e at m e nt d uri n g t h e d ur ati o n of t h e 
st u dy. 
c. A ny d r u gs ( e. g.: i m m u n os u p pr essi v e dr u gs) or c o-
m or bi dity t h at mi g ht i n hi bit w o u n d h e ali n g .  
1 0.  P artici p ati o n i n a ny ot h er cli nic al tri al d uri n g p artici p ati o n i n t his 
tri al. 
1 1.  Lif e ex p ect a nc y < 1 y e ar. 
 
If b ot h ey es of a pr os p ecti v e tri al p artici p a nt ar e eli gi bl e, o nly t h e ey e wit h 
t h e hi g h est i ntr a oc ul ar pr ess ur e will b e s el ect e d f or i m pl a nt. 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6  
W as h o ut p eri o d:  
T h er e will b e n o w as h o ut p eri o d of I O P -l o w eri n g m e dic ati o ns. R at h er, all 
m e dic ati o ns f or tr e at m e nt of gl a uc o m a will b e st a biliz e d 3 0 d a ys pri or t o 
t h e I m pl a nt visit.   
N u m b er of Sit es 
e nr olli n g p artici p a nts : 
T hr e e  sit es i n t h e U nit e d St at es of A m eric a. 
St u d y Siz e:  
1 0  s u bj ects. 
Pri m ar y Eff ecti v e n ess  
E n d p oi nt : 
O v er all r es p o n d er r at e, wit h r es p o n d er d efi n e d as ac hi e vi n g at l e ast 2 0 % 
r e d ucti o n fr o m b as eli n e i n IO P .  
S ec o n d ar y Eff ecti v e n ess  
E n d p oi nts : 
•  
M e a n c h a n g e fr o m b as eli n e i n I O P  
•  
R es p o n d er r at e, wit h r es p o n d er d efi n e d as ac hi evi n g f oll o w -u p 
I O P l ess t h a n or e q u al t o 1 4  m m H g  
•  
C h a n g e i n I O P -l o w eri n g m e dic ati o ns 
E x pl or at or y E n d p oi nts : 
•  
C h a n g es fr o m b as eli n e i n t h e Sc hir m er T e ar T est  
•  
Tr e at m e nt s atisf acti o n q u esti o n n air e at six m o nt hs p ost i m pl a nt 
( T S Q) 
S af et y E n d p oi nt : 
R at e of all A Es, A D Es, S A Es, S A D Es a n d U A D Es  t hr o u g h t h e six m o nt hs p ost-
i m pl a nt visit, wit h c o nti n ui n g f oll o w u p of A D Es, S A Es, S A D Es a n d U A D Es 
t hr o u g h o ut t h e st u dy. 
St u d y Sc h e d ul e : 
•  
Scr e e ni n g v isit w hic h i ncl u d es I nf or m e d C o ns e nt , eli gi bilit y, a n d 
b as eli n e d at a c oll ecti o n  
•  
I m pl a nt visit wit h s ur gic al i m pl a ntati o n of B GI  wit hi n 4 2  d ays of 
scr e e ni n g; m ay b e s a m e d ay as b as eli n e d at a c oll ecti o n  
•  
O n e d a y p ost -i m pl a nt 
•  
O n e w e e k visit: 5 -9 d a ys p ost -i m pl a nt 
•  
T w o w e e k visit: 1 1 -1 7 d a ys p ost -i m pl a nt 
•  
1 m o nt h visit: 2 5 -3 5 d a ys p ost -i m pl a nt 
•  
2 m o nt h visit: 5 0 -7 0 d a ys p ost -i m pl a nt 
•  
3 m o nt h visit: 7 5 -1 0 5 d a ys p ost -i m pl a nt 
•  
4. 5 m o nt h visit: 1 2 5 -1 5 0 d ays p ost -i m pl a nt 
•  
6 m o nt h visit: 1 6 8 -1 9 6 d a ys p ost -i m pl a nt –  Pri m ary E n d P oi nt 
e v al u ati o n  
•  
8 m o nt h visit:  2 2 5 -2 5 5 d a ys p ost -i m pl a nt 
•  
1 0 m o nt h visit: 2 8 5 -3 1 5 d ays p ost i m pl a nt  
•  
1 2 m o nt h visit: 3 3 0 -3 9 0   d ays p ost -i m pl a nt 
•  
1 5 m o nt h visit:  4 4 0 -4 7 0 d ays p ost i m pl a nt  
•  
1 8 m o nt h visit: 5 3 0 -5 6 0  d ays p ost i m pl a nt  
•  
2 1 m o nt h visit: 6 2 0 -6 5 0 d ays p ost i m pl a nt  
•  
2 4 m o nt h visit: 6 9 0 –  7 5 0 d a ys p ost -i m pl a nt 
St u d y D ur ati o n : 
Pri m ar y e n d p oi nts will b e ev al u at e d at six m o nt hs, a n d all s u bj ects will b e 
f oll o w e d t hr o u g h 2 4 m o nt hs p ost -i m pl a nt. Ex p ect e d s u bj ect accr u al is o n e 
t o t hr e e m o nt hs. 
P artici p a n t D ur ati o n: 
2 4 m o nt hs , t h o u g h st u dy su bj ects m a y b e e nr oll e d i n a l o n g -t er m f oll o w-
u p r e gistr y aft er t h e 2 4 m o nt h visit .  
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
7  
 
S C H E M A TI C O F S T U D Y D E SI G N  
 
 
Scr e e ni n g
• D a y -4 2 t o -1
E nr oll m e nt/I m pl a nt
• D ay 0
F oll o w -u p/ w o u n d c h eck
• D ay 1
• W e e k 1 ( 5 - 9 d ays p ost -i m pl a nt)
• W e e k 2 ( 1 1 - 1 7 d ays)
• M o nt h 1 ( 2 5 - 3 5 d ays)
• M o nt h 2 ( 5 0 - 7 0 d ays)
• M o nt h 4. 5 ( 1 2 5 -1 5 0 d ays)
• M o nt h 3 ( 7 5 -1 0 5 d ays)
Pri m ar y E n d p oi nt Ev al u ati o n
• M o nt h 6 ( 1 6 8 -1 9 6 d a ys p ost -i m pl a nt)
L o n g Ter m F oll o w-u p Ev al u ati o n
• M o nt h 8 ( 2 2 5 -2 5 5 d a ys p ost -i m pl a nt)
• M o nt h 1 0 ( 2 8 5 -3 1 5 d a ys)
• M o nt h 1 2 ( 3 3 0 -3 9 0 d a ys)
• M o nt h 1 5 ( 4 4 0 -4 7 0 d a ys)
• M o nt h 1 8 ( 5 3 0 -5 6 0 d a ys)
• M o nt h 2 1 ( 6 2 0 -6 5 0 d a ys)
• M o nt h 2 4 ( 6 9 0 -7 5 0 d a ys)

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1  
Cli nic al St u d y M a n a g er/ M o nit or : 
 
 
 
 
 
 
 
T h e M e dic al Dir ect or will r e vi e w all S eri o us A dv ers e Ev e nts wit hi n o n e w e e k of b ei n g r e p ort e d, a n d will 
r e vi e w all a dv ers e e v e nts ev ery t w o m o nt hs. 
 
2   
I N T R O D U C TI O N: B A C K GR O U N D I N F O R M A TI O N A N D S CI E N TI FI C R A TI O N A L E  
 
2. 1  
B A C K G R O U N D I N F O R M A TI O N  
2. 1. 1  G L A U C O M A  
Gl a uc o m a is t h e l e a di n g c a us e of irr ev ersi bl e bli n d n ess w orl d wi d e, afflicti n g u p t o 1 0 5 milli o n p e o pl e 
–  t h e W orl d Gl a uc o m a C o n gr ess ex p ects t his n u m b er t o d o u bl e i n t h e n ext 2 0 y e ars d u e t o a n a gi n g 
p o p ul ati o n. Av ail a bl e tr e at m e nts –  m e dic ati o ns, s ur g eri e s, l as ers a n d i m pl a nt a bl e d e vic es –  ar e 
ex p e nsi v e a n d h av e b e e n s h o w n t o, at b est, o nl y m a n a g e t his r el e ntl essl y pr o gr essi v e c o n diti o n. 
D es pit e t h e c o ns e q u e nc es a n d ec o n o mic b ur d e n ass oci at e d wit h u ntr e at e d gl a uc o m a, t h e W orl d 
H e alt h Or g a niz ati o n h as eli mi n at e d r o uti n e scr e e ni n g d u e t o t h e l ac k of u ni v ers all y acc e pt e d as s af e 
a n d eff ectiv e t h er a pi es. Gl a uc o m a r e pr es e nts a m aj or w orl d -wi d e u n m et n e e d.  
D a m a g e t o t h e o ptic n er v e c a us e d b y gl a uc o m a m ay c a us e p er m a n e nt visi o n l oss. T h e m ost  
c o m m o n c a us e of d a m a g e t o t h e o ptic n er v e is exc essi v e i ntr a oc ul ar fl ui d a n d r es ult a nt el ev at e d 
i ntr a oc ul ar pr ess ur e (I O P). T h e i ncr e as e d i ntr a oc ul ar fl ui d pr ess ur e r es ults fr o m a v ari ety of c a us es, 
i ncl u di n g bl oc k a g e of dr ai n a g e d ucts a n d n arr o wi n g or clos ur e of t h e dr ai n a g e a n gl e b et w e e n t h e iris 
a n d c or n e a.  
T h e pri m ar y t y p es of gl a uc o m a i ncl u d e o p e n -a n gl e a n d cl os e d a n gl e gl a uc o m a. O p e n a n gl e r ef ers t o 
t h e i ntr a oc ul ar dr ai n a g e a n gl e b et w e e n t h e iris a n d c or n e a b ei n g as wi d e o p e n as it s h o ul d b e. O p e n 
a n gl e gl a uc o m a f e at ur es sl o w cl o g gi n g of t h e dr ai n a g e c a n als i n t h e dr ai n a g e a n gl e a n d r es ults i n 
i ncr e as e d i ntr a oc ul ar pr ess ur e a n d pr o gr essi v e o ptic n er v e d a m a g e. I n o p e n/ wi d e-a n gl e gl a uc o m a, 
fl o w is r e d uc e d t hr o u g h t h e tr a b ec ul ar m es h w or k d u e t o t h e d e g e ner ati o n a n d o bstr ucti o n of t h e 
tr a b ec ul ar m es h w ork, w h os e ori gi n al f u ncti o n is t o a bs or b t h e a q u e o us h u m or. L oss of a q u e o us 
h u m or a bs or pti o n l e a ds t o i ncr e as e d r esist a nc e a n d t h us a c hr o nic, p ai nl ess b uil d u p of pr ess ur e i n 
t h e ey e. T his is t h e m ost c o m m o n t y p e of gl a uc o m a, acc o u nti n g f or 9 0 % of c as es i n t h e U nit e d 
St at es, b ut f e w er i n Asi a n c o u ntri es.   It is t his pri m ar y o p e n-a n gl e gl a uc o m a t h at t h e Micr o O ptx 
t ec h n ol o gy will i niti ally a d dr ess.   

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2  
2. 1. 2   G L A U C O M A T R E A T M E N T S  
T h e m o d er n g o al of gl a uc o m a m a n a g e m e nt is t o av oi d n er v e d a m a g e, a n d t h us pr es er v e si g ht. 
Alt h o u g h i ntr a oc ul ar pr ess ur e is o nl y o n e of t h e m aj or ris k f act ors f or gl a uc o m a, l o w eri n g it vi a 
v ari o us p h ar m ac e utic als a n d/ or s ur gic al t ec h ni q u es is c urr e ntl y t h e m ai nst ay of gl a uc o m a 
tr e at m e nt. 
2. 1 . 2. 1 
M E DI C A L  
M e dic al m a n a g e m e nt is t h e m ost c o m m o n tr e at m e nt f or gl a uc o m a. I ntr a oc ul ar pr ess ur e c a n b e 
l o w er e d, at l e ast f or a ti m e, wit h m e dic ati o ns - us u ally e y e dr o ps. S e v er al cl ass es of m e dic ati o ns 
ar e us e d t o tr e at gl a uc o m a, wit h s e v er al m e dic ati o ns i n e ac h cl ass. T h es e m e dici n es m a y h av e l oc al 
a n d s yst e mic si d e eff ects. A d h er e nc e t o a m e dic ati o n pr ot oc ol c a n b e c o nf usi n g a n d ex p e nsiv e; if 
si d e eff ects occ ur, t h e p ati e nt m ust b e willi n g eit h er t o t ol er at e t h e m, or t o c o m m u nic at e wit h t h e 
tr e ati n g p hysici a n t o i m pr ov e t h e dr u g r e gi m e n. P o or c o m pli a nc e wit h m e dic ati o ns a n d f oll o w-u p 
visits is a m aj or c o nc er n i n gl a uc o m a p ati e nts. T h es e m e dic ati o ns i ncl u d e:  
•  
Pr ost a gl a n di ns – w hic h i ncr e as e scl er al o utfl o w of a q u e o us h u m or  
•  
B et a -a dr e n er gic r ec e pt o r a nt a g o nists w hic h d ecr e as e a q u e o us h u m or pr o d ucti o n 
•  
Al p h a 2 -a dr e n er gic a g o nists w hic h d ecr e as e a q u e o us h u m or pr o d ucti o n A N D 
i ncr e as e scl er al o utfl o w 
•  
Al p h a a g o nists –  w hic h g e n er ally d ecr e as e a q u e o us h u m or pr o d ucti o n  
•  
Mi otic a g e nts s uc h as pil oc ar pi n e w hic h  c a us e cili ary c o ntr acti o n a n d o p e ni n g of 
t h e dr ai n a g e a n gl e 
•  
C ar b o nic a n hy dr as e i n hi bit ors l o w er pr o d ucti o n of a q u e o us h u m or  
T hr o u g h dis e as e pr o gr essi o n, p o or c o m pli a nc e, si d e eff ects, a n d s o m eti m es li mit e d b e n efit, 
m e dic al m a n a g e m e nt oft e n b ec o m es i n a d e q u at e a n d s ur gic al i nt erv e nti o ns ar e t h e n r e q uir e d t o 
sl o w t h e pr o gr essi o n t o bli n d n ess. G e n er ally, t h es e o p er ati o ns pr ovi d e o nl y a t e m p or ary s ol uti o n 
b ec a us e sc arri n g, bl ock a g e a n d i nf ecti o ns li mit t h eir eff ecti v e n ess.  
2. 1. 2. 2  
S U R GI C A L  
C urr e nt s ur gic al pr o c e d ur es g e n er all y i n v ol v e s o m e f or m of tr a b ec ul ect o my or d e vic e b as e d 
dr ai n a g e i m pl a nt. T h e d evic es a n d pr oc e d ur es m a y b e a p pr o ac h e d t hr o u g h a b ext er n o ( o utsi d e i n) 
or a b i nt er n o (i nsi d e o ut) pr oc e d ur es. Fi g ur e 1 ill ustr at es gr a p hic all y b ot h t h e a b ext er n o  a n d a b 
i nt er n o a p pr o ac h es as t h e y r el at e s p ecific ally t o a c a n al o pl asty pr oc e d ur e . 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3  
Fi g ur e 1 :  a b e xt er n o a n d a b i nt er n o a p pr o ac h 
 
T h e m ost c o m m o n c o nv e nti o n al s ur g ery p erf or m e d f or gl a uc o m a is tr a b ec ul ect o m y. I n tr a diti o n al 
tr a b ec ul ect o my, a p arti al t hic k n ess fl a p is m a d e i n t h e scl er al w all of t h e ey e, a n d a wi n d o w o p e ni n g 
is m a d e u n d er t h e fl a p t o r e m o v e a p orti o n of t h e tr a b ec ul ar m es h w or k. T h e scl er al fl a p is t h e n 
s ut ur e d l o os ely b ack i n pl ac e t o all o w fl ui d t o fl o w o ut of t h e ey e t hr o u g h t his o p e ni n g, r es ulti n g i n 
l o w er e d I O P a n d t h e f or m ati o n of a bl e b or fl ui d b u b bl e o n t h e s urf ac e of t h e ey e, b ut u n d er t h e 
c o nj u nctiv a.  
T h e m o st c o m m o n ty p es of t u b e s h u nts ar e t h e A h m e d Gl a uc o m a V alv e, B a erv el dt, a n d M olt e n o.  
T h e y ar e m ost oft e n us e d aft er a f ail e d tr a b ec ul ect o my.  
L as ers c a n b e us e d t o a bl at e a n d o p e n t h e tr a b ec ul ar m es h w ork. Ar g o n l as er tr a b ec ul o pl asty ( AL T) 
us es a 5 0 -μ m ar g o n l as er t h at is ai m e d at t h e tr a b ec ul ar m es h w or k t o sti m ul at e o p e ni n g of t h e 
m es h w ork t o all o w m or e o utfl o w of a q u e o us fl ui d. A n e w er t y p e of l as er tr a b ec ul o pl ast y is c all e d 
s el ectiv e l as er tr a b ec ul o pl ast y ( SL T) a n d is t h o u g ht t o c a us e l ess d a m a g e t o t h e t r a b ec ul ar 
m es h w ork, b ut wit h c o m p ar a bl e effic ac y t o AL T. L as er p eri p h er al iri d ot o m y is us e d i n p ati e nts 
s usc e pti bl e t o or aff ect e d by a cl os e d a n gl e gl a uc o m a. H er e, l as er e n er g y is us e d t o m a k e a s m all, 
f ull-t hic k n ess o p e ni n g i n t h e iris t o e q u aliz e t h e press ur e b et w e e n t h e fr o nt a n d b ac k of t h e iris, t h us 
c orr ecti n g a n y a b n or m al b ul gi n g of t h e iris. Di o d e l as er cr y o a bl ati o n is us e d t o r e d uc e a q u e o us 
h u m or s ecr eti o n b y d estr oyi n g s ecr et or y cili ar y e pit h eli u m.  
2. 1. 2. 3  
MI G S  
R ec e ntly, Mi ni m ally I nv asi v e Gl a uc o m a S ur gic al ( MI G S) D evic es h av e b e e n d ev el o p e d t o e n h a nc e 
p hysi ol o gic a q u e o us h u m or o utfl o w, utilizi n g mi ni m ally i n v asiv e s ur gic al pr oc e d ur es. C o m plic ati o ns 
a n d l ac k of l o n g t er m eff ecti v e n ess of tr a diti o n al tr a b ec ul ect o m y a n d t u b e s h u nt s ur g eri es h av e l e d 
t o t h e e m er g e nc e of s ev er al n e w MI G S u n d er d e v el o p m e nt or r ec e ntl y i ntr o d uc e d t o t h e m ark et. 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4  
T h e d evic es s m all siz es mi ni miz e tr a u m a a n d all o w f or t h e s ur gic al i nt er v e nti o n of l ess s e v er e 
gl a uc o m a p ati e nts c o m p ar e d wit h t h e ty pic al i n dic ati o n f or tr a b ec ul o pl asty. T h e m ai n a dv a nt a g e of 
MI G S is t h at t h es e pr oc e d ur es ar e l ess i n v asiv e a n d s af er. I nf ecti o n is t h e m ost dr e a d e d 
c o m plic ati o n a n d c a n occ ur at a n y ti m e, e v e n y e ars aft er s ur g ery. T h e m ai n li mit ati o n of MI G S, 
h o w ev er, ar e t h at t h es e pr oc e d ur es d o n ot t y pic ally pr o d uc e as l ar g e a pr ess ur e l o w eri n g eff ect as 
tr a b ec ul ect o my d o es. I n a d diti o n, t h e r es ulti n g eff ect is n ot as r eli a bl e as t h at ac hi e v e d wit h 
tr a diti o n al filt eri n g pr oc e d ur es. T h er ef or e, c urr e ntl y av ail a bl e MI G S ar e g e n er ally r es erv e d f or 
p ati e nts wit h l ess a d v a nc e d dis e as e, or us e d i n c o m bi n ati o n wit h c at ar act s ur g ery.  
T o att e m pt t o l o w er I O P, MI G S s h u nt A H i nt o e ncl os e d s p ac es wit hi n t h e ey e: i nt o Sc hl e m m’s c a n al, 
t h e s u bc o nj u ncti v al s p ac e, or t h e s u pr ac h or oi d al s p ac e. Si nc e t h ey ar e i m pl a nt e d c o m pl et el y 
i nt er n al t o t h e ey e, t h e y ar e s u bj ect t o e nc a ps ul ati o n d u e t o i nfl a m m at ory f or ei g n b o dy r es p o ns e. I n 
a d diti o n, t h ey m ust c o nt e n d wit h e piscl er al v e n o us pr ess ur e as t h e fl ui d is a bs or b e d a n d r et ur n e d t o 
t h e bl o o dstr e a m. Alt h o u g h th e y s e e m t o b e r el ativ el y s af e, n o n e h as b e e n a bl e t o c o nsist e ntly l o w er 
I O P t o a l ev el t h at h alts gl a uc o m a pr o gr essi o n, i. e., t hr es h ol d I O P ( ≤1 2 m m H g). T h e i St e nt w as  t h e 
first MI G S d e vic e  t o r ec ei v e C E M ar k a n d F D A a p pr ov al . C o m p ari n g a n i St e nt i m pl a nt e d i n 
c o nj u ncti o n wit h c at ar act s ur g er y t o c at ar act s ur g ery al o n e, littl e diff er e nc e w as f o u n d i n p ost -o p 
I O Ps. Aft er o n e y e ar, t h er e w er e 2 0 % l ess m e dic ati o ns n e e d e d i n t h e st u dy ar m wit h t h e i St e nt pl us 
c at ar act s ur g er y i n t his u n m as k e d st u dy, b ut aft er t w o y e ars e v e n t his s m all diff er e nc e h a d 
dis a p p e ar e d. 1 D a vi d Fri e d m a n “c a uti o n e d t h at t h er e is li mit e d evi d e nc e r e g ar di n g t h e effic ac y of 
t h es e n e w er gl a uc o m a pr oc e d ur es”.2   D a vi d E pst ei n wr ot e a b o ut Sc hl e m m’s c a n al s ur g er y t h at “it is 
i m p ort a nt t o r e m e m b er t h at t h es e o p er ati o ns m ay n ot g et t h e I O P as l o w as d esir e d.” 3   
MI G S d evic es c a n b e als o b e cl assifi e d as a b ext er n o ( o utsi d e i n) or a b i nt er n o (i nsi d e o ut).  
T h e a b ext er n o MI G S i ncl u d e:  
•  
E arl y v al v e d i m pl a nts s uc h as t h e A h m e d Gl a uc o m a V al v e i m pl a nt. T h e y w or k by utilizi n g a s m all 
fl o w t u b e t h at is i ns ert e d i nt o t h e a nt eri or c h a m b er of t h e ey e w hic h is c o n n ect e d t o a 
s u bscl er al pl at e i m pl a nt e d u n d er n e at h t h e c o nj u nctiv a t o all o w fl o w of a q u e o us fl ui d o ut of t h e 
e y e i nt o a c h a m b er c all e d a bl e b . 
•  
T h e Ex -P R E S S gl a uc o m a filtr ati o n d evic e ( Alc o n): is a 0. 4 x 3 m m st ai nl ess st e el mi ni -s h u nt dr ai ns 
a q u e o us fl ui d i nt o t h e s u bc o nj u ncti v al s p ac e a n d is us e d i n c o nj u ncti o n wit h st a n d ar d 
tr a b ec ul ect o my s ur g ery. It is pl ac e d u n d er t h e scl er al fl a p a n d i nt o t he a nt eri or c h a m b er s o n o 
scl er ect o my or iri d ect o my is r e q uir e d.  
•  
C a n al o pl asty (i Sci e nc e I nt er v e nti o n al. T his is acc o m plis h e d b y p assi n g a 9 -0 or 1 0 -0 pr ol e n e 
s ut ur e 3 6 0 d e gr e es t hr o u g h Sc hl e m m's c a n al wit h t h e ai d of a micr o -c at h et er a n d visc o el astic t o 
di l at e t h e c a n al. T h e s ut ur e is ti e d ti g htl y i n or d er t o k e e p t h e c a n al o p e n.  
•  
E n d osc o pic Cycl o p h ot oc o a g ul a ti o n – E C P -( E n d o O pti ks): e n d ol as er c ycl o p h ot oc o a g ul ati o n is us e d 
f or s el ectiv e a bl ati o n of t h e pi g m e nt e d cili ar y e pit h eli u m t o r e d uc e a q u e o us pr o d ucti on.  
T h e a b i nt er n o s ur g eri es i ncl u d e:  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5  
•  
i St e nt tr a b ec ul ar micr o-by p ass ( Gl a u k os): t his s m all tr a ns tr a b ec ul ar tit a ni u m st e nt dr ai ns 
a q u e o us fl ui d i nt o Sc hl e m m's c a n al. T h e d evic e is pl ac e d t hr o u g h a cl e ar c or n e al i ncisi o n wit h 
t h e ai d of a g o ni osc o py l e ns. 
•  
C y P ass ( Tr a nsc e n d M e dic al): t his s u pr acili ary micr ost e nt i ncr e as es u v e oscl er al o utfl o w. It is 
i m pl a nt e d t hr o u g h a cl e ar c or n e al i ncisi o n a n d c a n b e c o m bi n e d wit h c at ar act s ur g er y.  
•  
G ol d micr o -s h u nt ( S OL X): t his is a 3 x 6 m m d evic e t h at is l ess t h a n 0. 1 m m  t hic k. It is pl ac e d i nt o 
t h e s u pr acili ary s p ac e t hr o u g h a 3 m m i ncisi o n t o i ncr e as e uv e oscl er al o utfl o w.  
•  
Tr a b ect o m e ( N e o M e dix): t his is a t h er m al c a ut ery d evic e wit h irri g ati o n a n d as pir ati o n a n d a 
pr ot ecti v e f o ot pl at e. It is us e d t o a bl at e a 2 - t o 4-cl ock h o ur s e g m e nt of tr a b ec ul ar m es h w or k 
a n d Sc hl e m m’s c a n al u n d er dir ect vis u aliz ati o n  
•  
X E N G el St e nt ( A q u e S ys):  t his is a 6 m m l o n g by ~ 1 0 0 micr o n wi d e micr o s h u nt t h at is i nj ect e d 
t hr o u g h a s m all s elf-s e ali n g c or n e al i ncisi o n t o s h u nt fl ui d t o a bl e b i n t h e s u bc o nj u ncti v al s p ac e. 
T h e X E N is i n pr e m ark et p h as e i n t h e U S.  
•  
I n n F oc us Micr o S h u nt (I n n F oc us):  t his is a n 8. 5 m m l o n g t u b e wit h a 3 5 0 micr o n di a m et er t h at 
s h u nts a q u e o us fr o m t h e a nt eri or c h a m b er t o a s u bc o nj u ncti v al/s u b -t e n o n fl a p.  It is i n 
pr e m ar k et p h as e i n t h e U S.  
 
2. 1. 3  D E VI C E D E S C RI P TI O N  
 
 
 
   
 
 
 
 
 
  
 
 
 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
.  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
7  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
8  
 
 
     
2. 2  
R A TI O N A L E  
Gl a uc o m a is t h e l e a di n g c a us e of irr ev ersi bl e bli n d n ess i n t h e w orl d, a n d r e m ai ns a l ar g el y u n m et cli nic al 
n e e d. T o d a y’s tr e at m e nts ar e g e n er ally t e m p or ary i n eff ect, ass oci at e d wit h hi g h r at es of c o m plic ati o ns, 
or d o n ot l o w er I O P s uffici e ntl y t o h alt t h e pr o gr essi o n t o bli n d n ess  wit h o ut c o nc o mit a nt t h er a pi es . 
Micr o O ptx h as d ev el o p e d t h e B GI –  pr o misi n g t ec h n ol o gy t h at is e n gi n e er e d t o s af el y, c o nsist e ntly 
l o w er I O P t o b el o w t hr es h ol d ( 1 2 m m H g), l o w e n o u g h t o h alt f urt h er d a m a g e t o t h e o ptic n erv e a n d 
pr es er v e visi o n. T his cli nic al i nv esti g ati o n is a first -i n-h u m a n f e asi bility st u dy , i n s u bj ects wit h o ut us ef ul 
visi o n, t o c o nfir m fi n di n gs fr o m ri g or o us b e nc h a n d a ni m al st u di es, a n d t o d et er mi n e if f urt h er 
i nv esti g ati o n a n d d ev el o p m e nt of t h e B GI  is w arr a nt e d.   
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
9  
 
2. 3  
P O T E N TI A L RI S K S A N D B E N E FI T S  
 
2. 3. 1  K N O W N P O T E N TI A L RI S K S  
K n o w n p ot e nti al ris ks of  t h e B GI a n d t h e ass oci at e d i m pl a nt pr oc e d ur e m a y i ncl u d e: 
•  
A d v er s e R e s ul t t o P ati e nt 
•  
A b ort e d Pr o c e d ur e  
•  
Bl e e di n g  
•  
C at ar a ct f or m ati o n or 
pr o gr e s si o n  
•  
C h or oi d al d et a c h m e nt  
•  
C h or oi d al eff u si o n r e q uiri n g 
s ur gi c al dr ai n a g e  
•  
C h a n n el bl o c k a g e  
•  
C hr o ni c iriti s  
•  
C or n e al H a z e/ O p a cit y  
•  
C or n e al f al s e tr a ct a b o v e 
D e s c e m et’ s m e m br a n e  
•  
C or n e al N e o v a s c ul ari z ati o n  
•  
C o nj u n cti v al o v er gr o wt h  
•  
C or n e al e n d ot h eli al t o u c h  
•  
D e at h  
•  
D el a y e d Pr o c e d ur e  
•  
D e p o sit s o n d e vi c e  
•  
D e vi c e m alf u n cti o n  
•  
D e vi c e Mi gr ati o n or 
Di sl o d g e m e nt  
•  
D e vi c e R ej e cti o n  
•  
E n d o p ht h al miti s  
•  
Fl at a nt eri or c h a m b er r e q uiri n g 
a nt eri or c h a m b er r ef or m ati o n  
•  
F o c al c o nj u n cti v al h y p er pl a si a  
•  
I nf e cti o n 
 
•  
I nfl a m m ati o n i n cl u di n g iri s, 
m a c ul ar a n d c or n e al e d e m a  
•  
H e m at o m a or H e m orr h a g e 
i n cl u di n g s u pr a c h or oi d al or 
vitr e o u s h e m orr h a g e  
•  
H y p h e m a  
•  
H y p ot o n y (I O P < 6 m m H g w h e n 
c o n s ci o u s)  
•  
H y p ot o n y m a c ul o p at h y  
•  
I n cr e a s e d t e ari n g 
•  
O c ul ar Tr a u m a  
•  
P eri p h er al fl o w/ w o u n d l e a k  
•  
P er m a n e nt L o s s of Vi si o n  
•  
P ht hi si s / atr o p h y ( s hri n k a g e of 
t h e e y e) 
•  
Pt o si s  
•  
P yr o g e ni c  
•  
R e -i nt er v e nti o n 
•  
R eti n al D et a c h m e nt  
•  
S e c o n d ar y s ur gi c al i nt er v e nti o n s  
•  
S u b st a nti al i n cr e a s e i n I O P v s. 
b a s eli n e  
•  
S e v er e Irrit a ti o n i n cl u di n g 
C hr o ni c Iriti s  
•  
T e m p or ar y H y p ot o n y a s s o ci at e d 
wit h G e n er al A n e st h e si a  
•  
T e m p or ar y L o s s of Vi si o n  
•  
T o xi cit y  
•  
U s er Di s s ati sf a cti o n  
•  
R etr o gr a d e fl o w a n d i n cr e a s e d 
I O P wit h s wi m mi n g/ di vi n g 
 
T h er e m ay als o b e ot h er risks r el at e d t o t h e B GI a n d ass oci at e d i m pl a nt pr oc e d ur e t h at ar e n ot list e d or 
t h at ar e n ot k n o w n at t his ti m e. T his st u dy will h el p c h ar act eriz e t h e a dv ers e e v e nts ass oci at e d wit h t h e 
B GI i m pl a nt.   

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 0  
2. 3. 2  K N O W N P O T E N TI A L B E N E FI T S  
K n o w n p ot e nti al b e n efits of t h e B GI i ncl u d e:  
•  
Cli nic all y m e a ni n gf ul r e d ucti o ns i n I O P  
•  
L u bric ati o n of c or n e a, pr o vi di n g r eli ef/tr e at m e nt of oc ul ar s urf ac e dis e as es ( O S D) 
i ncl u di n g dr y e y e 
•  
R e d uc e d n e e d f or I O P l o w eri n g m e dic ati o ns  
•  
R e d uc e d n e e d f or O S D m e dic ati o ns  
•  
P ai n (r es ulti n g fr o m exc essiv e I O P) r eli ef  
•  
Li mit e d p ost-o p er ativ e f oll o w -u p c ar e r e q uir e m e nts  
 
2. 3. 3  S T U D Y RI S K MI T I G A TI O N  
T h e f oll o wi n g m e as ur es will b e t a k e n i n t h e cli nic al st u dy t o miti g at e or mi ni miz e ris ks t o st u dy s u bj ects 
t h at m a y b e ass oci at e d wit h i m pl a nt ati o n of t h e B GI  a n d h a v e b e e n i d e ntifi e d i n a f or m al risk 
ass ess m e nt : 
1.  I m pl a nti n g I nv esti g at or s ur g e o ns will r ec eiv e di d actic tr ai ni n g fr o m Micr o O ptx  pri or t o p erf or mi n g 
st u dy i m pl a nts. 
2.  I m pl a nti n g I nv esti g at or s ur g e o ns will r ec ei v e pr ecli nic al c a d a v er a n d/ or a ni m al m o d el 
i m pl a nt ati o n tr aini n g fr o m  Micr o O ptx  pri or t o p erf or mi n g st u dy i m pl a nts . 
3.  As p art of pr ecli nic al tr ai ni n g f or I nv esti g at ors, si m ul at e d fr a g m e nt r e m ov al will b e pr es e nt e d. 
4.  T h e pr ot oc ol a n d I nv esti g at or tr ai ni n g will i nstr uct t o vis u ally ex a mi n e t h e B GI d evic e aft er 
r e m o v al f or evi d e nc e of d el a mi n ati o n a n d/ or b o n d f ail ur e u n d er t h e o p er ati o n micr osc o p e . 
5.  I nv esti g at ors will b e tr ai n e d pri or t o f oll o w-u ps o n t h e n or m al a p p e ar a nc e of a d e vic e i m pl a nt sit e . 
6.  T h e pr ot oc ol a n d I nv esti g at or tr ai ni n g will d escri b e l o oki n g f or a b n or m al fi n di n gs s uc h as uv ei tis, 
c or n e al h azi n g a n d fl ar e, a n d for m ati o n of fi bri n i n t h e a nt eri or c h a m b er as si g ns of p ot e nti al l oss 
of bi oc o m p ati bility.  
7.  Micr o O ptx will pr oct or t h e first t hr e e i m pl a nts at e ac h e nr olli n g c e nt er. 
8.  I m pla nt e rs m ust b e c ertifi e d b y Micr o O ptx aft er tr ai ni n g a n d pr oct or e d i m pl a nts, pri or t o 
p erf or mi n g  i m pl a nts o n t h eir o w n. 
9.  E as e of i m pl a nt will b e ass ess e d o n t h e I m pl a nt c as e r e p ort f or m .  
1 0.  P ati e nt f oll o w -u ps , i ncl usi v e of a slit l a m p ex a mi n ati o n , occ ur at B a s eli n e, D ay 1, W e ek 1, W e e k 2, 
a n d M o nt h s 1, 2, 3, 6, 1 2 , a n d 2 4 as d escri b e d i n A N SI -Z 8 0 5, a n d will i ncl u d e a n ass ess m e nt f or 
e pit h eli al i n gr o wt h i n t h e a nt eri or s e g m e nt . 
1 1.  A q u e o us fl o w t hr o u g h a n d n ot ar o u n d t h e d e vic e will b e ass ess e d vi a t h e S ei d el fl u or esc ei n t est at 
all p ati e nt f oll o w -u ps st arti n g wit h t h e W e e k 1  visit. 
1 2.  T h e i m pl a nt pr oc e d ur e will us e 1. 4  m m k er at o m e w hic h , d u e t o t h e cr oss b ar t a b, will pr e v e nt 
i nt er n al mi gr ati o n of t h e d e vic e . 
1 3.  T h e I nstr ucti o ns f or Us e (I F U) will d escri b e t h e pr oc ess a n d crit eri a f or d e vic e i ns p ecti o ns b y t h e 
i m pl a nti n g s ur g e o n. 
1 4.  T his pr ot oc ol a n d t h e I F U will pr o vi d e g e n er al r ec o m m e n d ati o ns f or ex pl a nt pr oc e d ur e . 
1 5.  T h e pr ot oc ol r e q uir es c o nt i n u e d f oll o w-u p of s u bj ects aft er r e m ov al u ntil h e ali n g is st a biliz e d. 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 1  
1 6.  E as e of ex pl a nt will b e ass ess e d o n t h e Ex pl a nt ati o n c as e r e p ort f or m .  
1 7.  Hy p ot o ny m a n a g e m e nt str at e gi es  ar e  d escri b e d i n t his pr ot oc ol a n d I F U , i ncl u di n g m e dic al 
m a n a g e m e nt or d e vic e ex p l a nt ati o n. 
1 8.  B est C orr ect e d Vis u al Ac uity will b e ass ess e d at B as eli n e, W e e k 1, W e e k 2, a n d M o nt h s 1, 2, 3, 6, 
1 2 , a n d 2 4. 
1 9.  O ptic n erv e i m a g e a n alysis will b e p erf or m e d at B as eli n e  a n d  M o nt h s 6, 1 2 , a n d 2 4 . 
2 0.  P eri m etr y will b e p erf or m e d at B as eli n e  a n d  M o nt h s 6, 1 2 , a n d M o nt h 2 4 . 
2 1.  T h e T S Q p ati e nt q u esti o n n air e  will b e c o m pl et e d at B as eli n e a n d M o nt hs 1, 3, 6, 1 2, a n d 2 4.  
2 2.  T h e cli nic al tri al Im pl a nt a n d f oll o w -u p cas e re p ort for ms will i ncl u d e a f orc e d c h oic e o pti o n f or 
t h e pr es e nc e or a bs e nc e of d e bris a n d , if pr es e nt, a pr o m pt t o r ec or d a d escri pti o n of d e bris a n d 
s o urc e if k n o w n. 
2 3.  T h e Ex pl a nt c as e re p ort f or m will i ncl u d e a f orc e d c h oic e o pti o n t o d escri b e if t h e d e vic e is i nt act, 
p arti all y i nt act , or n ot i nt act b as e d u p o n ex a mi n ati o n u n d er t h e o p er ati n g micr osc o p e . 
2 4.  Ex pl a nt e d d evic es will b e r et ur n e d t o Micr o O ptx f or p erf or m a nc e t esti n g , i ncl u di n g ass ess m e nt of 
t h e h y dr o gel  l ay er a n d fl o w.S e nsitiz ati o n will b e m o nit or e d vi a: B est C orr ect e d Vis u al Ac uit y, 
A p pl a n ati o n T o n o m etr y, C e ntr al C or n e al T hic k n ess, I O P m e as ur e m e nts, G o ni osc o py, l e ns st at us, 
slit la m p e x a mi n ati o ns, V ertic al C/ D R ati o Ass ess m e nts, d il at e d fu n d us ex a ms, o ptic n erv e im a g e 
a n al ysis, p eri m etr y , a n d a p ati e nt q u esti o n n air e at f oll o w -u p ex a mi n ati o ns as d escri b e d i n t h e 
st u dy pr ot oc ol . 
2 5.  M o nit or f or si g ns of i m pl a nt ati o n sit e eff ects at B as eli n e, D ay 1, W e ek 1, W e e k 2, a n d M o nt h s 1, 2, 
3, 4. 5 6, 8, 1 0 1 2 , 1 5, 1 8 , 2 1a n d 2 4,  p er pr ot oc ol.  
a.  F oll o w -u p cas e re p ort for m s will h av e a f orc e d ch oic e o pti o n t o d escri b e t h e i m pl a nt sit e 
as n or m al or a b n or m al a n d as k f or a d escri pti o n . 
b.  F oll o w -u p cas e re p ort for m s will h av e a st a n d ar diz e d sc al e f or ass ess m e nt of t h e i m pl a nt 
sit e. 
2 6.  M o nit or f or si g ns of el ev at e d b o dy t e m p er at ur e B as eli n e, D ay 1, W e ek 1, W e e k 2, a n d M o nt h s 1, 
2, 3, 4. 5 6,  8, 1 0,  1 2 , 1 5,  1 8 , 2 1 a n d 2 4,  a n d pr es e nc e  of a n i d e ntifi a bl e eti ol o gy f or t h e f e v er . 
2 7.  M o nit or f or si g ns of a b n or m al r es p o ns e t o i m pl a nt or si g ns of t oxicity at B as eli n e, D ay 1, W e e k 1, 
W e ek 2, a n d M o nt h s 1, 2, 3,  4. 5 6, 8, 1 0 1 2 , 1 5,  1 8 , 2 1 a n d 2 4  f oll o w-u p visits . 
2 8.  S p ecific pr ot oc ol r e q uir e m e nts at f oll o w-u p  ex a mi n ati o ns  i ncl u d e t h e slit la m p a n d d il at e d fu n d us 
e x a mi n ati o ns t h at c a n d et ect t h e pr es e nc e of l oss of bi oc o m p ati bilit y a n d a n a b n or m al r es p o ns e 
t o t h e d evic e. 
a.  Si g ns of a n a b n or m al r es p o ns e  i ncl u d e hy p er pl astic a n d n ecr otizi n g tiss u e r e acti o ns as 
disc o v er a bl e by slit la m p a n d dil at e d f u n d us ex a mi n ati o ns at sc h e d ul e d f oll o w -u ps . 
2 9.  I nv esti g at ors c a n r ef er t o i nf ecti o us s p eci alists or ot h er o p ht h al mic s p eci alists s uc h as r eti n al 
s ur g e o ns, if n e e d e d. 
3 0.  T h e pr ot oc ol i ncl u d es ass ess m e nt f or si g ns of T A S S, i ncl u di n g s y m pt o ms of s ev er e a nt eri or 
c h a m b er i nfl a m m ati o n wit hi n 1 2 -4 8 h o urs’ p ost -o p er ati v e p eri o d i n dic at e d by:  
a.  C or n e al e d e m a ext e n di n g fr o m li m b us t o li m b us .  
b.  Dil at e d or irr e g ul ar p u pil .  
c. I ncr e as e d i ntr a oc ul ar pr ess ur e.  
d.  Hy p o py o n . 
3 1.  S u bj ects will b e ex a mi n e d f or si g ns of oc ul ar p at h ol o gy at e ac h sc h e d ul e d f oll o w -u p visit.  
2. 3. 4  S U M M A R Y O F B E N E FI T V E R S U S RI S K   

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 2  
Gi v e n t h e d esi g n a n d i nt e n d e d us e of t h e d evic e, i nf ecti o n a n d h y p ot o ny ar e p er h a ps t h e m ost s eri o us 
ris ks p os e d. Ext e nsiv e b e nc h a n d a ni m al st u di es ( gr e at er t h a n 5 0 i m pl a nts) s u g g est t h at d esi g n f e at ur es 
of t h e d evic e, p artic ul arl y t h e hi g hl y hy dr o p hilic hy dr o g el c o nstr uct of t h e i n n er fl o w c h a n n el, ar e 
eff ectiv e i n r esisti n g i nf ecti o n –  wit h n o cli nic al e vi d e nc e of a n y i nf ecti o n, c o nfir m e d b y n e g ati v e c ult ur e. 
N o c as es of h y p ot o ny h av e b e e n o bs er v e d, ev e n i n t h e pr es e nc e of m ulti pl e i m pl a nts i n a si n gl e e y e.  
D evic e disl o d g m e nts h av e b e e n o bs er v e d wit h e arli er v ersi o ns of t h e d evic e. I n all c as es of disl o d g m e nt, 
t h e w o u n d s p o nt a n e o usly h e al e d wit h n o cli nic al s e q u el a e –  i ncl u di n g i nf ecti o n. Als o i n all c as es, 
disl o d g e m e nts w er e pr ec e d e d b y vis u al si g ns of c o nj u ncti v al hy p er pl asi a a n d p eri p h er al l e a k a g e of 
a q u e o us h u m or ar o u n d t h e d e vic e. Wit h r es p ect t o disl o d g m e nts, it is i m p ort a nt t o n ot e t h at t h e 
i ncisi o n m a d e at i m pl a nt is l ess t h a n h alf t h e siz e of t h os e m a d e d uri n g c at ar act s ur g er y, a n d t h os e ar e 
d o n e  wit h o ut s ut uri n g aft er t h e pr oc e d ur e. T h e B GI –  fl at, at j ust 1 5 0 micr o ns t hic k - is pl ac e d t hr o u g h 
t h e s m all i ncisi o n, filli n g t h e i ncisi o n al s p ac e. U p o n disl o d g m e nt, t h e ori gi n al i ncisi o n h as s p o nt a n e o usl y 
cl os e d - j ust as i n t h e c as e wit h t h e l ar g er i ncisi o ns m a d e d uri n g c at ar act s ur g ery.   
T h e i nt e n d e d p ati e nt p o p ul ati o n f or t his f e asi bility st u dy ar e p ati e nts wit h el ev at e d I O P b ut w h o h av e 
l ost us ef ul visi o n. Th es e p ati e nts m ay b e  o n m e dic at e d e y e dr o ps t h at c a n c a us e p ai n , irrit ati o n, a n d 
disc o mf ort o n t h e e y e. Fi n ally, s o m e of t h es e p ati e nts m a y ev e n ex p eri e nc e p ai n r es ulti n g fr o m 
exc essi v e I O P, d es pit e m e dic ati o ns a n d ot h er pr ess ur e -r e d uci n g t h er a pi es.   
T h e B GI h as t h e p ot e nti al t o r e d uc e i ntr a -oc ul ar pr ess ur e i n t h es e p ati e nts, r eli evi n g pr ess ur e -ass oci at e d 
p ai n a n d s p ari n g w h at ev er visi o n m ay b e l eft. T h e B GI will als o pr ovi d e l u bric ati o n t o t h e s urf ac e of t h e 
e y e, r eli evi n g p ai n a n d irrit ati o n ass oci at e d wit h m e dic at e d e y e dr o ps or ot h er f or m of oc ul ar s urf ac e 
dis e as e. W hil e i m pl a nt ati o n  of a B GI is ass oci at e d wit h ris ks ( e. g. i nf ecti o n, h y p ot o ny, disl o d g m e nt, etc.), 
t h e p ot e nti al b e n efit of B GI i m pl a nt ati o n s h o ul d offs et t h os e ris ks i n t his p ati e nt p o p ul ati o n, p artic ul arl y 
c o nsi d eri n g us ef ul visi o n h as alr e a dy b e e n l ost . 
3  
O BJ E C TI V E S A N D  P U R P O S E  
T h e p ur p os e of t his cli nic al st u dy is t o ass ess t h e  s af ety a n d f e asi bility of l o w eri n g i ntr a oc ul ar pr ess ur e 
wit h t h e Br o w n Gl a uc o m a I m pl a nt. T h e o bj ectiv es ar e t o d e m o nstr at e f e asi bilit y of eff ectiv e n ess b y 
o bs ervi n g a cli nic ally m e a ni n gf ul r e d uct i o n fr o m b as eli n e i n di ur n al I O P, a n d t o d e m o nstr at e f e asi bility 
of s af et y b y o bs ervi n g a s af et y pr ofil e t h at is s uffici e nt t o w arr a nt f urt h er st u dy. St u dy s u bj ects will b e 
wit h b est c orr ect e d vis u al ac uit y of s e v er e vis u al i m p air m e nt ( 2 0/ 4 0 0) or w ors e, , ha v e el ev at e d I O P, a n d 
m a y or m ay n ot h av e gl a uc o m a.  
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 3  
4  
S T U D Y D E SI G N A N D E N D P OI N T S  
 
4. 1  
D E S C RI P TI O N O F T H E S T U D Y D E SI G N  
T his Cli nic al I nv esti g ati o n S u m m ary is d e v el o p e d wit h r ef er e nc e t o I S O 1 4 1 5 5: 2 0 1 1, t h e A m eric a n 
N ati o n al St a n d ar d f or O p ht h al mics –  I m pla nt a bl e Gl a uc o m a D evic es ( A N SI Z 8 0. 2 7 -2 0 1 4), F D A’s 
Pr e m ar k et St u di es of I m pl a nt a bl e Mi ni m ally I nv asiv e Gl a uc o m a S ur gic al ( MI G S) D evic es G ui d a nc e 
d oc u m e nt, a n d ot h er s o urc es.  
T h e tri al is a pr os p ecti v e, n o n -r a n d o miz e d, si n gl e ar m, m ulti -c e nt er ( 3), e arly f e asi bilit y  st u dy i n s u bj ects 
wit h el e v at e d I O P b ut w h o h a v e l ost us ef ul visi o n . All s u bj ects will b e f oll o w e d t hr o u g h t w o y e ars p ost -
i m pl a nt, b ut m ay t h e n b e e nr oll e d i n a l o n g -t er m f oll o w-u p r e gistry . 
O nly o n e ey e p er st u dy su bj ect will b e i m pl a nt e d wit h a B GI. If b ot h ey es ar e eli gi bl e, t h e e y e wit h t h e 
hi g h est i ntr a -oc ul ar pr ess ur e will b e s el ect e d f or i m pl a nt.  
4. 1 . 1 P RI M A R Y E N D P OI N T  
T h e pri m ar y eff ecti v e n ess e n d p oi nt is a r es p o n d er o utc o m e, wit h a r es p o n d er d efi n e d as a s u bj ect wit h 
a r e d ucti o n i n i ntr a-oc ul ar pr ess ur e of at l e ast 2 0 % fr o m b as eli n e t o six m o nt hs p ost -i m pl a nt. B ec a us e 
t his f e asi bility st u dy is n ot st atistic ally p o w er e d, t his e n d p oi nt will b e ev al u at e d q u alit ati v ely, a n d n o 
f or m al t ests of hy p ot h esis ar e pl a n n e d.   
A ny  I O P-l o w eri n g m e dic ati o ns  s h o ul d b e st a biliz e d at l e ast 3 0 d ays pri or t o b as eli n e m e as ur e m e nts . T h e 
i ncr e m e nt al eff ectiv e n ess of t h e B GI i n r e d uci n g I O P r el ati v e t o st a bl e m e dic al t h er a py will b e ass ess e d.    
S af et y will b e ev al u at e d by ass essi n g t h e r at e of all A Es, S A Es, A D Es, S A D Es a n d U A D Es  - as w ell as 
e v al u ati o n of pr oc e d ur e -r el at e d c o m plic ati o ns, slit l a m p a n d f u n d us ex a mi n ati o n fi n di n gs, a n d s p ec ul ar 
micr osc o py  fi n di n gs - t hr o u g h t h e six-m o nt h p ost -i m pl a nt visit. All s uc h s af ety o utc o m es will b e 
c oll ect e d a n d s um m ariz e d f or t h e 6 m o nt h ti m e p oi nt. S af et y d at a will c o nti n u e t o  b e c oll ect e d a n d 
s u m m ariz e d i n a n y u p d at e r e p orts b e y o n d six m o nt hs. 
4. 1 . 2 S E C O N D A R Y E N D P OI N T S  
B ec a us e t his f e asi bilit y st u dy is n ot st atistic ally p o w er e d, n o f or m al t ests of h y p ot h esis ar e pl a n n e d a n d 
n o m et h o d t o c o ntr ol ty p e I err or f or t h e f a mily of s ec o n d ar y e n d p oi nts is n ec ess ar y. S p ecific s ec o n d ar y 
e n d p oi nts of i nt er est ar e:  
•  
M e a n c h a n g e fr o m b as eli n e i n di ur n al I O P  
•  
R es p o n d er r at e, wit h r es p o n d er d efi n e d as ac hi evi n g f oll o w -u p I O P l ess t h a n or e q u al t o 14 m m H g  
•  
C h a n g es i n I O P -l o w eri n g m e dic ati o ns 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 4  
4. 1 . 3 E X P L O R A T O R Y E N D P O I N T S 
E x pl or at ory e n d p oi nts i ncl u d e:  
•  
C h a n g es fr o m b as eli n e i n t h e Sc hir m er T e ar T est  
•  
Tr e at m e nt s atisf acti o n q u esti o n n air e at six m o nt hs p ost i m pl a nt ( T S Q)  
Ot h er d at a t o b e r e p ort e d i ncl u d e a c u m ul ati v e pr o p orti o n of r es p o n d er a n al ysis, s o t h at t h e e ntir e 
distri b uti o n of tr e at m e nt r es p o ns e is d e pict e d i n a gr a p h of t h e pr o p orti o n of r es p o n d ers f or all 
p erc e nt a g es of I O P r e d ucti o n. I n t his m a n n er, t h e n u m b er of p ati e nts wit h ≥5 0 % I O P r e d ucti o n c a n b e 
d et er mi n e d, f or ex a m pl e.  
5  
S T U D Y E N R O L L M E N T A N D WI T H D R A W A L  
 
5. 1  
P A R TI CI P A N T  I N C L U SI O N C RI T E RI A 
I ncl usi o n Crit eri a 
1.  A g e 2 2 y e ars a n d ol d er . 
2.  B est c orr ect e d vis u al ac uit y of 2 0/ 4 0 0 or w ors e i n t h e st u dy ey e. 
3.  F ell o w e y e wit h vis u ally ac uit y of 2 0/ 2 0 0 or b ett er a n d t h e vis u al fi el d n o w ors e t h a n st u dy e y e.  If 
t h e st u dy ey e h as n o li g ht p erc e pti o n, t h e f ell o w e y e m a y h a v e  n o li g ht p erc e pti o n or b ett er.  
4.  Intr a oc ul ar  pr ess ur e  i n t h e st u dy ey e gr e at er t h a n  or e q u al t o 2 1  m m H g a n d l ess t h a n or e q u al t o 
5 0 m m H g . 
5.  Pri m ar y o p e n -a n gl e gl a uc o m a (c o nfir m e d by g o ni osc o py).   
6.  Gl a uc o m at o us o ptic n er v e d a m a g e as evi d e nc e d b y a ny of t h e f oll o wi n g o ptic disc or r eti n al n er v e 
fi b er l a y er str uct ur al a b n or m aliti es:  
( 1) Diff us e t hi n ni n g, f oc al n arr o wi n g, or n otc hi n g of t h e o ptic disc ri m, es p eci all y at t h e i nf eri or or 
s u p eri or p ol es wit h or wit h o ut disc h e m orr h a g e;  
( 2) L oc aliz e d a b n or m aliti es of t h e p eri p a pill ary r eti n al n er v e fi b er l ay er, es p eci ally at t h e i nf eri or or 
s u p eri or p ol es; or  
( 3) O ptic disc n e ur al ri m asy m m etr y of t h e t w o ey es c o nsist e nt wit h l oss of n e ur al tiss u e 
7.  H u m p hr e y Vis u al Fi el d  ( H VF) d e m o nstr ati n g vis u al fi el d d ef ects c o nsist e nt wit h gl a uc o m at o us o ptic 
n er v e d a m a g e:  
F or m o d er at e gl a uc o m at o us l oss  
 - M e a n d evi ati o n >  6 d B  <  -1 2 d B  
 - F e w er t h a n 3 7 p oi nts d e pr ess e d b el o w t h e 5 % pr o b a bilit y l ev el a n d f e w er t h a n 2 0 p oi nts 
b el o w t h e p < 1 % l ev el  
 - N o a bs ol ut e  d eficit i n t h e c e ntr al 5 d e gr e es  
 - O nly o n e h e mifi el d wit h s e nsiti vity of < 1 5 d B i n t h e 5 c e ntr al d e gr e es  
F or a d v a nc e d Gl a uc o m a t o us l oss 
- 
M e a n d evi ati o n  > -1 2 d B  
- 
M or e t h a n 3 7 p oi nts d e pr ess e d b el o w t h e 5 % pr o b a bilit y l ev el a n d m or e t h a n 2 0 
p oi nts b el o w t h e p < 1 % l ev el  
- 
A bs ol ut e d eficit i n t h e c e ntr al 5 d e gr e es  
- 
S e nsiti vity < 1 5 d B i n t h e 5 c e ntr al d e gr e es i n b ot h h e mifi el ds  
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 5  
 
i n 
8.  At l e ast t w o c o nti g u o us cl oc k h o urs of i nt act c o nj u nctiv a n e ar t h e li m b us b et w e e n cl ock h o urs of 
9 : 0 0 a n d 0 3: 0 0 i n t h e st u dy e y e . 
9.  A d e q u at e s p ac e i n t h e a nt eri or c h a m b er of t h e st u dy ey e s uffici e nt t o s u p p ort i m pl a nt wit h t h e B GI, 
d efi n e d as t w o c o nti g u o us cl oc k h o urs of scl er al s p ur vis u aliz ati o n vi a g o ni osc o py, wit h o ut 
c o m pr essi o n, i n t h e s u p eri or 1 8 0 d e gr e es of t h e a nt eri or a n gl e.   
1 0.  A bl e a n d willi n g t o c o m pl y wit h pr ot oc ol r e q uir e m e nts . 
1 1.  A bl e t o u n d erst a n d a n d si g n t h e I nf or m e d C o ns e nt f or m.  
 
5. 2  
P A R TI CI P A N T  E X C L U SI O N C RI T E RI A  
1.  Acti v e N e o v asc ul ar Gl a uc o m a  i n t h e st u dy ey e. 
2.  Pi g m e nt ar y gl a uc o m a.  
3.  Ps e u d o exf oli ativ e gl a uc o m a . 
4.  C or n e al c o n diti o ns i n t h e st u dy e y e t h at m a y i n hi bit n or m al i ncisi o n al h e ali n g ( e. g. F uc h’s dystr o p hy) 
or i m p air vis u aliz ati o n of t h e i m pl a nt i nsi d e t h e a nt eri or c h a m b er .   
5.  A ntici p at e d n e e d f or oc ul ar s ur g er y  wit hi n o n e y e ar i n t h e st u dy ey e .  
6.  R e q uir e m e nt of a c o m bi n e d gl a uc o m a pr oc e d ur e i n t h e st u dy e y e.  
7.  C o nt act l e ns us e i n t h e st u dy ey e . 
8.  Cli nic all y si g nific a nt i nfl a m m ati o n or i nf ecti o n i n t h e st u dy ey e wit hi n 6 0 d ays pri or t o t h e 
pr e o p er ati v e visit ( e. g., bl e p h aritis, c o nj u ncti vitis, k er atitis, uv eitis, h er p es si m pl ex i nf ecti o n) or a n y 
s yst e mic i nf ecti o n. F or p ur p os es of t his st u dy, cli nic ally si g nific a nt is c o nsi d er e d a ny s uc h c o n diti o n 
r e q uiri n g pr escri pti o n t h er a py.  
9.  Ot h er cli nic al c o n diti o ns:  
a.  P o orl y c o ntr oll e d di a b et es ( T y p e I or Ty p e II) as d et er mi n e d  by H b A 1c > 8 . 
b.  C a nc er r e q uiri n g tr e at m e nt d uri n g t h e d ur ati o n of t h e st u dy.  
c. A ny dr u gs ( e. g.: i m m u n os u p pr essi v e dr u gs) or c o -m or bi dit y t h at mi g ht i n hi bit w o u n d 
h e ali n g .  
1 0.  P artici p ati o n i n a ny ot h er cli nic al tri al d uri n g p artici p ati o n i n t his tri al . 
1 1.  Lif e ex p ect a nc y < 1 y e ar.  
 
If b ot h ey es of a pr os p ecti v e tri al p artici p a nt ar e eli gi bl e, o nly t h e ey e wit h t h e hi g h est i ntr a-oc ul ar 
pr ess ur e will b e s el ect e d f or i m pl a nt.  ( N O T E: o nly o n e e y e p er s u bj ect m ay b e i m pl a nt e d wit h t h e 
i nv esti g ati o n al d evic e). 
 
5. 4  
P A TI E N T E N R O L L M E N T C A R D  
Aft er e nr olli n g i nt o t h e E arly Bir d st u dy a n d r ec eivi n g a B GI i m pl a nt , e ac h s u bj ect will b e iss u e d a P ati e nt 
C ar d. T his c ar d i d e ntifi es r ec ei pt  of t h e B GI a n d r ec o m m e n ds si g n s t o w atc h f or t h at s u g g est tr o u bl e or 
ris k t o t h e s u bj ect a n d r e q uir e p hysici a n f oll o w -u p. T h e c ar d als o pr o vi d es c o nt act i nf or m ati o n f or t h e 
s u bj ect a n d h e alt h c ar e pr ovi d ers.  
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 6  
Fi g ur e 6 : P ati e nt C ar d 
 
5. 5  
S T R A T E GI E S F O R R E C R U I T M E N T A N D R E T E N TI O N 
Pri or t o tri al r ecr uit m e nt, t h e S p o ns or  a n d i n v esti g ati o n al c e nt er s will d ev el o p st u dy st art -u p 
r ecr uit m e nt a n d r et e nti o n pr oc e d ur es t o d et er mi n e t actics t h at will b e e m pl o y e d t o r ecr uit a n d r et ai n 
st u dy s u bj ects. T actics m ay i ncl u d e S p o ns or -pr ovi d e d m at eri als f or pr os p ectiv e s u bj ects a n d sit e st aff, a 
c o m m u nic ati o n pl a n, mi ni m al l o n g -t er m d at a c oll ecti o n r e q uir e m e nts, a n d us e of p hysici a n r ef err al 
n et w or ks.  
 
5. 6  
P A R TI CI P A N T  WI T H D R A W A L  O R T E R MI N A TI O N  
 
5. 6 . 1 R E A S O N S F O R WI T H D R A W A L  O R T E R MI N A TI O N  
All s u bj ects e nr oll e d i n t h e cli nic al s t u dy, i ncl u di n g t h os e wit h dr a w n fr o m t h e cli nic al st u dy, t er mi n at e d, 
or l ost t o f oll o w -u p, s h all b e acc o u nt e d f or a n d d oc u m e nt e d. If a s u bj ect wit h dr a ws fr o m t h e cli nic al 
i nv esti g ati o n, t h e r e as o n(s) s h all b e r e p ort e d. R e as o ns f or wit h dr a w al m ay i ncl u d e, but ar e n ot li mit e d 
t o:   

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 7  
•  
S u bj ect f o u n d n ot t o m e et eli gi bilit y crit eri a  
•  
S u bj ect di d n ot r ec ei v e i m pl a nt   
•  
S u bj ect c h oic e t o wit h dr a w c o ns e nt  
•  
I nv esti g at or discr eti o n  
•  
L ost t o f oll o w-u p, d es pit e b est eff orts t o l oc at e t h e s u bj ect  
o  T hr e e d oc u m e nt e d att e m pts  t o c o nt act t h e s u bj ect, i ncl u di n g o n e c ertifi e d l ett er, ar e 
r e q uir e d t o d ecl ar e a s u bj ect l ost t o f oll o w u p.  
•  
D e at h (s e e S ecti o n 8. 6  f or r e p orti n g r e q uir e m e nts). 
If a s u bj ect wit h dr a ws fr o m t h e cli nic al i n v esti g ati o n, t h e r e as o n(s) s h all b e r e p ort e d o n t he E n d of St u dy 
el ectr o nic c as e r e p ort f or m ( e C R F) i n t h e E D C s yst e m. D at a u p t o t h e p oi nt of wit h dr a w al will b e 
c oll ect e d. If a ny S A Es, S A D Es or U S A D Es ar e o p e n, ev er y eff ort s h o ul d b e m a d e t o f oll o w t h e s u bj ect 
u ntil r es ol uti o n. If t his is n ot p ossi bl e, a ny  o p e n ev e nt s h o ul d b e cl os e d or d oc u m e nt e d as c hr o nic. 
N or m al m a n uf act ur er vi gil a nc e m o nit ori n g of d evic e p erf or m a nc e will t a k e pl ac e aft er a s u bj ect is 
wit h dr a w n.  
5. 6 . 2 H A N D LI N G O F P A R TI CI P A N T  WI T H D R A W A L S O R T E R MI N A TI O N  
U p o n wit h dr a w al, t h e s u bj ect a n d p hysici a n m a y el ect t o h a v e a n i m pl a nt e d d e vic e ex pl a nt e d.  If t h e 
d e vic e is ex pl a nt e d, t h e s u bj ect s h o ul d c o nti n u e t o b e f oll o w e d at l e ast t hr o u g h 3 m o nt hs p ost -ex pl a nt 
or u ntil t h e w o u n d is h e al e d, w hic h ev er is l o n g er.  
5. 7  
P R E M A T U R E T E R MI N A TI O N O R S U S P E N SI O N O F S T U D Y  
I n t h e ev e nt of pr e m at ur e t er mi n ati o n or s us p e nsi o n of t h e st u dy, t h e S p o ns or  will pr o m ptl y n otify t h e 
i nv esti g ati o n al c e nt er a n d c o m m u nic at e a pl a n f or or d erl y t er mi n ati o n or s us p e nsi o n. El ecti v e ex pl a nts 
of i m pl a nt e d d e vic es s h all b e p erf or m e d u n d er t his pr ot oc ol, pri or t o st u dy cl os e -o ut.  
6  
S T U D Y D E VI C E  
 
6. 1  
S T U D Y D E VI C E D E S C RI P TI O N  
 
6. 1. 1  A C Q UI SI TI O N  
St u dy d e vic es will b e h a n d -d eli v er e d t o st u dy sit e by S p o ns or  p ers o n n el.  
6. 1. 2  A P P E A R A N C E, P A C K A GI N G, A N D L A B E LI N G  
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 8  
 
 
 
 
 
 
 
 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
1 9  
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2 2  
 
   
T o i m pl a nt t h e Br o w n gl a uc o m a I m pl a nt:  
S ur gic al Fi el d Pr e p ar ati o n  
All pr oc e d ur es will b e p erf or m e d usi n g as e ptic t ec h ni q u e.  
T h e aff ect e d e y e will b e i n di vi d u ally pr e p p e d wit h a li d/l as h scr u b usi n g 5 % p ovi d o n e -i o di n e s ol uti o n.  
T h e g o w n e d a n d gl o v e d s ur g e o ns/t ec hs will t h e n dr a p e t h e e y e wit h a s elf -a d h esiv e o p ht h al mic 
a p ert ur e dr a p e s uc h as t h e 3 M o p ht h al mic “ St eri -Dr a p e”.   
A n o p er ati n g micr osc o p e wit h p h ot o gr a p hic or di git al i m a gi n g r e q uir e d f or t h e i m pl a nt ati o n pr oc e d ur e 
is p ositi o n e d o v er t h e ey e.   
T est D e vic e I m pl a nt Pr oc e d ur e  
Pr e -i m pl a nt p h ot o micr o gr a p hs of t h e ey e will b e c oll ect e d.  T o pic al o p ht h al mic dr o ps of ofl ox aci n  or 
vi g a m ox , k et or ol ac a n d pr e d nis ol o n e will b e gi v e n t hr e e ti m es i n t h e i nt erv al b et w e e n s e d ati o n a n d 
c o m m e nc e m e nt of s ur g ery.  A li d s p ec ul u m is pl ac e d t o o p e n t h e oc ul ar fi el d.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2 3  
 
 
T h e fi n al i m pl a nt p ositi o n of t h e B GI s h o ul d b e vis u aliz e d micr osc o pic ally a n d v erifi e d b y g o ni osc o py.   
T h e a n gl e of i ns erti o n is r ec or d e d o n t h e i m pl a nt ati o n c as e r e p ort f or m.  P h ot o gr a p hs of t h e i m pl a nt will 
b e t a k e n t o d oc u m e nt p ositi o ni n g a n d l oc ati o n.  
6. 2  
D E VI C E DI S P O SI TI O N  P R O C E D U R E S  
D evic e acc o u nt a bilit y s h all b e i n c o m pli a nc e wit h I S O 1 4 1 5 5 a n d F D A r e g ul ati o ns.  
T h e S p o ns or  will c o ntr ol t h e a v ail a bility of all i nv esti g ati o n al d evic es b y h a n d -d eli v eri n g d evic es o nly t o 
tr ai n e d st u dy sit e p ers o n n el. T h e S p o ns or  s h all k e e p r ec or ds t o d oc u m e nt t h e p hysic al l oc ati o n of all 
i nv esti g ati o n al d evic es fr o m d eliv ery  of i nv esti g ati o n al d e vic es t o t h e i nv esti g ati o n sit e  u ntil r et ur n or 
dis p os al. D e vic es ar e n ot tr a nsf er a bl e b et w e e n I nv esti g at ors u nl ess pri or a p pr ov al is o bt ai n e d fr o m t h e 
S p o ns or . Acc ess t o i n v esti g ati o n al d evic es s h all b e c o ntr oll e d a n d t h e i nv esti g ati o n al d e vic es s h all be 
us e d o nl y i n t h e cli nic al i n v esti g ati o n a n d acc or di n g t o t h e Cli nic al I nv esti g ati o n Pl a n.  
T h e sit e Pri nci p al I nv esti g at or or a n a ut h oriz e d d esi g n e e s h all k e e p r ec or ds d oc u m e nti n g t h e r ec ei pt, 
us e, r et ur n a n d dis p os al of t h e i n v esti g ati o n al d evic es, w hic h s h all i ncl u d e :  
1. t h e d at e of r ec ei pt,  
2. i d e ntific ati o n of e ac h i nv esti g ati o n al d evic e ( b atc h n u m b er/s eri al n u m b er or u ni q u e c o d e),  
3. t h e ex pir y d at e,  
4. t h e d at e or d at es of us e,  
5. S u bj ect i d e ntific ati o n,  
6. d at e o n w hic h t h e i n v esti g ati o n al d e vic e w as r et ur n e d/ ex pl a nt e d fr o m t h e S u bj ect, if 
a p plic a bl e, a n d  
7. t h e d at e of r et ur n of u n us e d, ex pir e d or m alf u ncti o ni n g i n v esti g ati o n al d evic es, if a p plic a bl e.  
A n o ut -of -s ervic e pr o d uct is d efi n e d as a ny i m pl a nt a bl e pr o d ucts ( e. g. d evic e) r e m ov e d or r e n d er e d 
i n acti v e. O ut-of -s ervic e pr o d uct i ncl u d es b ut is n ot li mit e d t o d evic es t h at d o n ot f u ncti o n a p pr o pri at el y 
at i m pl a nt , a n d ex pl a nt e d pr o d uct. W h e n e v er p ossi bl e, a ny o ut -of -s ervic e pr o d uct s h o ul d b e r et ur n e d t o 
T his p orti o n is i m pl a nt e d i n 
t h e a nt eri or c h a m b er 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2 4  
t h e S p o ns or  f or a n alysis. I n t h e ev e nt of a S u bj ect d e at h, ev er y eff ort s h o ul d als o b e m a d e t o r et ur n 
ex pl a nt e d pr o d uct t o Micr o O ptx . 
7  
S T U D Y P R O C E D U R E S A N D  S C H E D U L E  
 
7 . 1 
S T U D Y P R O C E D U R E S/ E V A L U A TI O N S  
7. 1. 1  S T A N D A R D O F C A R E S T U D Y P R O C E D U R E S   
I nf or m e d c o ns e nt m ust b e o bt ai n e d fr o m e ac h s u bj ect pri or t o e nr oll m e nt i nt o t h e st u dy a n d pri or t o 
a ny st u dy -s p ecific pr oc e d ur es t h at ar e n ot p art of r o uti n e st a n d ar d of c ar e f or gl a uc o m a p ati e nts. T h e 
pr oc ess f or o bt ai ni n g i nf or m e d c o ns e nt s h all b e i n c o m pli a nc e wit h F D A r e g ul ati o ns ( 2 1 C F R 5 0) a n d I S O 
1 4 1 5 5.   
7. 1. 2 S T U D Y S P E CI FI C  P R O C E D U R E S   
S u bj ect c o nt act will b e acc or di n g t o t h e sc h e d ul e o utli n e d i n S ecti o n 7. 2. A ny u nsc h e d ul e d visits will b e 
r ec or d e d.  
N ot e: All d at a c oll ecti o n s h all b e d o n e as t h e first t hi n g i n t h e f oll o w u p visit, pri or t o a n y ot h er 
pr oc e d ur es.  
N ot e: A dv ers e ev e nt d at a will b e c oll ect e d at e ac h visit aft er t h e Scr e e ni n g/ B as eli n e Visit.  
 
7. 1. 3  O P H T H A L MI C E X A MI N A TI O N S   
All p ati e nts  wil l r ec ei v e p eri o dic o p ht h al mic ex a mi n ati o ns i ncl u di n g slit l a m p ev al u ati o ns, i n dir ect 
o p ht h al mic ex a mi n ati o ns a n d i ntr a oc ul ar pr ess ur e t o n o m etry m e as ur e m e nts . E ac h e y e will b e ex a mi n e d 
a n d p h ot o gr a p hs t a k e n of t h e i m pl a nt e d t est d evic e . Pre -i m pl a nt p h ot o gr ap hs will b e c oll ect e d o n t h e 
d a y of ( b ut pri or t o) i m pl a nt . 
T h e p u pil of e ac h e y e m ust b e s uffici e ntly dil at e d t o all o w i n dir ect o p ht h al mic ev al u ati o ns. T o pic al 
m y dri atics ( Tr o pic a ni mi d e a n d P h e n yl e p hri n e, or e q uiv al e nt) m ay b e us e d t o ac hi e v e t his if n e e d e d 
b as e d u p o n pr ef er e nc es of t h e ex a mi n er. T h e o p ht h al mic ex a mi n ati o ns will b e r ec or d e d o n t h e 
a p pr o pri at e c as e r e p ort f or ms. 
T h e o p ht h al mic ex a mi n ati o ns will i ncl u d e: 
•  
B est C orr ect e d Vis u al Ac uity  
•  
A p pl a n ati o n T o n o m etr y  
•  
B o dy T e m p er at ur e  
•  
C e ntr al C or n e al T hic k n ess 
•  
Slit L a m p Ex a mi n ati o n  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2 5  
•  
I n dir ect O p ht h al mic Ex a mi n ati o n wit h dil ati o n 
•  
V ertic al C/ D r ati o  
•  
C or n e al E n d ot h eli al C ell C o u nt  
•  
G o ni osc o py  
•  
O ptic N erv e I m a g e A n al ysis  
•  
P eri m etr y  
•  
S ei d el’s T est  
•  
Sc hir m er T e ar T est  
•  
Le ns st at us f or p h a kic ey es  
•  
Tr e at m e nt  S atisf acti o n Q u esti o n n air e  
•  
I m pl a nt P h ot o micr o gr a p h 
7. 1. 3. 1  
B E S T C O R R E C T E D VI S U A L A C UI T Y  
B est C orr ect e d Vis u al Ac uity is p erf or m e d t o a st a n d ar d E arl y Tr e at m e nt Di a b etic R eti n o p at h y St u dy 
(E T D R S) t esti n g pr ot oc ol , a n d r e q uir es a d e dic at e d 4 m e t er dist a nc e f ull r es e arc h l a n e a n d E T D R S 
E q ui p m e nt f or vis u al ac uit y st a n d ar d pr ot oc ol.  
I n t his t est, t h e f oll o wi n g m e as ur es ar e m a d e i n b ot h t h e t est a n d c o ntr al at er al ey es: 
•  
U nc orr ect e d Vis u al Ac uit y ( U C V A)  
•  
Pr es e nt Gl ass es V is u al Ac uit y ( P G V A) 
•  
M a nif est R efr acti o n  
L o g M A R is c alc ul at e d f or e ac h acc or di n g t h e t h e c alc ul ati o n:  
L o g M A R V A = 0. 1 + L o g M A R v al u e of t h e b est li n e r e a d –  0. 0 2 X ( n u m b er of l ett ers r e a d) . 
T o c o nfir m t h at t h e st u dy s u bj ect p erc ei v es n o li g ht i n t h e st u dy e y e, c o m pl et el y occl u d e or c ov er 
t h e f ell o w e y e t o pr e v e nt li g ht sc att er t h at mi g ht b e p erc eiv e d b y t h e n o n-st u dy e y e.  Usi n g a bri g ht, 
n arr o w b e a m e d li g ht s o urc e s uc h as a Fi n h off m uscl e li g ht or i n dir ect o p ht h al m osc o p e, s hi n e t h e 
li g ht i n t h e st u dy ey e a nd q u esti o n t h e s u bj ect o n w h et h er or n ot li g ht is p erc eiv e d.  R e p e at t his t est, 
wit h li g ht o n a n d off, at l e ast 1 0 ti m es.  
7. 1. 3. 2  
A P P L A N A TI O N T O N O M E T R Y  
I ntr a oc ul ar pr ess ur es (I O Ps) of t h e t est a n d c o ntr ol e y es ar e m e as ur e d wit h a G ol d m a n A p pl a n at or 
acc or di n g t o t h e G ol d m a n m et h o d. T w o m e as ur es ar e t a k e n fr o m e ac h ey e a n d t h e a v er a g e is 
c alc ul at e d. Di ur n al I O Ps m ay b e c oll ect e d , as d escri b e d a b o v e , f or t hre e m e as ur e m e nts t a k e n f o ur 
h o urs a p art, a n d r ec or d e d i n a 2 4 h o ur cl oc k f or m at. 
7. 1. 3. 3  
B O D Y T E M P E R A T U R E  
B o dy t e m p er at ur e is r ec or d e d i n d e gr e es f a hr e n h eit at e ac h f oll o w -u p.  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2 6  
7. 1. 3. 4  
C E N T R A L C O R N E A L T HI C K N E S S  
C e ntr al c or n e al t hic k n ess is m e as ur e d i n b ot h ey es usi n g a n ultr as o u n d p ac hy m et er. T hr e e 
m e as ur e m e nts  ar e m a d e a n d a v er a g e d f or b ot h t h e t est a n d c o ntr al at er al e y e.  
7. 1. 3. 5  
G E N E R A L E X T E R N A L O H P T H A L MI C E X A M  
T h e t est a n d c o ntr ol e y es will b e ex a mi n e d wit h s p eci al att e nti o n t o t h e f oll o wi n g p ar a m et ers:  
•  E v al u ati o n of t h e c or n e a  
•  E v al u ati o n of t h e  t est ey e d e vic e a n d w h et et h er it is visi bl e or h e al e d ov er  
•  E v al u ati o n of p eri orit al ski n  
•  E v al u ati o n of t h e e y e li ds  
o  T h e li ds  a n d m ar gi ns  will b e ex a mi n e d f or er y t h e m a a n d f or e d e m a. 
o  T o d escri b e er yt h e m a t h e f oll o wi n g sc al e is us e d:  
□ 0 = N or m al  
□ 1 = Mil d (r e d n ess l oc aliz e d t o s m all r e gi o n of t h e li ds m ar gi n or ski n)  
□ 2 = M o d er at e (r e d n ess of m ost or all li d m ar gi n or ski n)  
□ 3 = S ev er e (r e d n ess of m ost or all li d m ar gi n a n d s ki n)  
□ 4 = V ery S e v er e ( m ark e d diff us e r e d n ess of b ot h li d m ar gi n A N D s ki n)  
o  T o d escri b e e d e m a t h e f oll o wi n g sc al e is us e d:  
□ 0 = N or m al  
□ 1 = Mil d (l oc aliz e d t o s m all r e gi o n of t h e li d)  
□ 2 = M o d er at e ( diff us e, m ost or all li d b ut n ot pr o mi n e nt / p r otr u di n g) 
□ 3 = S ev er e ( diff us e, m ost or all li d a n d pr o mi n e nt/ pr otr u di n g)  
□ 4 = V ery S e v er e ( diff us e A N D pr o mi n e nt/ pr otr u di n g A N D r ev ersi o n of t h e 
li d)  
•  E v al u ati o n of t h e c o nj u nctiv a  
o  T h e c o nj u ncti v a will b e ex a mi n e d f or eryt h e m a a n d f or e d e m a.  
o  T o d escri b e er yt h e m a t h e f oll o wi n g sc al e is us e d:  
□ 0 = N o n e ( n or m al)  
□ 1 = Mil d ( a fl us h r e d dis h c ol or)  
□ 2 = M o d er at e ( m or e pr o mi n e nt r e d c ol or)  
□ 3 = S ev er e ( d efi nit e r e d n ess)  
o  T o d escri b e e d e m a t h e f oll o wi n g sc al e is us e d:  
□ 0 = N o n e ( n or m al)  
□ 1 = Mil d (sli g ht l oc aliz e d s w elli n g) 
□ 2 = M o d er at e ( m o d er at e m e di u m l oc aliz e d s w elli n g or mil d diff us e 
s w elli n g) 
□ 3 = S ev er e (s e v er e diff us e s w elli n g)  
□ 4 = V ery S e v er e (v ery pr o mi n e nt / pr otr u di n g diff us e s w elli n g)  
•  E v al u ati o n of t h e scl er a  
o  T h e Scl er a will b e ex a mi n e d f or er yt h e m a.  
o  T o d escri b e er yt h e m a t h e f oll o wi n g sc al e is us e d:  
□ 0 = N o n e ( n or m al)  
□ 1 = Mil d ( a fl us h r e d dis h c ol or)  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2 7  
□ 2 = M o d er at e ( m or e pr o mi n e nt r e d c ol or)  
□ 3 = S ev er e ( d efi nit e r e d n ess) . 
7. 1. 3. 6  
S LI T L A M P O P H T H A L MI C  E X A MI N A TI O N S  
T h e slit l a m p o p ht h al mic ev al u ati o ns will i ncl u d e ass ess m e nt of: 
•  St at us of t h e i m pl a nt e d d evic e  
•  E v al u ati o n of t h e e y e b ei n g n or m al or i nf ect e d  
•  E v al u a ti o n of t h e c or n e a 
•  E v al u ati o n of t h e a nt eri or c h a m b er  
•  E v al u ati o n of t h e iris 
•  E v al u ati o n of t h e l e ns  
•  C or n e al s urf ac e  st ai ni n g 
•  C o nj u ncti v al eryt h e m a  
•  M e as ur e m e nt of V ertic al C/ D r ati o  
 
T h e c or n e a will b e e v al u at e d a n d o bj ecti v el y sc or e d acc or di n g t o t h e sc al es d ev el o p e d bt H ac k ett 
a n d Mc D o n al d 1.  T h es e sc ori n g crit eri a ar e as f oll o ws: 
C or n e al E x a m Fi n di n gs Sc or e  
0 -N or m al c or n e a. A p p e ars wit h t h e slit -l a m p a dj ust e d t o a n arr o w slit i m a g e as h a vi n g a bri g ht gr a y li n e 
o n t h e e pit h eli al s urf ac e a n d a bri g ht gr a y li n e o n t h e e n d ot h eli al s urf ac e wit h a m ar bl e -li k e gr a y 
a p p e ar a nc e of t h e str o m a.  
1 - S o m e l oss of tr a ns p ar e nc y. O nl y t h e a nt eri or h alf of t h e str o m a is i n v ol v e d as o bs er v e d wit h a n o ptic al 
s ecti o n of t h e slit-l a m p. T h e u n d erl yi n g str uct ur es ar e cl e arl y visi bl e wit h diff us e ill u mi n ati o n, alt h o u g h 
s o m e cl o u di n ess c a n b e r e a dil y a p p ar e nt wit h diff us e ill u mi n ati o n. 
2 -M o d er at e l oss of tr a ns p ar e nc y. I n a d diti o n t o i n v ol vi n g t h e a nt eri or str o m a, t h e cl o u di n ess ext e n ds all 
t h e w a y t o t h e e n d ot h eli u m. T h e str o m a h as l ost its m ar bl e-li k e a p p e ar a nc e a n d is h o m o g e n o usl y w hit e. 
Wit h diff us e ill u mi n at i o n, u n d erl yi n g str uct ur es ar e cl e arl y visi bl e. 
3 - I n v ol ve me nt of t he e ntire t hic k ness of t he str o m a wit h e n d ot heli u m i nt act.  Wit h o ptical secti o n, t he 
e n d ot helial s urface is still visi ble. H o we ver, wit h diff use ill u mi nati o n t he u n derl yi n g str uct ures are j ust 
barel y visi ble (t o t he e xte nt t hat t he o bser ver is still a ble t o gra de flare a n d iritis, o bser ve f or p u pillar y 
res p o nse, a n d n ote le ntic ular c ha n ges). 
4 - I n v ol v e m e nt of t h e e ntir e t hic k n ess of t h e str o m a wit h e n d ot h eli u m d a m a g e d. Wit h t h e o ptic al 
s ectio n, c a n n ot cl e arl y vis u aliz e t h e e n d ot h eli u m. Wit h diff us e ill u mi n ati o n, t h e u n d erl yi n g str uct ur es 
c a n n ot b e s e e n. Cl o u di n ess r e m o v es t h e c a p a bilit y f or j u d gi n g a n d gr a di n g fl ar e, iritis, l e ntic ul ar c h a n g es, 
a n d p u pill ar y r es p o ns e.  
 
 
                                                                
 
1  H a c k ett R B, M c D o n al d T O. 1 9 9 1. E y e irrit ati o n. I n: A d v a n c e s i n M o d er n T o xi c ol o g y: D er m at o xi c ol o g y. 
4t h e d. ( M ar z ulli F, M ai b a c h H, e d s.). W a s hi n gt o n, D C: H e mi s p h er e P u bli s hi n g C or p or ati o n, 7 4 9 – 8 1 5  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2 8  
C or n e al O p acit y Ar e a S c or e 
0 - N or m al c or n e a wit h n o ar e a of cl o u di n ess  
1 - 1 % t o 2 5 % ar e a of str o m al cl o u di n ess  
2 - 2 6 % t o 5 0 % area of str o mal cl o u di ness  
3 - 5 1 % t o 7 5 % ar e a of str o m al cl o u di n ess  
4 - 7 6 % t o 1 0 0 % ar e a of str o m al cl o u di n ess  
T h e l e n s will b e e v al u at e d a n d  o bj e cti v el y s c or e d a c c or di n g t o  a m o difi e d  m et h o d ol o g y  
pr e vi o u sl y d e s cri b e d b y C hl a c k, et. Al i n t h e L O C S III m et h o d 2 .  T h e f oll o wi n g a s s e s s m e nt s 
will b e p erf or m e d u si n g a d e ci m ali z e d s c al e r a n gi n g fr o m 0 (i n di c ati n g a c o m pl et el y cl e ar or 
c ol orl e s s l e n s) t o 5 (i n di c ati n g c o m pl et e o p a cifi c ati o n o n t h e c ort e x or p o st eri or c a p s ul e f or 
C or P s c al e s) a n d 5 i n di c ati n g a d v a n c e d o p a cifi c ati o n a n d br u n e s c e n c e of t h e n u cl e u s f or 
N O or N C s c al e s). E a c h a s s e s s m e nt will b e r e c or d e d t o t h e n e ar e st si n gl e di git a s 
d et er mi n e d b y t h e o p ht h al m ol o gi st.  
T a bl e 1  M o difi e d L O C S Sc ori n g  
N uclear C ol or      ☐ 0  ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5  
☐ 0  ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5  
N uclear o palesce nce  ☐ 0  ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5  
☐ 0  ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5  
C ortical  ☐ 0  ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5  
☐ 0  ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5  
P osteri or Ca ps ular  ☐ 0  ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5  
☐ 0  ☐ 1  ☐ 2  ☐ 3  ☐ 4  ☐ 5  
 
 
 
                                                                
 
2 C h yl ac k,L. T; et. al; T h e L e ns O p aciti es Cl assific ati o n S yst e m III, Arc h. O p ht h al m ol.; v ol 1 1 1, 
8 3 1 -8 3 6, 1 9 9 3  
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
2 9  
T h e exist e nc e or a bs e nc e of uv eitis will b e d oc u m e nt e d usi n g st a n d ar diz e d u v eitis n o m e ncl at ur e 
as r e p ort e d by J a bs 6 et. A l. If uv eitis exists, it will b e cl assifi e d as f oll o ws: 
 
T a bl e 2  J a b U v eitis Sc ori n g 
•  A nt eri or U v eitis  
o  Gr a d e  
 
 
C ells i n fi el d  
o  0  
 
 
 
< 1  
o  0. 5 +  
 
 
1 -5  
o  1 +   
 
 
6 -1 5  
o  2 +   
 
 
1 6 -2 5  
o  3 +   
 
 
2 6 -5 0  
o  4 +   
 
 
> 5 0  
•  A nt eri or C h a m b er Fl ar e  
o  Gr a d e  
 
 
D escri pti o n  
o  0  
 
 
 
n o n e  
o  1 +   
 
 
f ai nt 
o  2 +   
 
m o d er at e (iris a n d l e ns d et ail cl e ar)  
o  3 +   
 
m ar k e d (iris a n d l e ns d et ail f uzzy)  
o  4 +   
 
i nt e ns e ( fi bri n or pl astic a q u e o us) 
•  I nt er m e di at e U v eitis 
o  Gr a d e  
 
 
D escri pti o n  
o  1 +   
 
 
f ai nt 
o  2 +   
 
 
mil d  
o  3 +   
 
 
m o d er at e  
o  4 +   
 
 
s e v er e 
•  P ost eri or U v eitis  
o  Gr a d e  
 
 
D escri pti o n  
o  1 +   
 
 
f ai nt 
o  2 +   
 
 
mil d  
o  3 +   
 
 
m o d er at e  
o  4 +   
 
 
s e v er e 
•  P a n u v eitis  
o  Gr a d e  
 
 
D escri pti o n  
o  1 +   
 
 
f ai nt 
o  2 +   
 
 
mil d  
o  3 +   
 
 
m o d er at e  
o  4 +   
 
 
s e v er e 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 0  
7. 1. 3. 7  
V E R TI C L E C/ D  R A TI O  
T h e v ertic al a n d h oriz o nt al C/ D r ati o will b e ass ess e d utilizi n g a 9 0 di o pt er l e ns d uri n g t h e slit l a m p 
ex a mi n ati o n .      
7. 1. 3. 8  
I N DI R E C T O P H T H A L MI C E X A MI N A TI O N S  
T h e i n dir ect o p ht h al mic e v al u ati o ns of b ot h t h e t est a n d c o ntr al at er al e y es will i ncl u d e ass ess m e nt 
of:  
•  
E v al u ati o n of t h e iris 
•  
E v al u ati o n of t h e r eti n a  
•  
E v al u ati o n of t h e v itr e o us 
•  
E v al u ati o n of t h e o ptic cu p a n d d isc 
•  
E v al u ati o n of t h e m ac ul a  
 
R es ults of e ac h of t h es e ex a mi n ati o ns will b e sc or e d o n t h e f oll o wi n g sc al e f or b ot h t h e t est a n d 
c o ntr al at er al e y es. 
□ N or m al  
□ A b n or m al N C S  –  N ot Cli nic ally Si g nific a nt  
□ A b n or m al C S  –  Cli nic ally Si g nific a nt  
 
7. 1. 3. 9  
C O R N E A L E N D O T H E LI A L C E L L C O U N T  
T h e c or n e al e n d ot h eli al c ell c o u nt will b e ass ess e d f or b ot h t h e t est a n d c o ntr al at er al ey e utilizi n g 
S p ec ul ar Micr osc o py. T h e r es ult will b e ex pr ess e d as c ells/ m m 2. 
T o a d dr ess diff er e nc es i n l oc ati o n of t h e i m a g e wit hi n a giv e n ar e a of t h e c or n e a, t hr e e 
acc e pt a bl e i m a g es  s h o ul d b e t a k e n at e ac h visit. T h e d e nsit y fr o m at l e ast o n e pr ef err e d i m a g e 
s h o ul d b e d et er mi n e d.  
N o n -c o nt act s p ec ul ar micr osc o p es ar e str o n gl y r ec o m m e n d e d. T h e s a m e m o d el of s p ec ul ar 
micr osc o p e s h o ul d b e us e d at e ac h sit e. I m a g es s h o ul d b e st or e d o n 3 5  m m sli d es, h alf -i nc h 
vi d e o, or i n el ectr o nic f or m at. S p ec ul ar c a m er as t h at c a n r ec or d di gitiz e d i m a g es o n dis k or t o e -
m ail ar e pr ef er a bl e f or e as e of d at a tr a nsf er.   
T o c a pt ur e a g o o d i m a g e:  
•  
m a k e s ur e t h e s u bj ect is c o mf ort a bl e;  
•  
i nstr uct t h e s u bj ect to bli n k;  
•  
i nstr uct t h e s u bj ect n ot t o m ov e a n d t o o p e n ey es wi d e;  
•  
i nstr uct t h e s u bj ect t o f oc us o n t h e fix ati o n li g ht; a n d, 
•  
if n ec ess ar y, us e t h e m a n u al s etti n g. ( N ot e t h at t h e us e of t h e m a n u al s etti n g m ay 
r e q uir e a d diti o n al tr ai ni n g.)  
  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 1  
T h e t ec h nici a n p erf or mi n g t h e i m a g e a n alysis s h o ul d b e a dvis e d of t h e f oll o wi n g 
r ec o m m e n d ati o ns:  
•  
A mi ni m u m of 1 0 0 c ells (i d e all y 1 5 0 c ells)  i n a c o nti g u o us ar e a s h o ul d b e c o u nt e d. T h e 
c e nt er m et h o d f or c o u nti n g c ells is r ec o m m e n d e d;  
•  
T h e q u alit y of c ells i n a n i m a g e is critic al. W h e n s el ecti n g c ells t o c o u nt, us e t h e ar e a wit h 
t h e f e w est dist orti o ns ( n ot i n s h a d o w, w as h e d-o ut, or bl urr e d).  
•  
F o ll o w t h e s a m e m et h o d ol o gy f or all s u bj ects at all visits. 
7. 1. 3. 1 0  G O NI O S C O P Y  
G o ni osc o py ev al u ati o ns will b e p erf or m e d o n b ot h t h e t est a n d c o ntr al at er al ey es. T h e f oll o wi n g 
p ositi o ns o n t h e a nt eri or a n gl es will b e ass ess e d: s u p ert e m p or al, s u p er o n as al, i nf er ot e m p or al, 
a n d i nf er o n as al . T h e r es ults will b e sc or e d b as e d o n t h e S h aff er Cl assific ati o n:  
Gr a d e 4 : T h e a n gl e b et w e e n t h e iris a n d t h e s urf ac e of t h e tr a b ec ul ar m es h w ork is 4 5°. 
Gr a d e 3 : T h e a n gl e b et w e e n t h e iris a n d t h e s urf ac e of t h e tr a b ec ul ar m es h w ork is gr e at er t h a n 
2 0° b ut l ess t h a n 4 5°.  
Gr a d e 2 : T h e a n gl e b et w e e n t h e iris a n d t h e s urf ac e of t h e tr a b ec ul ar m es h w ork is 2 0°. A n gl e 
cl os ur e is p ossi bl e. 
Gr a d e 1 : T h e a n gl e b et w e e n t h e iris a n d t h e s urf ac e of t h e tr a b ec ul ar m es h w ork is 10°. A n gl e 
cl os ur e is pr o b a bl e i n ti m e. 
Slit  ( S): T h e a n gl e b et w e e n t h e iris a n d t h e s urf ac e of t h e tr a b ec ul ar m es h w or k is l ess t h a n 1 0°. 
A n gl e cl os ur e is v ery li k el y.  
0 : T h e iris is a g ai nst t h e tr a b ec ul ar m es h w or k. A n gl e cl os ur e is pr es e nt. 
7. 1. 3. 1 1  O P TI C N E R V E  I M A G E A N A L Y SI S 
T h e o ptic n erv es of b ot h t h e t est a n d c o ntr al at er al e y es will b e i m a g e d a n d a n alyz e d b y O ptic al 
C o h er e nc e T o m o gr a p hy ( O C T). T h e f oll o wi n g p ar a m et ers will b e m e as ur e d:  
•  
V ertic al Disc Di a m et er  
•  
V ertic al C u p Di a m et er  
•  
S u p eri or r eti n al N erv e Fi b er L a y er (r N FL) 
•  
I nf eri or r eti n al N erv e Fi b er L a y er (r N FL) 
•  
T e m p or al r eti n al N erv e Fi b er L ay er (r N FL)  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 2  
7. 1. 3. 1 2  P E RI M E T R Y  
T h e vis u al p eri m etry of t h e c o ntr al at er al n o n -i m pl a nt e d e y es will b e ass ess e d utilizi n g a ut o m at e d 
H u m p hr e y Vis u al Fi el d ( H VF) t esti n g. F or t his t esti n g t h e e y e s h o ul d n ot b e dil at e d ul ess it is mi otic 
(t h e p u pil is < 3 m m o p e n). Wit h I nv esti g at or a p pr o v al, t h e ey e m ay b e dil at e d, h o w e v er all 
r e m ai ni n g H V F f oll o w-u p ev al u ati o ns  of t h at e y e s h o ul d als o b e dil at e d. F or t h e HF V t esti n g t h e 
st a n d ar d S w e dis h I nt er activ e T hr es h ol di n g Al g orit h m ( SI T A) t esti n g al g orit h m s h o ul d b e us e d. +/ 1 
m e a n d e vi ati o ns will b e r e p ort e d.  
7. 1. 3. 1 3  F L U O R E S C EI N  S T AI N I NG  
T h e s urf ac e a n d c or n e as of b ot h t h e t est a n d c o ntr al at er al ey es will b e st ai n e d wit h fl u or esc ei n a n d 
t h e s urf ac es ex a mi n e d b y fl u or esci e nt li g ht e v al u ati o n. T h e ev al u ati o n s h o ul d b e p erf or m e d 
a p pr oxi m at ely 2. 5 mi n ut es aft er fl u or esc ei n i nstill ati o n i n t h e ey e. T h e p hysici a n s h o ul d us e br o a d 
b e a m c o b alt bl u e ill u mi n ati o n a n d a y ell o w b arri er filt er h a n d h el d i n fr o nt of t h e o bj ecti v e t o 
o bs erv e c or n e al st ai ni n g.  
B as e d u p o n t h e ev al u ati o ns, t h e fiv e r e gi o ns of t h e c or n e a will b e sc or e d ( 0 -3) as s h o w n b el o w:  
Fi g ur e 1 2  C or n e al Fl u or esc ei n Sc ori n g  
 
 
 
7. 1. 3. 1 4  S EI D E L’ S T E S TI N G  
T o pic al fl u or esc ei n will b e a p pli e d t o t h e cr oss b ar t a b of e ac h t est d e vic e p ost -i m pl a nt at e ac h 
f oll o w-u p ex a m a n d o bs er v e d u n d er m a g nific ati o n t o ass ess d e vic e p at e nc y (c e ntr al fl o w) a n d 
p eri p h er al fl o w.  Ty pic ally, t his is acc o m plis h e d b y w etti n g t h e s t eril e fl u or esc ei n stri p wit h st eril e 
o p ht h al mic t o pic al a n est h etic a g e nt a n d t o uc hi n g t h e p a p er fl u or esc ei n a p plic at or t o t h e cr oss b ar 
t a b a n d vici nity of t h e i m pl a nt sit e. Pr o p er a q u e o us fl o w fr o m t h e c e nt er of t h e cr oss b ar t a b 
(ce ntr al fl o w) m a y b e v e rifi e d dir ectly u n d er m a g nific ati o n a n d wit h o ut fl u or esc e nt l a m p 
ill u mi n ati o n.  Fl u or esc e nt ill u mi n ati o n wit h c o b alt bl u e l a m p ill u mi n ati o n fr o m t h e slit l a m p or 
ot h er c o b alt bl u e li g ht s o urc es m a y e n h a nc e vis u aliz ati o n of exiti n g a q u e o us h u m or.  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 4  
7. 1. 3. 1 5  S C HI R M E R T E A R T E S T  
A st a n d ar d Sc hir m er t e ar t est will b e p erf or m e d i n b ot h t h e t est a n d c o ntr al at er al e y e t o ass ess 
t e ar pr o d ucti o n st at us. T h e m e as ur e m e nt i nt erv al will b e 5-mi n ut es d ur ati o n.  
7. 1. 3. 1 6  L E N S S T A T U S  F O R P H A KI C E Y E S  
T h e l e ns st at us f or p h akic ey es will b e d escri b e d f or b ot h t h e t est a n d c o ntr al at er al e y e if 
a p plic a bl e.  
 
A m o difi e d  L O C S III gr a di n g s yst e m  utilizi n g a 0 -5 si n gl e di git sc ori n g s yst e m  will  b e us e d t o 
e v al u at e all e y es f or l e ns c h a n g es a n d t o ev al u at e t h os e c h a n g es ov er ti m e .  St a n d ar diz e d 
d efi niti o ns i n t his i nstr u m e nt will b e us e d t o d et er mi n e  “c h a n g e”.   
7. 1. 3. 1 7  T R E A T M E N T S A TI S F A C T I O N Q U E S TI O NN AI R E  
T h e m o difi e d Tr e at m e nt S atisf acti o n Q u esti o n n air e ( T S Q) will b e gi v e n t o t h e p ati e nt at t h e 
b e gi n ni n g of t h e f oll o w -u p visit a n d pri or t o i niti ati o n of t esti n g pr oc e d ur es. T h e c o or di n at or s h o ul d 
at t e m pt t o a d mi nist er t h e q u esti o n n air e i n a c o nsist e nt f as hi o n. 
 
T his q u esti o n n air e will att e m pt t o m e as ur e t h e st u dy s u bj ect’s ov er all s atisf acti o n wit h t h e 
i m pl a nt e d d evic e a n d pr oc e d ur e. D at a will b e s u m m ariz e d usi n g si m pl e, d escri pti v e fr e q u e nc y 
t a bl es. 
 
7. 1. 3. 1 8  S Y M P T O M A N D  H E A L T H P R O B L E M C H A R T F R O M CI G T S  
T h e S y m pt o m a n d H e alt h Pr o bl e m C h art fr o m t h e C oll a b or ativ e I niti al Gl a uc o m a Tr e at m e nt St u dy 
( CI G T S)3 will b e giv e n t o t h e p ati e nt at t h e b e gi n ni n g of t h e f oll o w -u p visit a n d pri or t o i niti ati o n of 
t esti n g pr oc e d ur es. T h e c o or di n at or s h o ul d att e m pt t o a d mi nist er t h e q u esti o n n air e i n a c o nsist e nt 
f as hi o n. 
C urr e ntl y p er missi o n t o utiliz e t h e s urv ey is n ot y et s ec ur e d fr o m t h e CI G T S A ut h ors.  T h e 
i nstr u m e nt will b e a d mi nist er e d o nc e p er missi o n is s ec ur e d pr os p ecti v el y o nl y.  
 
 
 
 
 
                                                                
 
3  J a n z, J. K; et. al. Q u alit y of Lif e i n N e wl y Di a g n o s e d Gl a u c o m a P ati e nt s; O p ht h al m ol o g y V ol u m e 1 0 8, 
N u m b er 5, M a y 2 0 0 1  
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 5  
7. 2  
S T U D Y S C H E D U L E  
 
7. 2. 1  S C R E E NI N G / B A S E LI N E  
S u bj ects will b e pr o vi d e d wit h t h e S u bj ect I nf or m ati o n a n d I nf or m e d C o ns e nt F or m w hic h a d vis es t h at 
d at a will b e c oll ect e d f or ev al u ati o n of eli gi bilit y f or i ncl usi o n i n t h e Tri al. S u bj ects ar e t ol d t h at if t h e 
crit eri a ar e m et a n d t h e su bj ect c o ns e nts, t h e n t h e Br o w n Gl a uc o m a I m pl a nt will b e i m pl a nt e d. If t h e 
su bj ect a gr e es t o i ncl usi o n f or d at a c oll ecti o n, t h e su bj ect I nf or m e d C o ns e nt will b e si g n e d a n d r ec or d e d 
i n t h e su bj ect’s r ec or ds as p art of  t h e Scr e e ni n g/ B as eli n e visit. T h e su bj ect will b e assi g n e d a u ni q u e 
st u dy i d e ntifi er.  
T h e Scr e e ni n g/ B as eli n e ev al u ati o n m a y b e c o m pl et e d aft er t h e p ati e nt h as r e vi e w e d, u n d erst o o d, a n d 
si g n e d t h e I nf or m e d C o ns e nt. T h e B as eli n e ass ess m e nt s m a y b e p erf or m e d at a ny ti m e pri or t o t h e 
I m pl a nt visit. If t h e i m pl a nti n g p hysici a n d et er mi n es t h at t he s u bj ect is n ot a s uit a bl e c a n di d at e f or t h e 
pr oc e d ur e, t h e n t h e s u bj ect s h all n ot b e sc h e d ul e d f or i m pl a nt, will b e wit h dr a w n fr o m t h e tri al, a n d will 
n ot b e i ncl u d e d i n t h e a n alysis . 
D at a t o b e c oll ect e d d uri n g t h e Scr e e ni n g/ B as eli n e visit i ncl u d e:  
•  
I nfor m e d C o ns e nt F or m  
•  
D oc u m e nt ati o n of eli gi bility   
•  
M e dic al Hist ory (i ncl u di n g P hysic al Ex a m)  
•  
M e dic ati o ns ( all m e dic ati o ns i ncl u di n g i n dic ati o n)  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
C e ntr al c or n e al t hic k n ess  
•  
Di ur n al I O P ass ess m e nt  
•  
G o ni osc o py  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h al mic ex a mi n ati o n wit h dil ate d f u n d us ex a m  
•  
V ertic al C/ D r ati o ass ess m e nt  
•  
C or n e al s urf ac e st ai n  
•  
O ptic n erv e i m a g e a n alysis  
•  
C or n e al e n d ot h eli al c ell c o u nt  (s p ec ul ar micr osc o py) 
•  
P eri m etr y  of n o n i m pl a nt e d e y e  
•  
L e ns st at us f or p h a kic ey es 
•  
Sc hir m er ’s T e ar T est 
•  
P ati e nt b o dy t e m p er at ur e 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 6  
Activiti es t o b e p erf or m e d:  
•  
A ns w er a ny q u esti o ns t h e su bj ect m a y h a v e, a n d c o nfir m willi n g n ess t o pr oc e e d if t h e b as eli n e 
crit eri a ar e v erifi e d.  
•  
V erify t h at t h e i ncl usi o n/ excl usi o n crit eri a ar e s atisfi e d.  
•  
Ass ess m e nt by t h e I nv esti g at or of t h e su bj ect’s s uit a bilit y f or B GI i m pl a nt ( e. g. m e nt al fit n ess).  
If t h e su b j ect m e ets t h e i ncl usi o n crit eri a, t h e s ur g ery f or t h e B GI  i m pl a nt will b e disc uss e d  wit h t h e 
su bj ect  a n d sc h e d ul e d . I nv esti g ati o n al st aff will ens ur e t h e pr o d uct a n d e q ui p m e nt  n ec ess ar y f or t h e 
pr oc e d ur e ar e  av ail a bl e, a n d sc h e d ul e s u p p ort st aff.  
7. 2 .2  I MP L A N T   
If I nf or m e d C o ns e nt is o bt ai n e d a n d eli gi bilit y h as b e e n p erf or m e d, t h e Im pl a nt visit s h o ul d b e 
sc h e d ul e d. T h e i m pl a nt s h o ul d occ ur as s o o n as p ossi bl e aft er b as eli n e d at a is c oll ect e d, a n d n ot m or e 
t h a n 3 0 d a ys aft er. B as eli n e d at a c oll ecti o n o n t h e d ay of s ur g ery is p er mitt e d, b ut m ust b e c oll ect e d 
pri or t o t h e s ur gic al pr oc e d ur e.  
D at a t o b e c oll ect e d at i m pl a nt i ncl u d e: 
•  
I m pl a nt l oc ati o n O S/ O D 
•  
P ati e nt b o dy t e m p er at ur e 
•  
Pr oc e d ur e E as e  
•  
Pr oc e d ur e st art a n d e n d ti m es  
•  
D escri pti o n of s ur gic al c h all e n g es 
•  
S ei d els T est  
•  
D evic e i nf or m ati o n  
•  
A dv ers e E v e nts  
•  
I m pl a nt sit e p h ot o 
•  
M e dic ati o n c h a n g es  
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 7  
 
7. 2 . 3 F O L L O W -U P  
P ost -i m pl a nt f oll o w-u p visits ( a n d c orr es p o n di n g visit wi n d o ws) will occ ur acc or di n g t o t h e f oll o wi n g 
sc h e d ul e: 
•  
D a y 1 ( o n e d a y)  
•  
W e ek 1 ( 5 -9 d ays)  
•  
W e ek 2 ( 1 1 -1 7  d ays)  
•  
M o nt h 1 ( 2 5 -3 5 d a ys)  
•  
M o nt h 2 ( 5 0 -7 0 d a ys)  
•  
M o nt h 3 ( 7 5 -1 0 5 d ays)  
•  
M o nt h 4. 5  ( 1 2 5-1 5 0 d ays)  
•  
M o nt h 6 ( 1 6 8 -1 9 6 d a ys)  
•  
M o nt h 8 ( 2 2 5 -2 5 5 d a ys)  
•  
M o nt h 1 0 ( 2 8 5 -3 1 5 d ays ) 
•  
M o nt h 1 2 ( 3 3 0 -3 9 0 d ays)  
•  
M o nt h 1 5( 4 4 0 -4 7 0 d ays)  
•  
M o nt h 1 8 ( 5 3 0-5 6 0 d ays)  
•  
M o nt h 2 1  ( 6 2 0-6 5 0 d ays)  
•  
M o nt h 2 4 ( 6 9 0 -7 5 0 d ays)  
D at a t o b e c oll ect e d at e ac h visit ar e s u m m ariz e d b el o w.  
D a y 1  
•  
A p pl a n ati o n t o n o m etr y  
•  
Slit l a m p ex a mi n ati o n  
•  
S ei d els T est  
•  
B o dy  t e m p er at ur e 
•  
I m pl a nt sit e p h ot o 
•  
A dv ers e ev e nts  
W e ek 1  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
Slit l a m p ex a mi n ati o n  
•  
S e i d el’s t est 
•  
B o dy  t e m p er at ur e 
•  
I m pl a nt Sit e p h ot o gr a p h 
•  
A dv ers e ev e nts  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 8  
W e ek 2  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h al mic ex a mi n ati o n  wit h dil at e d f u n d us ex a m  
•  
S e id el’s t est  
•  
B o dy  t e m p er at ur e 
•  
I m pl a nt sit e p h ot o gr a p h 
•  
A dv ers e ev e nts  
M o nt h 1  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h al mic ex a mi n ati o n wit h dil at e d f u n d us ex a m  
•  
S e id el’s t est  
•  
Sc hir m er T e ar T est  
•  
Tr e at m e nt S atisf acti o n Q u esti o n n air e ( T S Q)  
•  
L e ns St at us f or p h a kic l e ns es 
•  
B o dy t e m p er at ur e  
•  
I m pl a nt sit e p h ot o gr a p h  
•  
A dv ers e ev e nts  
M o nt h 2  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h al mic ex a mi n ati o n wit h dil at e d f u n d us ex a m 
•  
S e id el’s t est  
•  
B o dy t e m p er at ur e  
•  
I m pl a nt sit e p h ot o gr a p h  
•  
A dv ers e ev e nts  
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
3 9  
M o nt h 3  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h almic ex a mi n ati o n  wit h dil at e d f u n d us ex a m  
•  
C or n e al e n d ot h eli al c ell c o u nt (s p ec ul ar micr osc o py)  
•  
G o ni osc o py  
•  
S e id el’s t est  
•  
Sc hir m er T e ar T est  
•  
L e ns st at us f or p h a kic ey es 
•  
Tr e at m e nt S atisf acti o n Q u esti o n n air e ( T S Q)  
•  
B o dy t e m p er at ur e  
•  
I m pl a nt sit e p h ot o gr a p h  
•  
A dv ers e ev e nts  
M o nt h 4. 5  
•  
A p pl a n ati o n t o n o m etr y  
•  
D evic e sit e e v al u ati o n  
•  
S ei d el’s t est  
•  
I m pl a nt sit e p h ot o gr a p h 
•  
A dv ers e ev e nts  
M o nt h 6  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
C e ntr al c or n e al t hic k n ess  
•  
Di ur n al I O P ass ess m e nt  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h al mic ex a mi n ati o n wit h dil at e d f u n d us ex a m  
•  
V ertic al C/ D r ati o ass ess m e nt  
•  
C or n e al s urf ac e st ai n  
•  
C or n e al e n d ot h eli al c ell c o u nt  (s p ec ul ar micr osc o py) 
•  
G o ni osc o py  
•  
O ptic n erv e i m a g e a n alysis  
•  
P eri m etr y  of n o n i m pl a nt e d e y e  
•  
S e id el’s t est  
•  
Sc hir m er T e ar T est  
•  
L e ns st at us f or p h a kic ey es 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 0  
•  
Tr e at m e nt S atisf acti o n Q u esti o n n air e ( T S Q)  
•  
I m pl a nt sit e p h ot o gr a p h  
•  
B o dy t e m p er at ur e 
•  
A dv ers e ev e nts  
M o nt h 8  
•  
A p pl a n ati o n t o n o m etr y  
•  
D evic e sit e e v al u ati o n  
•  
S ei d el’s t est  
•  
I m pl a nt sit e p h ot o gr a p h 
•  
A dv ers e ev e nts  
M o nt h 1 0  
•  
A p pl a n ati o n t o n o m etr y  
•  
D evic e sit e e v al u ati o n  
•  
S ei d el’s t est  
•  
I m pl a nt sit e p h ot o gr a p h 
•  
A dv ers e ev e nts  
M o nt h 1 2  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
C e ntr al c or n e al t hic k n ess  
•  
Di ur n al I O P ass ess m e nt  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h al mic ex a mi n ati o n wit h dil at e d f u n d us ex a m 
•  
V ertic al C/ D r ati o ass ess m e nt  
•  
C or n e al s urf ac e st ai n  
•  
C or n e al e n d ot h eli al c ell c o u nt (s p ec ul ar micr osc o py)  
•  
G o ni osc o py  
•  
O ptic n erv e i m a g e a n alysis  
•  
P eri m etr y  of n o n i m pl a nt e d e y e  
•  
S ei d el’s t est  
•  
Sc hir m er T e ar T est  
•  
L e ns st at us f or p h a kic ey es 
•  
Tr e at m e nt S atisf acti o n Q u esti o n n air e ( T S Q)  
•  
I m pl a nt sit e p h ot o gr a p h 
•  
B o dy t e m p er at ur e  
•  
A dv ers e ev e nts  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 1  
 
M o nt h 1 5  
•  
A p pl a n ati o n t o n o m etr y  
•  
D evic e sit e e v al u ati o n  
•  
S ei d el’s t est  
•  
I m pl a nt sit e p h ot o gr a p h 
•  
A dv ers e ev e nts  
 
M o nt h 1 8  
•  
A p pl a n ati o n t o n o m etr y  
•  
D evic e sit e e v al u ati o n  
•  
S ei d el’s t est  
•  
I m pl a nt sit e p h ot o gr a p h 
•  
A dv ers e ev e nts  
M o nt h 2 1  
•  
A p pl a n ati o n t o n o m etr y  
•  
D evic e sit e e v al u ati o n  
•  
S ei d el’s t est  
•  
I m pl a nt sit e p h ot o gr a p h 
•  
A dv ers e ev e nts  
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 2  
M o nt h 2 4  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S) 
•  
A p pl a n ati o n t o n o m etr y  
•  
C e ntr al c or n e al t hic k n ess  
•  
Di ur n al I O P ass ess m e nt  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h al mic ex a mi n ati o n wit h dil at e d f u n d us ex a m 
•  
V ertic al C/ D r ati o ass ess m e nt  
•  
C or n e al s urf ac e st ai n  
•  
C or n e al e n d ot h eli al c ell c o u nt (s p ec ul ar micr o sc o py) 
•  
G o ni osc o py  
•  
O ptic n erv e i m a g e a n alysis  
•  
P eri m etr y  of n o n i m pl a nt e d e y e  
•  
S ei d el’s t est  
•  
Sc hir m er T e ar T est  
•  
L e ns st at us f or p h a kic ey es 
•  
Tr e at m e nt S atisf acti o n Q u esti o n n air e ( T S Q)  
•  
I m pl a nt sit e p h ot o gr a p h 
•  
B o dy t e m p er at ur e  
•  
A dv ers e ev e nts  
 
7. 2 .4  E A R L Y T E R MI N A TI O N VI SI T  
If a st u dy su bj ect’s p artici p ati o n i n t h e st u dy is t er mi n at e d e arly, a n E n d of St u dy c as e r e p ort  f or m m ust 
b e c o m pl et e d. D at a t o b e c oll ect e d i ncl u d e:  
•  
R e as o n f or wit h dr a w al / e arl y t er mi n ati o n  
•  
B est c orr ect e d vis u al ac uit y ( E T D R S)  
•  
A p pl a n ati o n t o n o m etr y  
•  
Slit l a m p ex a mi n ati o n  
•  
I n dir ect o p ht h al mic ex a mi n ati o n wit h dil at e d f u n d us ex a m  
•  
S e id el’s t est  
•  
Sc hir m er T e ar T est  
•  
L e ns st at us f or p h a kic ey es 
•  
I m pl a nt sit e p h ot o gr a p h 
•  
B o dy t e m p er at ur e  
•  
A dv ers e ev e nts  
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 3  
7. 2 .5  S C H E D U L E O F E V E N T S T A B L E  
 
T a bl e 3  Sc h e d ul e of E v e nts 
Pr oc e d ur es  
Scr e e ni n g/ B as eli n e  
I m pl a nt 
D a y 1  
W e e k 1  
W e e k 2  
M o nt h 1  
M o nt h 2   
M o nt h 3   
M o nt h 6 , 1 2 & 2 4 
M o nt h  4. 5, 8, 1 0, 1 5, 
1 8, & 2 1  
U nsc h e d ul e d  
I nf or m e d C o ns e nt 
X  
 
 
 
 
 
 
 
 
 
 
Eli gi bility V erific ati o n  
X  
 
 
 
 
 
 
 
 
 
 
M e dic al Hist ory (i ncl u di n g p hysic al 
ex a m)  
X  
 
 
 
 
 
 
 
 
 
 
B GI I m pl a nt  
 
X  
 
 
 
 
 
 
 
 
 
B est C orr ect e d Vis u al Ac uity ( E T D RS)  
X  
 
 
X  
X  
X  
X  
X  
X  
 
X  
A p pl a n ati o n T o n o m etry  
X  
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
Di ur n al I O P  
X  
 
 
 
 
 
 
 
X  
 
 
B o dy T e m p er at ur e  
X  
 
X  
X  
X  
X  
X  
X  
X  
 
X  
C e ntr al C or n e al T hick n ess  
X  
 
 
 
 
 
 
 
X  
 
 
Slit L a m p Ex a mi n ati o n  
X  
 
X  
X  
X  
X  
X  
X  
X  
 
X  
V ertic al C/ D R ati o   
X  
 
 
 
 
 
 
 
X  
 
 
C or n e al S urf ac e St ai n  
X  
 
 
 
 
 
 
 
X  
 
 
I n dir ect O p ht h al mic 
Ex a mi n ati o n/ Dil at e d F u n d us Ex a m  
X  
 
 
 
X  
X  
X  
X  
X  
 
X  
C or n e al E n d ot h eli al C ell C o u nt  
X  
 
 
 
 
 
 
X  
X  
 
 
G o ni osc o py  
X  
 
 
 
 
 
 
X  
X  
 
 
O ptic N erv e I m a g e A n alysis  
X  
 
 
 
 
 
 
 
X  
 
 
P eri m etry of n o n i m pl a nt e d ey e  
X  
 
 
 
 
 
 
 
X  
 
 
S ei d el’s T est  
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
Sc hir m er T e ar T est  
X  
 
 
 
 
X  
 
X  
X  
 
 
L e ns St at us f or P h akic Ey es  
X  
 
 
 
 
X  
 
X  
X  
 
 
Tr e at m e nt S atisf acti o n 
Q u esti o n n air e  
X  
 
 
 
 
X  
 
X  
X  
 
 
CI G TS  
X  
 
 
 
 
X  
 
X  
X  
 
 
I m pl a nt Sit e P h ot o gr a p h 
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
Scr e e ni n g C RF  
X  
 
 
 
 
 
 
 
 
 
 
I m pl a nt C RF 
 
X  
 
 
 
 
 
 
 
 
 
D ay 1 C RF  
 
 
X  
 
 
 
 
 
 
 
 
W e ek 1 C RF  
 
 
 
X  
 
 
 
 
 
 
 
W e ek 2/ M o nt h 2/ U nsc h e d ul e d C RF  
 
 
 
 
X  
 
X  
 
 
 
X  
M o nt h 1/ M o nt h 3 C RF  
 
 
 
 
 
X  
 
X  
 
 
 
M o nt h 6/ M o nt h 1 2/ M o nt h 2 4 C RF  
 
 
 
 
 
 
 
 
X  
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 4  
Pr oc e d ur es  
Scr e e ni n g/ B as eli n e  
I m pl a nt 
D a y 1  
W e e k 1  
W e e k 2  
M o nt h 1  
M o nt h 2   
M o nt h 3   
M o nt h 6 , 1 2 & 2 4 
M o nt h  4. 5, 8, 1 0, 1 5, 
1 8, & 2 1  
U nsc h e d ul e d  
M o nt h 4. 5, 8, 1 0, 1 5, 1 8, a n d 2 1 C R D  
 
 
 
 
 
 
 
 
 
X  
 
A dv ers e ev e nts  
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
M e dic ati o n L o g  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
D evic e Ex p eri e nc e C RF (if a p plic a bl e)  
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
Ex pl a nt ati o n C RF (if p erf or m e d)  
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
E n d of St u dy C RF ( w h e n c o n d uct e d)  
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 5  
7. 3  
C O N C O MI T A N T M E DI C A T I O N S, T R E A T M E N T S, A ND P R O C E D U R E S  
7. 3. 1  T R E A T M E N T O F I N F E C TI O N S 
Si nc e t h e Micr o O ptx Br o w n Gl a uc o m a I m pl a nt is a n ext er n ally c o m m u nic ati n g d e vic e, s p eci al c ar e m ust 
b e ex ercis e d t o w atc h f or a n d tr e at if n ec ess ar y a n y oc ul ar i nf ecti o ns. T h e p ati e nt a n d c ar e pr o vi d ers 
s h o ul d b e c o u ns el e d o n t h e si g ns of i nf ecti o n t o w atc h f or w hic h i ncl u d e: 
•  
R e d n ess  
•  
Oc ul ar disc o mf ort  
•  
H e a d ac h e  
•  
C h a n g e i n visi o n  
•  
Disc h ar g e at t h e i m pl a nt sit e  
•  
D evic e mi gr ati o n  
•  
C h a n g es i n t h e ext er n al a p p e ar a nc e of t h e ey e  
•  
Tiss u e h y p er pl asi a at t h e i m pl a nt sit e  
•  
Hy p o py o n  
•  
Hy p h e m a  
•  
U v eitis  
 
I nf ecti o ns of t h e e y e c a n r a pi dl y d a m a g e i m p ort a nt f u ncti o n al str uct ur es a n d l e a d t o p er m a n e nt visi o n 
l oss or bli n d n ess. A ny st u dy s u bj ect pr es e nti n g wit h  si g ns a n d sy m pt o ms of e n d o p ht h al mitis 
( hy p o py o n a n d a nt eri or c h a m b er c ell a n d fl ar e, wit h or wit h o ut vitr e o us c ell; p ai n, r e d n ess, etc) s h all 
b e ur g e ntly r ef e rr e d t o a vitr e o-r eti n al s ur g e o n, w h er e i nstit uti o n al b est pr actic es will b e f oll o w e d  t o 
o bt ai n gr a m -st ai ns, c ult ur es a n d s e ns ativiti es f or s us p ect e d i nf ecti o ns. Br o a d -s p ectr u m a nti bi otics 
s h o ul d b e a d mi nist er e d t o t h e a p pr o pri at e sit e of i nf ecti o n as s o o n as p ossi bl e . T o pic al dr o ps ar e 
pr ef err e d f or c or n e al a n d c o nj u ncti v al i nf ecti o ns. I ntr avitr e al a nti bi otics, a n d p ossi bl y s u bc o nj u nctiv al 
a n d p ar e nt er al a nti bi otics, ar e pr ef err e d f or e n d o p ht h al miti s. P ar e nt er al a nti bi otics ar e r ec o m m e n d e d 
f or i nf ecti o n i n d e e p a d n ex al str uct ur es. If i nf ecti o n occ urs, c ult ur e a n d s e nsitivity t esti n g s h o ul d b e 
u n d ert a k e n. M e dic al m a n a g e m e nt , i ncl u di n g o p ht h al mic a nti bi otics (s uc h as c o m bi n ati o n 
a mi n o glyc osi d es a n d c e p h al os p ori ns or fl u or o q ui n ol o n es ) or ex pl a nt  c a n b e c o nsi d er e d.   
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 6  
7. 3. 2  T R E A T M E N T O F H Y P O T O N Y  
Hy p ot o ny is a s eri o us c o n diti o n t h at c a n c a us e d a m a g e t o t h e i ntr a oc ul ar tiss u es a n d o ptic n er v e. It is a 
s eri o us ris k t o oc ul ar h e alt h a n d s h o ul d b e i m m e di at el y tr e at e d w h e n it is p ersist e nt or ass oci at e d wit h 
cli nic al si g ns. M a n a g e m e nt of hy p ot o ny i n B GI i m pl a nt p ati e nts s h o ul d es p eci ally b e c o nsi d er e d w h e n it 
is di a g n os e d at m or e t h a n 2 visits wit h I O P < 5 m m a n d w h e n  ass oci a t e d c o nc o mit a nt hy pt o n o us fi n di n gs 
ar e n ot e d , i ncl u di n g: 
•  
C or n e al e d e m a/f ol ds  
•  
 S h all o w a nt eri or c h a m b er  
•  
 H y p ot o n o us m ac ul o p at h y  
•  
S i g nific a nt c h or oi d al d et ac h m e nts or eff usi o n 
T h e Micr o O ptx Br o w n Gl a uc o m a is d esi g n e d t o ac hi e v e n or m ot e nsi o n i n t h e ey e . If h y p ot o ny d ev el o ps 
i n a p ati e nt wit h a B GI i m pl a nt, i n a d e q u at e h e ali n g a n d p eri p h er al fl o w of a q u e o us h u m or ar o u n d t h e 
tiss u e d evic e i nt erf ac e s h o ul d b e s us p ect e d. S ei d els t est will us u ally c o nfir m t h e pr es e nc e or a bs e nc e of 
a q u e o us h u m or p eri p h er al fl o w.   
If hy p ot o ny d e v el o ps aft er i m pl a nt ati o n of t h e B GI a n d t h e s u bj ect is c o nfir m e d t o h a v e c e ntr al fl o w of 
a q u e o us h u m or t hr o u g h t h e d e vic e, t h e n t h e p hysici a n m a y m e dic ally m a n a g e t h e hy p ot o ny as a d vis e d 
t hr o u g h st a n d ar d tr e at m e nt pr ot oc ols.   
Hy p ot o ny is b est m a n a g e d by c orr ecti n g t h e u n d erlyi n g pr o bl e m. As a t e m p orizi n g m e as ur e, t h e 
a nt eri or c h a m b er m a y b e i nfl at e d wit h visc o el astic or a p ars pl a n a i nj ecti o n of visc o el astic or g as m ay b e 
a d mi nist er e d. St er oi ds m ay b e us ef ul i n i n di vi d u als w h o ar e pr o n e t o a st er oi d r es p o ns e , a n d m ay 
i m pr ov e a q u e o us h u m or pr o d ucti o n b y d ecr e asi n g cili ar y b o dy i nfl a m m ati o n. I ncr e as e d fl ui d i nt ak e m ay 
sli g htl y i ncr e as e a q u e o us h u m or pr o d ucti o n. 
Wit h i nfl a m m at ory c o n diti o ns or wit h r ec e nt s ur g ery or tr a u m a, t o pic al pr e d nis ol o n e ac et at e or 
difl u pr e d n at e m ay b e c o nsi d er e d. A d diti o n al t h er a py, s uc h as t o pic al or syst e mic n o nst er oi d al a nti -
i nfl a m m at ory a g e nts ( N S AI Ds), syst e mic, s u b-T e n o n, or i ntr a vitr e a l st er oi ds, or ot h er s yst e mic 
m e dic ati o ns ( e g, m et h otr ex at e, c ycl os p ori n), m a y b e a p pr o pri at e. B ec a us e st er oi ds c a n sl o w w o u n d 
h e ali n g, us e s h o ul d b e m o d er at e d i n t h e c as e of p eri p h er al fl o w ar o u n d t h e tiss u e d e vic e i nt erf ac e.  
Atr o pi n e a n d ot h er c ycl o pl e gi cs d e e p e n t h e a nt eri or c h a m b er, l ess e n iris -c or n e al t o uc h, a n d r est or e 
n or m al a n at o my of t h e l e ns -iris di a p hr a g m a n d cili ary b o dy. U nf ort u n at ely, atr o pi n e als o i ncr e as es t h e 
uv e oscl er al o utfl o w a n d c a n c o ntri b ut e t o i ncr e as e d c h or oi d al eff usi o n . 
If si g nific a nt p ersist a nt hy p ot o ny p ersists, t h e d e vic e c a n b e e asily r e m o v e d a n d a s ut ur e c a n b e pl ac e d 
t hr o u g ht t h e i ncisi o ns sit e. T his m a n u ev er, as w ell as p h ar m ac ol o gic tr e at m e nts as n ot e d a b ov e, s h o ul d 
all o w a pr o m pt r es ol uti o n of t h e h y p ot o ny.   

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 7  
7. 3. 3  M A N A G E M E N T O F D E VI C E B L O C K A G E  
 
 
 
 
 
 
 
 
 
 
 
 
 
7. 3. 4  E X P L A N T A TI O N O F T H E B R O W N G L A U C O M A I M P L A N T  
T h e Micr o O ptx Br o w n Gl a uc o m a I m pl a nt s h o ul d b e ex pl a nt e d if a n y of t h e f oll o wi n g si g ns ar e n ot e d:  
•  
Extr e m e a n d p e rsist e nt oc ul ar disc o mf ort 
•  
Cli nic all y si g nific a nt i nf ecti o n  
•  
P arti al ext er n al mi gr ati o n of t h e B GI ass oci at e d wit h sit e i nfl a m m ati o n or n o d ul ar h y p er pl asi a  
•  
Si g nific a nt p eri p h er al fl o w of a q u e o us h u m or al o n g t h e o utsi d e d evic e -tiss u e i nt erf ac e is s e e n by 
S e i d el t esti n g 
•  
Si g nific a nt i nfl a m m ati o n ass oci at e d or p ossi bl y ass oci at e d wit h t h e d e vic e d ev el o ps  
•  
A ny sit u ati o n t h e att e n di n g o p ht h al m ol o gist f e els mi g ht b e n efit b e i m pr ov e d by d e vic e 
ex pl a nt ati o n  
E x pl a nt ati o n i n s etti n gs of c o m pl et e a n d n or m al h e ali n g :  
 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 8  
 
 
 
E x pl a nt ati o n i n t h e s etti n g of a l o os e d e vic e, o n e wit h p eri p h er al fl o w, i nf ecti o n, etc:  
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
7 .3 .5  P R E C A U TI O N A R Y M E DI C A TI O N S, T R E A T M E N T S, A N D P R O C E D U R E S  
Aft er i m pl a nt ati o n of t h e B GI, i ntr a -oc ul ar pr ess ur e s h o ul d b e cl os ely m o nit or e d. If pr ess ur es f all b el o w 
6  m m H g, eli mi n ati o n or r e d ucti o n of I O P -l o w eri n g m e dic ati o ns s h o ul d b e c o nsi d er e d. 
7. 3 .6  P R O HI BI T E D  M E DI C A TI O N S, T R E A T M E N T S, A N D  P R O C E D U R E S  
A ny p ost -i m pl a nt pr oc e d ur e or tr e at m e nt t h at p hysic ally i nt er acts wit h t h e B GI eit h er o n t h e s urf ac e of 
t h e ey e or i n t h e a nt eri or c h a m b er s h o ul d b e av oi d e d. T his excl u d es a ny tr e at m e nts or pr oc e d ur es 
d escri b e d i n t his pr ot oc ol f or tr e at m e nt of B GI or B GI i m pl a nt pr oc e d ur e r el at e d a dv ers e d evic e eff ects.   
7. 3 .7  P R O P H Y L A C TI C  M E DI C A TI O N S, T R E A T M E N T S, A N D P R O C E D U R E S  
St u dy s u bj ects  will r ec ei v e t o pic al a nti bi otic, c ortic ost er oi d, a n d n o n -st er oi d a nti-i nfl a m m at ory ( N S AI D) 
a g e nts t o b e gi n f o ur ti m es a d a y, o n e d ay pri or t o s ur gic al i m pl a nt ati o n of t h e B GI. T h es e s a m e 
m e dic ait o ns will b e us e d p ost -o p er ativ ely f or t w o w e e ks, a n d w hic h ti m e t h ey will b e r e d uc e d t o t wic e 
d aily u ntil t h e b ottl es ar e c o m pl et ely e m pty or u ntil o n e m o nt h fr o m s ur g ery, w hic h e v er c o m es fir st. 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
4 9  
B ottl e siz e s h o ul d b e 5 ml. T h e ex a mi ni n g s ur g e o n(s) c a n d et er mi n e if t h es e m e dic ait o ns s h o ul d b e 
pr ol o n g e d or r e d uc e d a ny s o o n er t h a n t his pr ot oc ol.   
St u dy s u bj ects  will als o r ec ei v e t hr e e s ets of dr o ps (t o i ncl u d e a nti bi otic, c oriticst er oi d, a n d N S A I D) t hr e e 
ti m es b et w e e n i n d ucti o n a n d c o m m e nc e m e nt of s ur g er y. T h e first s et of t h es e dr o ps c a n b e gi v e n i n t h e 
pr e -o p er ativ e ar e a of t h e s ur gic al s uit e, o nc e I V acc ess is o bt ai n e d.  
 
8  
A S S E S S M E N T O F S A F E T Y  
 
8 . 1 
S P E CI FI C A TI O N O F S A F E T Y P A R A M E T E R S  
All a dv ers e ev e nts o bs er v e d t hr o u g h o ut t h e st u dy will b e r e p o rt e d o n t h e A dv ers e E v e nt C R F.  
8 . 1. 1 D E FI NI TI O N O F A D V E R S E E V E N T S  ( A E) 
T h e f oll o wi n g d efi niti o n is  us e d:  
A dv ers e E v e nt ( A E): A ny u nt o w ar d m e dic al occ urr e nc e, u ni nt e n d e d dis e as e or i nj ur y or a n y 
u nt o w ar d cli nic al si g ns (i ncl u di n g a n a b n or m al l a b or at or y fi n di n g) i n s u bj ects, us ers or ot h er 
p ers o ns w h et h er or n ot r el at e d t o t h e i nv esti g ati o n al m e dic al d e vic e.  
N O T E 1:  T his d efi niti o n i ncl u d es e v e nts r el at e d t o t h e i nv esti g ati o n al d evic e or t h e c o m p a r at or. 
N O T E 2:  T his d efi niti o n i ncl u d es e v e nts r el at e d t o t h e pr oc e d ur es i n v ol v e d.  
N O T E 3:  F or us ers or ot h er p ers o ns, t his d efi niti o n is r estrict e d t o ev e nts r el at e d t o 
i nv esti g ati o nl m e dic al d e vic es.   
If a n a d v ers e e v e nt l e a ds t o m ulti pl e o utc o m es t h at s e q u e nti all y w ors e n, o nl y t h e w orst a d v ers e e v e nt is 
r e p ort e d. F or ex a m pl e, a b n or m al h e ali n g  l e a di n g t o i nf ecti o n w o ul d b e r e p ort e d as a si n gl e A E f or t h e 
i nf ecti o n. 
8 . 1. 2 D E FI NI TI O N O F S E RI O U S A D V E R S E E V E N T S  ( S A E) 
T h e f oll o wi n g d efi niti o n is us e d:  
S eri o us A dv ers e Ev e nt ( S A E): A dv ers e ev e nt t h at:  
a) l e d t o a d e at h,  
b) l e d t o a s eri o us d et eri or ati o n i n h e alt h of t h e s u bj ect, t h at eit h er r es ult e d i n: - a lif e -
t hr e at e ni n g ill n ess or i nj ur y, or —  a p er m a n e nt i m p air m e nt of a b o dy str uct ur e or a 
b o dy f u ncti o n , or —  i n-p ati e nt h os pit aliz ati o n or pr ol o n g ati o n of existi n g h os pit aliz ati o n, 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 0  
or —  i n m e dic al or s ur gic al i nt er v e nti o n t o pr e v e nt lif e t hr e at e ni n g ill n ess or —  i nj ur y or 
p er m a n e nt i m p air m e nt t o a b o dy str uct ur e or a b o dy f u ncti o n.  
c) l e d t o f o et al distr ess, f o et al d e at h or a c o n g e nit al a b n or m alit y or birt h d ef ect.  
N ot e: Pl a n n e d h os pit aliz ati o n f or a pr e -existi n g c o n diti o n or a pr oc e d ur e r e q uir e d b y t h e pr ot oc ol ( e. g., 
t h e i n d ex i m pl a nt pr oc e d ur e), wit h o ut s eri o us d et eri or ati o n i n h e alt h, is n ot c o nsi d er ed a s eri o us 
a dv ers e ev e nt.  
8. 1. 3  A D V E R S E D E VI C E E F F E C T ( A D E ) 
T h e f oll o wi n g d efi niti o n is us e d:  
 
A dv ers e D e vic e Eff ect ( A D E): A n a dv ers e ev e nt t h at is r el at e d t o t h e us e of a n i nv esti g ati o n al 
m e dic al d e vic e . 
T his d efi niti o n i ncl u d es a dv ers e e v e nts r es ulti n g fr o m i ns uffici e nt or i n a d e q u at e i nstr ucti o ns f or us e, 
d e pl o y m e nt, i m pl a nt ati o n, i nst all ati o n, or o p er ati o n, or a n y m alf u ncti o n of t h e i n v esti g ati o n al m e dic al 
d e vic e.  T his d efi niti o n  als o i ncl u d es a ny e v e nt r es ulti n g fr o m us e err or or fr o m i nt e ntio n al mis us e of t h e 
i nv esti g ati o n al m e dic al d evic e. 
8. 1. 4  S E RI O U S A D V E R S E D E V I C E E F F E C T (S A D E ) 
A dv ers e d e vic e eff ect t h at h as r es ult e d i n a ny of t h e c o ns e q u e nc es c h ar act eristic of a s eri o us a dv ers e 
e v e nt.  
8 . 1.5  U N A N TI CI P A T E D  S E RI O U S  A D V E R S E D E VI C E E F F E C T ( U S A D E ) 
T h e f oll o wi n g d efi niti o n is us e d:  
U n a ntici p at e d S eri o us A dv ers e D evic e Eff ect ( U S A D E): A s eri o us a d v ers e d evic e eff ect w hic h b y 
its n at ur e, i nci d e nc e, s ev erit y or o utc o m e h as n ot b e e n i d e ntifi e d i n t h e c urr e nt v ersi o n of t h e 
ris k a n al ysis r e p ort.   
N O T E: A ntici p at e d S A D E ( A S A D E): a n eff ect w hic h b y its n at ur e, i nci d e nc e, s ev erit y  
or o utc o m e h as b e e n pr evi o usl y i d e ntifi e d i n t h e ris k a n al ysis r e p ort . 
 
8. 1. 6  P R E -S P E CI FI E D LI S T O F A D V E R S E E V E N T S  
A dv ers e ev e nts list e d b el o w ar e p r ovi d e d o n t h e c as e r e p ort f or m al o n g wit h a m et h o d f or r ec or di n g 
ot h er a dv ers e e v e nts n ot list e d, b as e d o n t h e r ec o g niz e d st a n d ar d A N SI Z 8 0. 2 7 -2 0 1 4. 7  
 
•  
C or n e al e d e m a  
•  
Pr o gr essi o n of c at ar act r e q uiri n g c at ar act extr acti o n  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 1  
•  
W o u n d l e ak  
•  
S ut ur e a bsc ess or ot h er l oc al i nf ecti o n  
•  
E n d o p ht h al mitis  
•  
C hr o nic iritis  
•  
Hy p h e m a  
•  
Str a bis m us  
•  
M ac ul ar e d e m a  
•  
Vitr e o us h e m orr h a g e  
•  
S u pr ac h or oi d al h e m orr h a g e  
•  
R eti n al d et ac h m e nt  
•  
D evic e m alf u ncti o n  
•  
D evic e bl oc k a g e n ot r e q uiri n g s ur gic al r e visi o n  
•  
D evic e bl oc k a g e r e q uiri n g s ur gic al r e visi o n 
•  
I m pl a nt mi gr ati o n ( of a n y ki n d) n ot r e q uiri n g s ur gic al i nt er v e nti o n 
•  
I m pl a nt mi gr ati o n r e q uiri n g s ur gic al r evisi o n 
•  
I m pl a nt ex p os ur e or extr usi o n 
•  
Fl at a nt eri or c h a m b er r e q uiri n g a nt eri or c h a m b er r ef or m ati o n  
•  
Hy p ot o ny ( e. g., I O P < 6 m m H G a n d ass oci at e d wit h c o nc o mit a nt hy p ot o n o us fi n di n gs ar e n ot e d, 
i ncl u di n g:  C or n e al e d e m a/f ol ds, s h all o w a nt eri or c h a m b er, hy p ot o n o us m ac ul o p at h y, 
si g nific a nt c h or oi d al d et ac h m e nts or eff usi o n) 
•  
Hy p ot o ny m ac ul o p at hy  
•  
C h or oi d al eff usi o n r e q uiri n g s ur gic al dr ai n a g e  
•  
S u bst a nti al i ncr e as e i n I O P vs. b as eli n e  ( d efi n e d as > 1 0 m m H g)  
•  
S u bst a nti al vis u al fi el d l oss vs. b as eli n e ( e. g., 1 0 d b l oss)  
•  
S u bst a nti al vis u al ac uit y l oss vs. b as eli n e ( e. g. 1 0 or m or e E T D R S l ett ers)  
•  
E v e nt r e q uiri n g u n pl a n n e d oc ul ar s ur gic al r e-i nt erv e nti o n 
 
8 . 2 
C L A S SI FI C A TI O N O F A N  A D V E R S E E V E N T  
 
8 . 2.1  R E L A TI O N S HI P T O D E VI C E O R P R O C E D U R E  —  C A U S A LI T Y  
T h e r el ati o ns hi p b et w e e n t h e us e of t h e m e dic al d e vic e (i ncl u di n g t h e m e dic al —  s ur gic al pr oc e d ur e) 
a n d t h e occ urr e nc e of e ac h a dv ers e ev e nt s h al l b e ass ess e d a n d c at e g oriz e d. D uri n g c a us alit y 
ass ess m e nt activity, cli nic al j u d g e m e nt s h all b e us e d a n d t h e r el e v a nt d oc u m e nts, s uc h as t h e 
I nv esti g at or’s Br oc h ur e, t h e Cli nic al Pr ot oc ol or t h e risk A n al ysis R e p ort s h all b e c o ns ult e d, as all t h e 
f or es e e a bl e s eri o us a dv ers e ev e nts a n d t h e p ot e nti al ris ks ar e list e d a n d ass ess e d t h er e. T h e pr es e nc e of 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 2  
co nf o u n di n g f act ors, s uc h as c o nc o mit a nt m e dic ati o n/tr e at m e nt, t h e n at ur al hist or y of t h e u n d erl yi n g 
dis e as e, ot h er c o nc urr e nt ill n ess or ris k f act ors  s h all als o b e c o nsi d er e d.  
 
E ac h A E will b e cl assifi e d acc or di n g t o fi v e diff er e nt l e v els of c a us ality. T h e S p o ns or  a n d t h e I nv esti g at ors 
will us e t h e f oll o wi n g d efi niti o ns t o ass ess t h e r el ati o ns hi p of t h e s eri o us a dv ers e e v e nt t o t h e 
i nv esti g ati o n al m e dic al d evic e or pr oc e d ur es. 
1) N ot r el at e d:  r el ati o ns hi p t o t h e d e vic e or pr oc e d ur es c a n b e excl u d e d w h e n:  
- t h e ev e nt is n ot a k n o w n si d e eff ect of t h e pr o d uct c at e g ory t h e d evic e b el o n gs t o or of 
si mil ar d evic es a n d pr oc e d ur es;  
- t h e ev e nt h as n o t e m p oral r el ati o ns hi p wit h t h e us e of t h e i n v esti g ati o n al d evic e or t h e 
pr oc e d ur es;  
- t h e ev e nt d o es n ot f oll o w a k n o w n r es p o ns e p att er n t o t h e m e dic al d e vic e (if t h e 
r es p o ns e p att er n is pr evi o usl y k n o w n) a n d is bi ol o gic all y i m pl a usi bl e;   
- t h e disc o nti n u ati o n of m e dic al d e vic e a p plic ati o n or t h e r e d ucti o n of t h e l ev el of 
acti v ati o n/ ex p os ur e —  w h e n cli nic all y f e asi bl e —  a n d r ei ntr o d ucti o n of its us e ( or 
i ncr e as e of t h e l ev el of activ ati o n/ ex p os ur e), d o n ot i m p act o n t h e s eri o us e v e nt;  
- t h e ev e nt i n v ol v es a b ody -sit e or a n or g a n n ot ex p ect e d t o b e aff ect e d b y t h e d e vic e or 
pr oc e d ur e;  
- t h e ev e nt c a n b e attri b ut e d t o a n ot h er c a us e ( e. g. a n u n d erl yi n g or c o nc urr e nt ill n ess/ 
cli nic al c o n diti o n, a n eff ect of a n ot h er d e vic e, dr u g, tr e at m e nt or ot h er ris k f act ors);  
- t h e ev e nt d o es n ot d e p e n d o n a f als e r es ult giv e n b y t h e i n v esti g ati o n al devic e us e d f or 
di a g n osis, w h e n a p plic a bl e;  
- h ar ms t o t h e s u bj ect  ar e n ot cl e arl y d u e t o us e err or;  
- I n or d er t o est a blis h t h e n o n-r el at e d n ess, n ot all t h e crit eri a list e d a b o v e mi g ht b e m et 
at t h e s a m e ti m e, d e p e n di n g o n t h e t y p e of d evic e/ pr oc e d ur es a n d t h e s eri o us ev e nt.  
2) U nli k el y:  t h e r el ati o ns hi p wit h t h e us e of t h e d evic e s e e ms n ot r el e v a nt a n d/ or t h e ev e nt c a n 
b e r e as o n a bl y ex pl ai n e d by a n ot h er c a us e, b ut a d diti o n al i nf or m ati o n m ay b e o bt ai n e d.  
3 ) P ossi bl e: t h e r el ati o ns hi p wit h t h e us e of t h e i nv esti g ati o n al d evic e is w e a k b ut c a n n ot b e 
r ul e d o ut c o m pl et el y. Alt er n ati v e c a us es ar e als o p ossi bl e ( e. g. a n u n d erl yi n g or c o nc urr e nt 
ill n ess/ cli nic al c o n diti o n or/ a n d a n eff ect of a n ot h er d e vic e, dr u g or tr e at m e nt). C as es wh er e 
r el at e d n ess c a n n ot b e ass ess e d or n o i nf or m ati o n h as b e e n o bt ai n e d s h o ul d als o b e cl assifi e d as 
p ossi bl e.  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 3  
4) Pr o b a bl e : t h e r el ati o ns hi p wit h t h e us e of t h e i n v esti g ati o n al d evic e s e e ms r el e v a nt a n d/ or 
t h e ev e nt c a n n ot r e as o n a bly ex pl ai n e d b y a n ot h er c a us e, b ut a d diti o n al i nf orm ati o n m a y b e 
o bt ai n e d.  
5) C a us al r el ati o ns hi p : t h e e v e nt is ass oci at e d wit h t h e i nv esti g ati o n al d evic e or wit h 
pr oc e d ur es b e y o n d r e as o n a bl e d o u bt w h e n:  
- t h e ev e nt is a k n o w n si d e eff ect of t h e pr o d uct c at e g or y t h e d evic e b el o n gs t o or of 
si mil ar d evic es a n d pr oc e d ur es;  
- t h e ev e nt h as a t e m p or al r el ati o ns hi p wit h i nv esti g ati o n al d evic e us e/ a p plic ati o n or 
pr oc e d ur es;   
- t h e ev e nt i n v ol v es a b o dy-sit e or or g a n t h at: 
•  
t h e i n v esti g ati o n al d evic e or pr oc e d ur es ar e a p pli e d t o;   
•  
t h e i n v esti g ati o n al d evic e or pr oc e d ur es h av e a n eff ect o n;  
 - t h e s eri o us ev e nt f oll o ws a k n o w n r es p o ns e p att er n t o t h e m e dic al d e vic e (if t h e 
r es p o ns e p att er n is pr evi o usl y k n o w n);  
- t h e disc o nti n u ati o n of m e dic al d e vic e a p plic ati o n ( or r e d ucti o n of t h e l ev el of 
acti v ati o n/ ex p os ur e) a n d r ei ntr o d ucti o n of its us e ( or i ncr e as e of  t h e l ev el of 
acti v ati o n/ ex p os ur e), i m p act o n t h e e v e nt ( w h e n cli nic ally f e asi bl e);    
- ot h er p ossi bl e c a us es ( e. g. a n u n d erl yi n g or c o nc urr e nt ill n ess/ cli nic al c o n diti o n 
or/ a n d  a n eff ect of a n ot h er d e vic e, dr u g or tr e at m e nt) h a v e b e e n a d e q u at ely r ul e d o ut;  
- h ar m t o t h e s u bj ect  is d u e t o err or i n us e;  
- t h e ev e nt d e p e n ds o n a f als e r es ult giv e n b y t h e i n v esti g ati o n al d e vic e us e d f or 
di a g n osis, w h e n a p plic a bl e;   
- I n or d er t o est a blis h t h e r el at e d n ess, n ot all t h e crit eri a list e d a b o v e mi g ht b e m et at 
t h e s a m e ti m e, d e p e n di n g o n t h e t y p e of d evic e/ pr oc e d ur es a n d t h e ev e nt. 
T h e S p o ns or  a n d Iinv esti g at or  will disti n g uis h b et w e e n t h e s eri o us a dv ers e ev e nts r el at e d t o t h e 
i nv esti g ati o n al d evic e a n d t h os e r el at e d t o t h e pr oc e d ur es ( a n y pr oc e d ur e s p ecific t o t h e cli nic al 
i nv esti g ati o n). A n a dv ers e e v e nt c a n b e r el at e d b ot h t o pr oc e d ur es a n d th e i nv esti g ati o n al d evic e. 
C o m plic ati o ns of pr oc e d ur es ar e  c o nsi d er e d n ot r el at e d if t h e s ai d pr oc e d ur es w o ul d h a v e b e e n a p pli e d 
t o t h e p ati e nts als o i n t h e a bs e nc e of i nv esti g ati o n al d e vic e us e/ a p plic ati o n.  
R el at e d t o D e vic e -  Ev e nts r e as o n a bl y a ntici p a t e d t o b e r el at e d t o t h e p hysic al pr es e nc e of t h e 
d e vic e, e. g. er osi o n, a d e vic e d efici e nc y, disl o d g m e nt .  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 4  
R el at e d t o Pr oc e d ur e  —  Ev e nts r e as o n a bl y a ntici p at e d t o b e r el at e d t o pr oc e d ur es ( p ert ai ni n g 
t o i m pl a nt) d escri b e d i n t his pr ot oc ol.  
N O T E: Pr oc e d ur e r el at e d ev e nts r ef ers t o t h e pr oc e d ur e r el at e d t o t h e i niti al a p plic ati o n of t h e 
i nv esti g ati o n al m e dic al d evic e o nl y a n d t h er ef or e n ot t o a n y ot h er pr oc e d ur es or tr e at m e nts 
a p pli e d l at er t hr o u g h o ut t h e cli nic al i nv esti g ati o n, f or i nst a nc e t o tr e a t (s eri o us) a dv ers e ev e nts. 
 
I n s o m e p artic ul ar c as es t h e ev e nt m ay b e n ot a d e q u at el y ass ess e d b ec a us e i nf or m ati o n is i ns uffici e nt 
or c o ntr a dict ory a n d/ or t h e d at a c a n n ot b e v erifi e d or s u p pl e m e nt e d.  T h e S sp o ns or  a n d t h e 
I nv esti g at ors will m a k e t h e m axi m um eff ort t o d efi n e a n d c at e g oriz e t h e ev e nt a n d a v oi d t h es e 
sit u ati o ns. W h er e t h e S p o ns or  r e m ai ns u nc ert ai n a b o ut cl assifyi n g t h e s eri o us ev e nt, it s h o ul d n ot 
excl u d e t h e r el at e d n ess a n d cl assif y t h e e v e nt as “ p ossi bl e”.   
P artic ul ar att e nti o n s h all b e gi v e n t o t h e c a us ality ev al u ati o n of u n a ntici p at e d s eri o us a d v ers e ( d evic e) 
e v e nts. T h e occ urr e nc e of u n a ntici p at e d ev e nts r el at e d t o t h e us e of t h e d evic e ( U S A D E) c o ul d s u g g est 
t h at t h e cli nic al i n v esti g ati o n pl ac es s u bj ects at i ncr e as e d ris k of h ar m t h a n w as t o b e ex p ect e d 
b ef or e h a n d.  
All A Es will b e c oll ect e d fr o m t h e ti m e of i nf or m e d c o ns e nt t hr o u g h t h e e n d of t h e st u dy. D e at h s h o ul d 
n ot b e r ec or d e d as a s e p ar at e a dv ers e ev e nt, b ut r at h er as a n o utc o m e of t h e s p ecific S A E w hic h l e d t o 
t h e su bj ect’s d e at h. A dv ers e E v e nts t h at w o ul d b e r e as o n a bl y ex p ect e d t o b e ass oci at e d wit h a n y 
s ur gic al pr oc e d ur e ( e. g.: a n est h esi a ass oci at e d n a us e a, s ur gic al sit e p ai n) will n ot b e c at e g oriz e d as 
pr oc e d ur e or d e vic e r el at e d i n t h e 3 0 d ays p ost t h e s ur gic al pr oc e d ur e.  
N ot es :  
1.  A ny c urr e nt c o n diti o n t h at is r ec or d e d as a pr e -existi n g c o n diti o n is n ot a n A E, u nl ess t h er e 
is a w ors e ni n g of t h at c o n diti o n i n t er ms of n at ur e, s ev erity, or d e gr e e of i nci d e nc e.  
2.  T ec h nic al o bs erv ati o ns –  a n u n d esir a bl e d evic e e v e nt t h at d o es n ot r es u lt i n a m e dic ally 
u n d esir a bl e sit u ati o n f or t h e su bj ect –  is n ot a n A E.  
3.  Pl a n n e d h os pit aliz ati o n f or a pr oc e d ur e r e q uir e d by t his pr ot oc ol is n ot a n A E. H o w e v er, 
c o m plic ati o ns d uri n g t h e c o urs e of t h at pl a n n e d h os pit aliz ati o n t h at pr ol o n g t h e a ntici p at e d 
d ur ati o n of t h e h os pit aliz ati o n d o c o nstit ut e S A Es.  
4.  El ectiv e h os pit aliz ati o n f or a pr e -existi n g ill n ess d o es n ot c o nstit ut e a n S A E u nl ess t h e ill n ess 
h as w ors e n e d i n t h e n at ur e, s ev erity or d e gr e e of t h e c o n diti o n wit h r es p ect t o b as eli n e.  
5.  D evic e disl o d g m e nt/ ex p ulsi o n  will n ot b e c oll ect e d as a n A E, b ut r at h er as a d evic e 
d efici e nc y. If d evic e mi gr ati o n r es ults i n a cli nic al s y m pt o m, r e p ort t his as a n A E i n a d diti o n 
t o t h e d evic e d efici e nc y r e p ort d oc u m e nti n g d evic e disl o d g m e nt/ ex p ulsi o n .  
6.  L ac k of effic acy or di mi nis h e d t h er a p e utic r es p o ns e d o es n ot c o nstit ut e a n A E si nc e f ail ur e 
t o r ec eiv e t h er a p e utic b e n efit is a n iss u e of effic acy, n ot s af ety. T his i ncl u d es s y m pt o ms t h at 
r ec ur i n t h e c o nt ext of d evic e d efici e nc y l ea di n g t o l oss of t h er a py .  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 5  
7.  R e m ov al a n d/ or r e pl ac e m e nt of t h e d evic e d u e t o m alf u ncti o n w o ul d b e c o nsi d er e d a 
d e vic e r el at e d a d v ers e ev e nt  
8 . 3 
TI M E P E RI O D A N D F R E Q U E N C Y F O R E V E N T A S S E S S M E N T A N D F O L L O W -U P  
A dv ers e ev e nts will b e  m o nit or e d t hr o u g h st u dy cl os ur e.   E ac h sc h e d ul e d a n d u nsc h e d ul e d f oll o w -u p 
visit will i ncl u d e acti v e asc ert ai n m e nt of n e w a d v ers e e v e nts, as w ell as f oll o w -u p of pr evi o usl y r e p ort e d, 
o n g oi n g a d v ers e ev e nts.   All st u dy s u bj ects will b e e d uc at e d o n t h e a ntici p at e d a dv ers e ev e nts 
ass oci a t e d wit h t h e B GI a n d oc ul ar s ur g ery t hr o u g h t h e c o ns e nti n g pr oc ess. T h ey will b e i nstr uct e d t o 
c o nt act t h eir p hysici a n if t h e y ex p eri e nc e a ny a d v ers e e v e nts d uri n g t h eir p artici p ati o n i n t h e tri al . All 
a dv ers e ev e nts will b e d oc u m e nt e d o n t h e a dv ers e ev e nt  f or ms.   
8 . 4 
R E P O R TI N G P R O C E D U R E S  
 
8 . 4. 1 A D V E R S E E V E N T R E P O R T I N G  
T h e I nv esti g at or will m o nit or t h e occ urr e nc e of a d v ers e ev e nts f or e ac h e nr oll e d S u bj ect. A dv ers e 
e v e nts r e p ort e d b y t h e S u bj ect t o t h e I nv esti g at or, c o nfir m e d b y t h e I nv esti g at or, a n d d oc um e nt e d i n 
m e dic al r ec or ds m ust b e r e p ort e d o n t h e a dv ers e ev e nt f or m b as e d o n t h e r e q uir e m e nts of t h e st u dy 
CI P. All A D Es, S A Es, S A D Es, a n d U S A D Es will b e r e p ort e d t o all I nv esti g at ors a n d I R Bs a n d/ or Et hics 
C o m mitt e es p artici p ati n g i n t h e st u dy p er t h eir r e p orti n g r e q uir e m e nts. T his is d o n e by m e a ns of a n 
i nt eri m r e p ort or a fi n al st u dy r e p ort pr e p ar e d b y t h e S p o ns or . 
8 . 4. 2 S E RI O U S A D V E R S E E V E N T R E P O R TI N G  
S eri o us a dv ers e ev e nts ar e t o b e r e p ort e d t o t h e S p o ns or  by t h e I nv esti g at or wit hi n t hr e e w orki n g d a ys 
of b ec o mi n g a w ar e of t h e e v e nt  i n c o m pli a nc e wit h M E D D E V 2. 7/ 3 r evisi o n 3 M a y 2 0 1 5; G ui d eli n es o n 
M e dic al D evic es Cli nic al I nv esti g ati o ns: S eri o us A dv ers e E v e nt R e p orti n g U n d er Dir ectiv es 9 0/ 3 8 5/ E ec 
A n d 9 3/ 4 2/ E E C.  
 
8. 5  
D E VI C E D E F I CI E N CI E S 
D evic e d efici e nci es ar e d efi n e d as i n a d e q u ac y of a n i nv esti g ati o n al m e dic al d evic e r el at e d t o its i d e ntity, 
q u alit y,  d ur a bilit y, r eli a bility, s af et y or p erf or m a nc e. T his m ay i ncl u d e m alf u ncti o ns, us e err or,  
or i n a d e q u acy i n t h e i nf or m ati o n s u p pl i e d b y t h e m a n uf act ur er.  
 
All s us p ect e d i n v esti g ati o n al d e vic e d efici e nci es s h o ul d b e d oc u m e nt e d o n t h e a p pr o pri at e C R F. T h e 
S p o ns or  will i nv esti g at e all s us p ect e d d e vic e d efici e nci es.  
N ot e: a d evic e d efici e nc y c a n i ncl u d e a d evic e m alf u ncti o n (i. e.: f ai l ur e t o p erf or m t o s p ecific ati o ns), a n d 
m a y als o i ncl u d e ot h er d efici e nci es ( e. g.: a m bi g uit y of l a b elli n g).  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 6  
F or t h e B GI , n ot all d e vic e d efici e nci es will l e a d t o a n ex pl a nt. F or ex a m pl e, if p at e nc y is l ost b ut t h e 
d e vic e is n ot c a usi n g disc o mf ort, t h e I nvesti g at or  a n d st u dy s u bj ect m ay el ect t o l e a v e t h e d e vic e i n 
pl ac e w hil e i m pl a nti n g a s ec o n d d evic e or s e eki n g alt er n ati v e tr e at m e nt . T h us a d e vic e d efici e nc y m ay 
n ot n ec ess arily l e a d t o a n A E or S A E. If ex pl a nt e d , a d evic e wit h a s us p ect e d m alf u ncti o n s h oul d b e 
r et ur n e d t o Micr o O ptx  f or a n al ysis. If it is n ot p ossi bl e t o r et ur n t h e d evic e, t h e r e as o n it c o ul d n ot b e 
r et ur n e d as w ell as its fi n al dis p ositi o n s h o ul d b e d oc u m e nt e d. N ot e t h at r e p orti n g of d evic e d efici e nci es 
s h all b e s e p ar at e fr o m a dv ers e e v e nt r e p orti n g. If t h er e s h o ul d b e a n a dv ers e ev e nt ass oci at e d wit h t h e 
d e vic e d efici e nc y, t h e n t h at a dv ers e e v e nt s h o ul d b e r e p ort e d o n a n a d v ers e e v e nt C R F.  
8. 6  
S U BJ E C T D E A T H   
A su bj ect d e at h d uri n g t h e st u dy s h o ul d b e r e p ort e d t o t h e S p o ns or  as s o o n as p ossi bl e a n d, i n a ny 
e v e nt, wit hi n t w o w orki n g d a ys of n otific ati o n t o t h e I nv esti g at or. T h e c e nt er’s I R B or Et hics C o m mitt e e 
m ust b e n otifi e d of a n y d e at hs i n acc or d a nc e wit h t h at c e nt er’s I R B or Et hics C o m mitt e e p olici es a n d 
pr oc e d ur es. N otific ati o n of d e at h s h o ul d i ncl u d e a d et ail e d n arr ati v e ( d e at h l ett er) t h at pr o vi d es 
d et ail e d i nf or m ati o n d escri bi n g t h e circ u mst a nc es s urr o u n di n g t h e d e at h a n d is si g n e d b y t h e pri nci p al 
I nv esti gat or  or a ut h oriz e d S u b -I nv esti g at or. T h e d e at h l ett er s h o ul d i ncl u d e all of t h e f oll o wi n g:   
•  
D at e a n d ti m e of d e at h  
•  
Pl ac e d e at h occ urr e d  
•  
I m m e di at e c a us e of d e at h  
•  
W h et h er or n ot t h e d e at h w as wit n ess e d  
•  
D evic e st at us at t h e ti m e of d e at h, if k n o w n   
•  
A ny ot h er circ u mst a nc es s urr o u n di n g t h e d e at h  
•  
A p pr oxi m at e ti m e i nt er v al fr o m t h e i niti ati n g ev e nt t o d e at h (t e m p or al c o urs e)  
•  
I nv esti g at or or s u b -I nv esti g at or si g n at ur e a n d d at e  
A ny i nf or m ati o n list e d a b ov e t h at is u n av ail a bl e or u nk n o w n m ust b e s p ecifi e d as  s uc h i n t h e d e at h 
l ett er.  If t h e su bj ect ex pir e d i n t h e h os pit al, t h e f oll o wi n g d oc u m e nt ati o n s h o ul d als o b e s u b mitt e d:  
•  
A c o py of t h e m e dic al r ec or ds f or t h at a d missi o n ( e. g., c o ns ults, t est r es ults, o p er ati v e r e p orts, 
a n d/ or pr o gr ess n ot es fr o m t h e h os pit al c h art)  
•  
D e at h c ertific at e (if av ail a bl e)  
•  
A ut o ps y r e p ort (if a p plic a bl e)  
If t h e su bj ect ex pir e d o utsi d e of t h e h os pit al ( e. g., h o m e):  
•  
A c o py of t h e m ost r ec e nt cli nic visit (if n ot alr e a dy s u b mitt e d t o t h e S p o ns or )  
•  
D e at h c ertific at e (if av ail a bl e)  
As a p plic a bl e p er l oc al c o u ntr y r e g ul ati o n, t h e ev e nt s h o ul d b e r e p ort e d b y t h e I nv esti g at or t o t h e 
a p pr o pri at e r e g ul at ory b o di es.  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 7  
8 .7  
S T U D Y  H A L TI N G R U L E S  
T h er e ar e n o st atistic ally -b as e d r ul es r el at e d t o e arly tri al t er mi n ati o n. H o w ev er, if t w o of t h e first fiv e 
s u bj ects ex p eri e nc e a s eri o us d e vic e or pr oc e d ur e r el at e d a d v ers e ev e nt, or if t hr e e t ot al s u bj ects 
ex p eri e nc e a s eri o us d evic e or pr oc e d ur e r el at e d a dv ers e e v e nt, t h e st u dy will b e h alt e d u ntil t h e ti m e 
a n acc e pt a bl e (t o F D A a n d s p o ns or) miti g ati o n c a n b e i m pl e m e nt e d.  If n o s uc h miti g ati o n is p ossi bl e, 
t h e st u dy will b e t er mi n at e d.  I n a d diti o n, t h e S p o ns or  a n d i n d e p e n d e nt M e dic al D ir ect or will r e vi e w 
s af et y d at a e v er y t w o m o nt hs , i ncl u di n g t h e e m er g e nc e of s eri o us a dv ers e ev e nts a n d u n a ntici p at e d 
a dv ers e d evic e eff ects, a n d will c o nv e n e a s p eci al s essi o n of t h e D S M B if t h e o bs er v e d risks a p p e ar 
gr e at er t h a n ex p ect e d , ev e n if t h e st o p pi n g r ul e is n ot m et.   
8 .8  
S A F E T Y O V E R SI G H T  
A D at a S af ety M o nit ori n g B o ar d ( D S M B) will b e ass e m bl e d t o r o uti n el y m o nit or o n g oi n g s af ety of tri al 
p artici p a nts.  T h e D S M B will m e et at l e ast q u art erl y a n d, u p o n d at a r e vi e w, m ak e r ec o m m e n d ati o ns t o 
t h e s po ns or t o:  
•  
C o nti n u e t h e tri al as pl a n n e d  
•  
C o nti n u e t h e tri al wit h m o dific ati o n(s), or  
•  
T er mi n at e t h e tri al d u e t o s af et y c o nc er ns . 
A D S M B c h art er will b e d ev el o p e d s e p ar at el y i n a c o o p er ati v e eff ort b et w e e n s p o ns or a n d t h e D S M B.    
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 8  
9  
C LI NIC A L  M O N IT O R IN G  
It is t h e r es p o nsi bilit y of t h e S p o ns or  t o e ns ur e pr o p er m o nit ori n g of t h e st u dy p er r e g ul ati o ns. 
A p pr o pri at el y tr ai n e d S p o ns or  p ers o n n el or d el e g at es a p p oi nt e d b y t h e S p o ns or  will p erf or m st u dy 
m o nit ori n g at t h e i n v esti g ati o n sit e i n or d er t o e ns ur e t h at t h e st u dy is c o n d uct e d i n acc or d a nc e wit h 
t h e CI P, t h e si g n e d Cli nic al Tri al A gr e e m e nt, a n d a p plic a bl e r e g ul at or y r e q uir e m e nts. T h e S p o ns or  m ust 
t h er ef or e b e all o w e d acc ess t o t h e S u bj ects’ cli nic a n d h os pit al r ec or ds w h e n s o r e q u est e d as p er t h e 
c o ns e nt for m, P riv acy A ut h oriz ati o n ( U S o nl y) a n d Cli nic al Tri al A gr e e m e nt.  
Pr oc e d ur es r e q uir e d i n t his CI P r e q uir e s o urc e d oc u m e nt v erific ati o n f or t his st u dy. A s e p ar at e 
M o nit ori n g Pl a n will d et ail l e v els of s o urc e v erific ati o n f or t his st u dy. M o nit ori n g visits will b e c o n d uct e d 
p eri o dic all y t o ass ess st u dy pr o gr ess, t h e I nv esti g at or’s a d h er e nc e t o t h e CI P a n d r e g ul at ory c o m pli a nc e. 
T his i ncl u d es b ut is n ot li mit e d t o I R B/ E C a p pr ov al a n d r e vi e w of t h e st u dy, m ai nt e n a nc e of r ec or ds a n d 
r e p orts, r evi e w of t h e c o ns ent pr oc ess a n d r evi e w of s o urc e d oc u m e nts a g ai nst S u bj ect c as e r e p ort 
f or ms t o e ns ur e d at a p oi nts ar e c orr ect a n d t h at a dv ers e ev e nts ar e b ei n g r e p ort e d.  
M o nit ors f acilit at e sit e r e g ul at or y a n d st u dy c o m pli a nc e by i d e ntif yi n g fi n di n gs of n o n -c o m pli a nc e a nd 
c o m m u nic ati n g t h os e fi n di n gs al o n g wit h r ec o m m e n d ati o ns f or pr e v e nt ativ e/c orr ectiv e acti o ns t o sit e 
p ers o n n el. C o m m u nic ati o n wit h t h e sit e p ers o n n el occ urs d uri n g t h e visit a n d f oll o wi n g t h e visit vi a a 
writt e n f oll o w -u p l ett er. M o nit ors m a y w or k wit h st u dy p ers o n n el t o d et er mi n e a p pr o pri at e c orr ectiv e 
acti o n r ec o m m e n d ati o ns a n d t o i d e ntify tr e n ds wit hi n t h e st u dy or at a p artic ul ar c e nt er.  
Fr e q u e nc y of m o nit ori n g visits will occ ur b as e d o n su bj ect e nr oll m e nt, ti mi n g of t h e st u dy visits, 
d ur ati o n of t h e st u dy, st u dy c o m pli a nc e, fi n di n gs fr o m pr evi o us m o nit ori n g visits a n d a n y s us p ect e d 
i nc o nsist e nc y i n d at a t h at r e q uir es i nv esti g ati o n. All acti v e sit es will h av e a cl os ur e visit. A cl os ur e visit is 
a visit t h at occ urs aft er a sit e’s l ast r e q uir e d f oll o w -u p  visit. Cl os ur e visit acti viti es m ay i ncl u d e s o urc e 
v erific ati o n of t h e d at a a n d cl os ur e of a n y fi n di n gs a n d/ or st u dy -r el at e d activiti es.  St or a g e a n d 
acc o u nt a bility of i nv esti g ati o n al pr o d uct us e d f or t his st u dy will b e ass ess e d a n d m o nit or e d t hr o u g h o ut 
th e st u dy at e ac h sit e.  
1 0  
S T A TI S TI C A L C O N SI D E R A TI O N S   
 
1 0 . 1 
S T A TI S TI C A L A N D A N A L Y TI C A L P L A N S  
B ec a us e t his is a first -i n-h u m a n f e asi bilit y st u dy, n o f or m al St atistic al A n al ysis Pl a n will b e d ev el o p e d.  
1 0 . 2 
S T A TI S TI C A L H Y P O T H E S E S  
B ec a us e t his is a s m all, u n p o w er e d, first-i n-h u m a n  f e asi bilit y st u dy, n o f or m al t ests of h y p ot h esis ar e 
pl a n n e d.  
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
5 9  
1 0 . 3 
A N A L Y SI S D A T A S E T S  
D at a fr o m all e nr oll e d s u bj ects f or w h o m a n i m pl a nt is att e m pt e d will b e i ncl u d e d i n d at a a n alysis. 
C ert ai n ex pl or at ory a n alys es m ay b e c o n d uct e d t h at i ncl u d e o nl y s u bj ects w h o r ec ei v e d a n i m pl a nt, or 
w h o h av e r et ai n e d a n i m pl a nt f or a mi ni m u m p eri o d of ti m e.   
1 0 . 4 
D E S C RI P TI O N O F S T A TI S TI C A L M E T H O D S  
 
1 0 . 4. 1 G E N E R A L A P P R O A C H  
B ec a us e t his is a n u n p o w er e d f e asi bility st u dy, n o f or m al t ests of h y p ot h esis will occ ur.  All o utc o m e 
d at a will b e s u m m ariz e d usi n g a p pr o pri at e d escri ptiv e st atistics ( e. g. m e a n, st a n dar d d e vi ati o n a n d 9 5 % 
c o nfi d e nc e i nt erv als f or c o nti n u o us d at a; fr e q u e ncy distri b uti o ns f or c at e g oric al d at a).  D at a will b e 
s u m m ariz e d i n a m a n n er t h at will pr o vi d e s uffici e nt b asis f or a ris k vs b e n efit ass ess m e nt t o i nf or m 
c o nsi d er ati o ns f or f ut ur e st u dy.  
1 0 . 4. 2 A N A L Y SI S O F T H E P RI M A R Y E F FI C A C Y E N D P OI N T( S)  
T h e pri m ar y e n d p oi nt is  a bi n ar y m e as ur e of at l e ast 2 0 % r e d ucti o n fr o m b as eli n e i n  di ur n al  I O P at six 
m o nt hs.  T his e n d p oi nt will b e d escri pti v ely s u m m ariz e d as a pr o p orti o n of s u bj ects m e eti n g t his 
crit eri o n, al o n g wit h t h e c orr es p o n di n g 9 5 % c o nfi d e nc e i nt erv al.    
Gi v e n t h e s m all s a m pl e siz e of t his st u dy, t h e pri m ary effic ac y e n d p oi nt will b e ev al u at e d s ev er al 
diff er e nt w a ys t o ass ess t h e r o b ust n ess of st u dy c o ncl usi o ns.  O n e a n al ysis will d et er mi n e  w h et h er or 
n ot a s u bj ect is cl assifi e d as s ucc ess ( at l e ast 2 0 % r e d ucti o n i n I O P) b as e d strictly o n t h e b as eli n e a n d 
f oll o w-u p I O P.  A n ot h er a n al ysis will b e c o n d uct e d t h at cl assifi es a n y s u bj ect as a f ail ur e if, at t h e ti m e of 
t h e e n d p oi nt ev al u ati o n, t he s u bj ect:  
•  
is t a ki n g i ncr e as e d gl a uc o m a m e dic ati o n ov er b as eli n e 
•  
h as r e q uir e d gl a uc o m a r e -o p er ati o n  
•  
h as ex p eri e nc e d a cli nic all y si g nific a nt p ost -o p er ati v e hy p ot o ny t h at r es ults i n i nj ur y 
(i. e., n o hy p ot o ny m ac ul o p at h y, asti g m atis m, fl at a nt eri or c h a m b er, c or n e al f ol ds, 
c h or oi d al eff usi o ns, s u pr ac h or oi d al h e m orr h a g e) or r e q uir es i nv asiv e i nt er v e nti o n  
•  
h as b e e n u n a bl e t o r ec ei v e a n i m pl a nt  
•  
h as disc o nti n u e d tri al p artici p ati o n d u e t o t h e i nv esti g ati o n al d evic e  
•  
r e q uir es or al or i ntr av e n o us gl a uc o m a m e dic ati o n 
•  
e x p eri e nc e d a s eri o us d e vic e -r el at e d A E. 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 0  
1 0 . 4. 3 A N A L Y SI S O F T H E S E C O N D A R Y E N D P OI N T( S)  
B ec a us e t his is a n u n p o w er e d f e asi bility st u dy, n o f or m al t ests of h y p ot h esis will b e c o n d uct e d f or t h e 
s ec o n d ary e n d p oi nts.  All s ec o n d ary e n d p oi nts will b e ass ess e d usi n g a p pr o pri at e d escri ptiv e st atistics.   
1 0 . 4. 4 S A F E T Y A N A L Y S E S  
S af et y will b e ass ess e d b y s u m m arizi n g all a dv ers e e v e nts, i ncl u di n g s u m m ari es acc or di n g t o r el at e d n ess 
a n d s eri o us n ess.  
1 0 . 4.5   B A S E LI N E D E S C RI P TI V E  S T A TI S TI C S  
B as eli n e c h ar act eristics a n d s u bj ect d e m o gr a p hics will b e s u m m ariz e d usi n g a p pr o pri at e d escri ptiv e 
st atistics. 
1 0 . 4.6  P L A N N E D I N T E RI M A N A L Y S E S  
 
1 0 . 4.6 . 1 
S A F E T Y R E VI E W  
S af et y will b e ass ess e d o n a n o n g oi n g b asis b y t h e i n d e p e n d e nt M e dic al Dir ect or, S p o ns or , a n d Pri nci p al 
I nv esti g at or. N o f or m al i nt eri m a n al ys es ar e pl a n n e d.   
1 0 . 4.6 . 2 
E F FI C A C Y R E VI E W  
Eff ectiv e n ess will b e i nf or m ally ass ess e d o n a p eri o dic b asis t o e ns ur e a n acc e pt a bl e l e v el of risk f or t h e 
o bs erv e d l e v el of effic ac y.  
1 0. 4. 7  A D DI TI O N A L S U B -G R O U P A N A L Y S E S  
D u e t o t h e s m all ( n = 1 0) s a m pl e siz e, f or m al s u b -gr o u p a n alys es ar e n ot p ossi bl e or pl a n n e d.   
1 0 . 4.8  M U L TI P L E C O M P A RI S O N/ M U L TI P LI CI T Y  
B ec a us e n o f or m al t ests of hy p ot h esis ar e pl a n n e d, t h e n oti o n of ty p e I err or d o es n ot exist a n d 
c o ntr olli n g f or m ulti pl e c o m p aris o ns a n d m ulti plicit y is n ot n ec ess ar y.  
1 0 . 4.9  T A B U L A TI O N O F I N DI VI D U A L R E S P O N S E D A T A  
I n a d diti o n t o t a b ul ar d escri pti v e s u m m ari es of s af et y a n d eff ectiv e n ess d at a, li n e listi n gs of all a dv ers e 
e v e nts a n d k e y eff ecti v e n ess v ari a bil es will pr ovi d e d, by s u bj ect.   
1 0 . 4. 10  
E X P L O R A T O R Y A N A L Y S E S  
T h e a bilit y t o p erf or m f or m al ex pl or at or y a n alys es is li mi t e d b y t h e s a m pl e siz e of t his tri al. All o utc o m e 
d at a will b e s u m m ariz e d usi n g a p pr o pri at e d escri ptiv e st atistics.  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 1  
1 0 . 5 
S A M P L E SI Z E  
T his tri al is a first -i n-h u m a n f e asi bilit y tri al of t h e Br o w n Gl a uc o m a I m pl a nt. N o f or m al t ests of 
hy p ot h esis ar e pl a n n e d, a n d s o s a m pl e siz e is n ot st atistic all y d eri v e d. A t ot al of t e n e nr oll e d a n d 
i m pl a nt e d s u bj ects ar e b eli e v e d t o b e s uffici e nt t o c o nfir m pr ecli nic al fi n di n gs, pr o vi d e evi d e nc e of 
f e asi bilit y of effic acy, a n d d et er mi n e w h et h er or n ot t h e o bs er v e d s af et y pr ofil e j ustifi es f urt h er st u dy.  
1 0 . 6 
M E A S U R E S T O MI NI MI Z E  BI A S  
 
1 0 . 6. 1 E N R O L L M E N T / R A N D O MI Z A TI O N/ M A S KI N G P R O C E D U R E S  
A st u dy s u bj ect w ill b e c o nsi d er e d e nr oll e d i n t h e st u dy u p o n si g ni n g I nf or m e d C o ns e nt. If a n e nr oll e d 
s u bj ect d o es n ot m e et all eli gi bilit y crit eri a, t h e s u bj ect will b e s u bs e q u e ntly wit h dr a w n fr o m t h e st u dy. 
O nly e nr oll e d s u bj ects f or w h o m a n i m pl a nt is att e m pt e d will b e  f oll o w e d a n d r e p ort e d o n. Si nc e t his is 
a si n gl e -ar m f e asi bility st u dy, t h er e will b e n o r a n d o miz ati o n or m as ki n g / bli n di n g pr oc e d ur es.  
1 1  
S O U R C E D O C U M E N T S A N D A C C E S S T O S O U R C E D A T A / D O C U M E N T S  
I nv esti g at ors ar e r e q uir e d t o m ai nt ai n o n fil e t h e acc ur at e, c o m pl et e, a n d c urr e nt r ec or ds r el ati n g t o t his 
i nv esti g ati o n:  
•  
All c orr es p o n d e nc e wit h a n ot h er I nv esti g at or, a n I R B or Et hics C o m mitt e e, Micr o O ptx , a 
m o nit or, or F D A or C o m p et e nt A ut h orit y i ncl u di n g r e q uir e d  r e p orts  
•  
T h e si g n e d CI P wit h a n y a n d all a m e n d m e nts  
•  
T h e a p pr ov e d t e m pl at e of t h e S u bj ect i nf or m e d c o ns e nt f or m  
•  
R ec or ds s h o wi n g r ec ei pt, us e, a n d dis p ositi o n of all d evic es , i ncl u di n g:  
o  D at e, q u a ntit y, a n d s eri al n u m b ers of d evic es r ec eiv e d  
o  N a m es of all  p ers o ns w h o r ec eiv e d, us e d or dis p os e d of e ac h d evic e  
o  D at es a n d s eri al n u m b ers of d e vic es r et ur n e d t o t h e S p o ns or  a n d t h e r e as o n(s) f or 
r et ur n  
•  
I R B or Et hics C o m mitt e e a p pr o v al of t h e CI P a n d a ny a m e n d m e nts a n d r e n e w als  
•  
C o m p et e nt A ut h orit y A p pr o v al i n t h os e c o u ntri es w h er e a p plic a bl e  
•  
T h e I nv esti g at ors’ a gr e e m e nt a n d t h e f e e a gr e e m e nt (s e p ar at e or c o m bi n e d)  
•  
T h e R e p ort of Pri or I nv esti g ati o ns a n d/ or t h e I nv esti g at or’s Br oc h ur e  
•  
T h e i ns ur a nc e c ertific at e   
•  
A ny  d oc u m e nt ati o n pr ovi d e d wit h t h e d evic e  
•  
C u rr e nt c urric ul u m vit a e f or t h e Pri nci p al I nv esti g at or a n d all S u b -I nv esti g at ors  
•  
M o nit ori n g l ett ers (if a p plic a bl e)  
•  
I nt eri m/fi n al r e p orts  
•  
St u dy i niti ati o n f or ms  
•  
S t u dy cl os ur e d oc u m e nts  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 2  
 I n a d diti o n t o t h e st u dy a d mi nistr ativ e d oc u m e nts, S u bj ect r ec or ds s h all b e a p pr o pri at ely fil e d, 
i ncl u di n g t h e f oll o wi n g:  
•  
Si g n e d i nf or m e d c o ns e nt f or ms  
•  
S o urc e d oc u m e nts us e d f or r ec or di n g d at a ( e. g., d e vic e c h ar act eristics at i m pl a nt a n d f oll o w u p)  
•  
R ec or ds of a n y a dv ers e e v e nt , i ncl u di n g s u p p orti n g d oc u m e nt ati o n  
•  
R ec or ds p ert ai ni n g t o S u bj ect d e at hs d uri n g t h e st u dy  
•  
R el ev a nt s o urc e d at a  
•  
A ny ot h er r ec or ds r e q uir e d b y t h e S p o ns or    
•  
D oc u m e nts s h o wi n g t h e d at es a n d r e as o ns f or e ac h d e vi ati o n fr o m t h e CI P  
Micr o O ptx a n d d esi g n at e d p ers o n n el ( e. g. m o nit ors) s h all h a v e acc ess t o all r ec or ds list e d a b o v e, u p o n 
r e q u est. 
1 2  
E T HI C S / P R O T E C TI O N O F  H U M A N S U BJ E C T S  
 
1 2. 1  
I N S TI T U TI O N A L RE VI E W B O A R D (I R B)  
T h e pri m ar y p ur p os e of t h e I R B is t o e ns ur e t h at t h e ri g hts a n d w elf ar e of r es e arc h s u bj ec ts ar e 
a d e q u at el y pr ot ect e d.  I n ex ec uti n g its p ur p os e, t h e I R B h as t h e a ut h orit y t o a p pr o v e, r e q uir e 
m o dific ati o ns t o s ec ur e a p pr o v al, or dis a p pr ov e t his r es e arc h st u dy. Als o, t h e I R B h as a ut h orit y t o 
s us p e n d or t er mi n at e t h e tri al o nc e it is o n g oi n g if it is n ot b ei n g c o n d uct e d i n acc or d a nc e wit h t h e I R B’s 
r e q uir e m e nts, or b ec o m es  ass oci at e d wit h u n ex p ect e d s eri o us h ar m t o s u bj ects.  
Gi v e n t h e e arl y n at ur e a n d d ur ati o n of t his tri al, t h e I R B will f or m ally r e vi e w o n g oi n g d at a ( pr ot oc ol 
d e vi ati o ns, A Es, a n d d e at hs) e v er y six m o nt hs.  S eri o us A dv ers e Ev e nts will b e r e p ort e d t o t h e I R B 
acc or di n g t o t h e I R B’s p olicy.  
1 2 .2  
E T HI C A L S T A N D A R D –  S T A T E M E N T S O F C O M P LI A N C E  
T his cli nic al i n v esti g ati o n s h all b e c o n d uct e d i n acc or d a nc e wit h t h e et hic al  pri nci pl es t h at h a v e t h eir 
ori gi n i n t h e D ecl ar ati o n of H elsi n ki.  
T h e tri al will b e c arri e d o ut i n c o m pli a nc e wit h I S O st a n d ar d 1 4 1 5 5: 2 0 1 1 –  Cli nic al i nv esti g ati o n of 
m e dic al d e vic es f or h u m a n s u bj ects –  G o o d Cli nic al Pr actic e  
T his tri al will b e list e d i n cli nic altri als. g ov pri or t o b e gi n ni n g t h e tri al.    
T his st u dy will n ot b e gi n u ntil all r e q uir e d a p pr o v als a n d f a v or a bl e o pi ni o ns h av e b e e n o bt ai n e d fr o m 
t h e E C a n d ot h er g ov er ni n g r e g ul at or b o di es. All r e q uir e m e nts i m p os e d b y t h e E C or ot h er g ov er ni n g 
b o di es will b e f oll o w e d.  
1 2. 3  
I N F O R M E D C O N S E N T P R OC E S S  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 3  
 
1 2. 3 . 1 C O N S E N T / A S S E N T A N D O T H E R IN F O R M A TI O N A L D O C U M E N T S P R O VI D E D T O 
P A R TI CI P A N T S  
I nf or m e d C o ns e nt is r e q uir e d fr o m all S u bj ects ( or t h eir l e g al r e pr es e nt ati v es) pri or t o t h e S u bj ect’s 
p artici p ati o n i n t h e st u dy.  
Ot h er i nf or m ati o n al m at eri als pr ovi d e d t o st u dy p artici p a nts will i n cl u d e: 
•  
P ati e nt M a n u al –  i m p ort a nt i nf or m ati o n f or tri al p artici p a nts i m pl a nt e d wit h t h e Br o w n 
Gl a uc o m a I m pl a nt, i ncl u di n g c o nt act i nf or m ati o n f or q u esti o ns a n d  c o nc er ns 
•  
P ati e nt C ar d –  M e dic al Al ert p ati e nt i nf or m ati o n c ar d  
1 2. 3 . 2 C O N S E N T P R O C E D U R E S A N D D O C U M E N T A TI O N  
T h e pr oc ess of o bt ai ni n g I nf or m e d C o ns e nt s h all c o m pl y wit h t h e D ecl ar ati o n of H elsi n ki, F D A 2 1 C F R 5 0, 
I S O 1 4 1 5 5-2 0 1 1 a n d a p plic a bl e n ati o n al r e g ul ati o ns (l oc al I R B, Et hics C o m mitt e e a n d/ or R e g ul at or y 
b o di es, as a p plic a bl e). T h e pr oc ess of o bt ai ni n g i nf or m e d c o ns e nt s h all :  
a) A v oi d a n y c o erci o n of or u n d u e i nfl u e nc e of S u bj ects t o p artici p at e,  
b) N ot w ai v e or a p p e ar t o w ai v e su bj ect’s  l e g al ri g hts,  
c) Us e n ati v e l a n g u a g e t h at is n o n-t ec h nic al a n d u n d erst a n d a bl e t o t h e su bj ect or his/ h er l e g al 
r e pr es e nt ati v e,  
d) Pr o vi d e a d e q u at e ti m e f or t h e su bj ect t o c o nsi d er p artici p ati o n a n d as k q u esti o ns if n ec ess ary,  
e) I nf or m e d c o ns e nt s h all a l w a ys b e si g n e d a n d p ers o n ally d at e d by t h e su bj ect or l e g al r e pr es e nt ativ e 
a n d b y t h e I nv esti g at or.  
T h e ori gi n al si g n e d I nf or m e d C o ns e nt m ust b e r et ai n e d o n fil e by t h e I nv esti g at or a n d a c o py giv e n t o 
t h e su bj ect (I nv esti g at or’s r es p o nsi bilit y). 
1 2. 4  
P A R TI CI P A N T  A N D D A T A C O N FI D E N TI A LI T Y  
T hr o u g h o ut t h e st u dy, c o nfi d e nti alit y s h all b e m ai nt ai n e d at all ti m es, by all p arti es i nv ol v e d, a n d all 
d at a s h all b e s ec ur e d a g ai nst u n a ut h oriz e d acc ess. C o nfi d e nti alit y of e ac h su bj ect s h all b e pr es erv e d i n 
r e p orts a n d a n y p u blic ati o n of t h e r es ults. O nl y a ut h oriz e d p ers o n n el a n d t h eir d esi g n e es will h av e 
acc ess t o t h es e c o nfi d e nti al fil es. S u bj ect d at a m ay b e m a d e av ail a bl e t o n ati o n al a n d f or ei g n r e g ul at ory 
a g e nci es, h e alt h or ot h er g o v er n m e nt al a ut h oriti es, u n d er strict c o nfi d e nti alit y c o n diti o n. T h e 
i nv esti g ati o n al sit es s h all e ns ur e t h at d at a ( e. g. w orks h e ets, m e dic al r ec or ds, di git al i m a g es) f or w ar d e d 
t o t h e S p o ns or  d o n ot c o nt ai n a n y S u bj ect i d e ntif yi n g d at a (s uc h as n a m e a n d birt h d at e) , ot h er t h a n t h e 
S u bj ect I D.  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 4  
It is r e q uir e d t h at e C R Fs b e e nt er e d i n t h e el ectr o nic d at a e ntry syst e m pr ovi d e d by t h e S p o ns or . All 
e C R Fs r e q uir e t h e I nv esti g at or’s el ectr o nic si g n at ur e or t h e I nv esti g at or’s d esi g n e e.   
S o urc e d oc u m e nts  —  as p er F D A 2 1 C F R 8 1 2 a n d I S O 1 4 1 5 5 -2 0 1 1  —  ar e pri nt e d, o ptic al or el ectr o nic 
d oc u m e nts i ncl u di n g t h e i nf or m ati o n i n ori gi n al r ec or ds a n d n ec ess ar y f or t h e r ec o nstr ucti o n a n d 
e v al u ati o n of t h e cli nic al i nv esti g ati o n. Ori gi n al s o urc e d at a s h o ul d r e m ai n at t h e i nv esti g ati o n al sit e.  
1 2. 4 .1  R E S E A R C H U S E O F S T O R E D H U M A N S A M P L E S, S P E CI M E N S O R D A T A  
A p artici p ati n g I nv esti g at or s h all pr ovi d e dir ect acc ess t o s o urc e d at a a n d d oc u m e nts f or Tri al -r el at e d 
m o nit ori n g, a u dits, I R B or Et hics C o m mitt e e r evi e w, a n d r e g ul at ory i ns p ecti o n. All su bj ects’ h e alt h 
i nf or mati o n will b e k e pt c o nfi d e nti al i n acc or d a nc e wit h all a p plic a bl e l a ws a n d r e g ul ati o ns. S u bj ects’ 
h e alt h i nf or m ati o n m a y b e us e d t o c o n d uct t his r es e arc h, as w ell as f or a d diti o n al p ur p os es, s uc h as 
o v ers e ei n g a n d i m pr o vi n g t h e p erf or m a nc e of pr o d ucts, n e w  m e dic al r es e arc h a n d pr o p os als f or 
d e v el o pi n g n e w m e dic al pr o d ucts or pr oc e d ur es, a n d ot h er b usi n ess p ur p os es. I nf or m ati o n r ec ei v e d 
d uri n g t h e st u dy will n ot b e us e d t o m ar k et t o su bj ects ; su bj ect n a m es will n ot b e pl ac e d o n a ny m aili n g 
lists or s ol d t o any o n e f or m ar k eti n g p ur p os es.  
1 2. 5  
F U T U R E U S E O F S T O R E D  S P E CI M E N S  
T h er e will b e n o h u m a n s a m pl es or s p eci m e ns c oll ect e d a n d st or e d f or f ut ur e us e i n t his st u dy.   
 
1 3  
D A T A H A N D LI N G A N D R E C O R D K E E PI N G  
 
1 3 .1  
D A T A C O L L E C TI O N A N D M A N A G E M E N T R E S P O N SI BI LI TI E S  
T o e ns ur e d at a q u alit y a n d c o m pl et e n ess, all r e q uir e d d at a will b e r ec or d e d o n st a n d ar diz e d c as e r e p ort 
f or ms (e C R Fs) pr o vi d e d b y t h e S p o ns or . C as e re p ort for ms s h o ul d b e c o m pl et e d acc ur at ely a n d 
c o m pl et el y d uri n g a n d i n a ti m ely m a n n er a ft er a ny tr e at m e nt i n t h e st u dy. T h e Pri nci p al I nv esti g at or or 
a p p oi nt e d d esi g n e e m ust r e vi e w t h e cas e re p ort for ms a n d el ectr o nic ally si g n t h e m c ertifyi n g t h eir 
acc ur ac y.   
Micr o O ptx  f oll o ws a d at a m a n a g e m e nt pl a n w hic h is o n fil e a n d av ail a bl e f or r evi e w. D at a will b e 
c a pt ur e d i n a n el ectr o nic d at a c a pt ur e s yst e m. D at a will b e r evi e w e d r e g ul arly b y b ot h st u dy m o nit ors 
a n d d at a ass oci at es.  D at a q u eri es will b e iss u e d as n e e d e d a n d r e q uir e sit e p ers o n n el t o m a k e 
c orr ecti o ns a n d st at e t h e r e as o n f or t h e m o d ific ati o n. All e ntri es a n d m o dific ati o ns will b e c a pt ur e d i n 
a n el ectr o nic s yst e m a u dit tr ail.  
1 3 .2  
S T U D Y R E C O R D S R E T E N T I O N  
S o urc e d at a is r et ai n e d at t h e cli nic al sit es u ntil c o m pl eti o n of t h e tri al a n d t h e n will b e st or e d f or a 
p eri o d of ti m e as s p ecifi e d by t h e S p o ns or ’s q u alit y s yst e m. 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 5  
1 3 .3  
P R O T O C O L D E VI A TI O N S  
A n I nv esti g at or is r e q uir e d t o c o n d uct t his st u dy i n acc or d a nc e wit h t h e si g n e d I nv esti g at or’s 
A gr e e m e nt, t his i n v esti g ati o n al pl a n, a p plic a bl e l a ws a n d a p plic a bl e n ati o n al r e g ul ati o ns, a n d a ny 
c o n diti o ns of a p pr ov al i m p os e d by t h e r evi e wi n g I R B or Et hics C o m mitt e e a n d r e g ul at or y a g e nc y ( e. g.: 
F D A or C o m p et e nt A ut h orit y).  
Pr ot oc ol d e vi ati o ns ar e a f act of lif e wit h a ny cli nic al tri al. D evi ati o ns m a y b e a ntici p at e d ( e. g.: k n o w n 
d el a y i n a f oll o w u p visit), i n a dv ert e nt ( e. g.: u n pl a n n e d d el a y or miss of a f oll o w u p visit d u e t o a f a mily 
e m er g e nc y), or u n a ntici p at e d o n a n e m er g e ncy b asis ( e. g.: tr a u m a  m a y r e q uir e d e vic e r e m o v al t o 
acc o m m o d at e c o ntr ai n dic at e d pr oc e d ur es). Exc e pt i n e m er g e nc y sit u ati o ns, pr ot oc ol d evi ati o ns 
r e q uir es pri or S p o ns or  a p pr o v al; a n d if t h e d evi ati o n m a y aff ect t h e sci e ntific s o u n d n ess of t h e pl a n or 
t h e ri g hts, s af ety, or w elfar e of su bj ects, pri or I R B or Et hics C o m mitt e e a p pr ov al is r e q uir e d. A n 
I nv esti g at or s h all n otify t h e S p o ns or  a n d t h e r e vi e wi n g I R B or Et hics C o m mitt e e of a n y d evi ati o n fr o m 
t h e i n v esti g ati o n al pl a n t o pr ot ect t h e lif e or p hysic al w ell-b ei n g of a su bj ect i n a n e m er g e ncy. S uc h 
n otic e s h all b e giv e n as s o o n as p ossi bl e, b ut n o l at er t h a n fi v e w orki n g d a ys aft er t h e e m er g e nc y 
occ urr e d. All d e vi ati o ns fr o m t h e i nv esti g ati o n al pl a n m ust b e r e p ort e d t o t h e S p o ns or  t o g et h er wit h t h e 
r e as o n f or t h e d evi ati o n a n d p ossi bl e c orr ectiv e acti o ns f or t h e d evi ati o ns. I n s o m e circ u mst a nc es, t h e 
c e nt er m ay b e r e q uir e d t o n otif y t h e c e nt er’s I R B or Et hics C o m mitt e e, a n d t h e S p o ns or  will n otif y t h e 
a p pr o pri at e r e g ul at ory a g e nci es . 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 6  
1 3 .4  
P U B LI C A TI O N A N D D A T A S H A RI N G P O LI C Y  
P u blic ati o ns a d dr essi n g t h e E arly Bir d St u dy r es ults will b e m a n a g e d b y a p u blic ati o ns c o m mitt e e. 
Micr o O ptx will f or m t h e E arl y Bir d St u dy p u blic ati o ns c o m mitt e e  t o i ncl u d e m e m b ers of Micr o O ptx a n d 
p artici p ati n g I nv esti g at ors. T h e c o m mitt e e s h all elect its c h air at t h e first p u blic ati o ns m e eti n g, w hic h 
will b e h el d n e ar t h e ti m e of st u dy st art. E ac h p artici p ati n g i nstit uti o n m ay pr o vi d e o n e r e pr es e nt ati v e t o 
t h e p u blic ati o ns c o m mitt e e. A d diti o n al m e m b ers m ay b e a d d e d b as e d o n a p pr ov al of t h e c o m mitt ee. 
T h e c o m mitt e e will d e v el o p a p u blic ati o n str at e gy t h at will i ncl u d e a fi n al p u blic ati o n pl a n. T h e sci e ntific 
v ali dit y a n d ti mi n g of p u blic ati o ns will b e ev al u at e d i n or d er t o m axi miz e t h e b e n efits d eriv e d fr o m t h e 
p u blic ati o n of t h e w orl d wi d e cli nic al d at a of t h e E arl y Bir d St u dy. All p u blic ati o ns a n d str at e gy will b e 
r e vi e w e d a n d a p pr o v e d b y t h e P u blic ati o ns C o m mitt e e. I n g e n er al, p u blic ati o ns utilizi n g st u dy d at a will 
b e m a n a g e d as f oll o ws:  
A ut h ors hi p S el ecti o n  
A ut h ors will b e s el ect e d b as e d o n t h e f o ll o wi n g crit eri a: 
•  
T h e q u a ntit y of p ati e nts w h o ar e e nr oll e d i n t h e st u dy, pr ovi d e d t h at q u ality c o m pli a nt d at a 
is c oll ect e d (i. e., d at a t h at is c o m pl et e, acc ur at e a n d r ec eiv e d wit hi n a r e as o n a bl e ti m e 
fr a m e) 
•  
D oc u m e nt e d I nv esti g at ors’ p artici p ati o n i n t h e st u dy d e v el o p m e nt pr oc ess  
•  
T h e q u alit y a n d q u a ntit y of pri or p u blic ati o n hist or y i n g e n er al a n d wit h Micr o O ptx  Cli nic al 
R es e arc h  
•  
At l e ast o n e Micr o O ptx  a ut h or pr ovi di n g s u bst a ntiv e c o ntri b uti o n t o t h e st u dy s h all b e 
c o nsi d er e d 
C o nfi d e nt i alit y 
T h e C o m mitt e e, Micr o O ptx , a n d all I nv esti g at ors a n d a ut h ors will e n s ur e t h at n o i nf or m ati o n w hic h 
w o ul d r ev e al a p ati e nt’s i d e ntit y is us e d i n a ny p u blic ati o n. I nf or m ati o n w hic h c o ul d b e us e d t o est a blis h 
a p ati e nt’s i d e ntity, s h o ul d n ot b e pr ovi d e d  t o Micr o O ptx . A ut h ors a n d Micr o O ptx  will t a k e ev ery 
r e as o n a bl e pr ec a uti o n t o pr ot ect t h e i d e ntit y of p ati e nts e nr oll e d i n t h e tri al. 
R e vi e w a n d C o m m u nic ati o n G ui d eli n es  
I nv esti g at ors will r ec eiv e a c o m m u nic ati o n r e g ar di n g t h e a ut h ors hi p s el ecti o n, t h e p u blic ati o n c o -
a ut h ors , a n d t o w hic h sci e ntific pl atf or m t h e p u blic ati o n will b e s u b mitt e d.  
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 7  
1 4  
S T U D Y A D MI NI S T R A TI O N  
 
1 4 . 1 
S P O N S O R  I N F O R M A TI O N 
Micr o O ptx, I nc  
1 0 6 5 0 C o u nt y R o a d 8 1  
S uit e 1 3 3  
M a pl e Gr ov e, M N  5 5 3 6 9  
8 8 8 -5 9 1 -2 7 8 4  
S p o ns or ’s C o nt act: 
 
 
 
 
 
 
 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 8  
 
1 7  
LI T E R A T U R E R E F E R E N C E S  
1.  A. A. S h a h et al. Bi ol o gic al D e gr a d ati o n of Pl astics -A C o m pr e h e nsi v e R e vi e w, 
Bi ot ec h n ol o g y A d v a nc es 2 6 ( 2 0 0 8) 2 4 6 – 2 6 5  
2.  A dl er’s P h ysi ol o g y of t h e E y e, Cli nic al A p plic ati o n; W M H art, e d. 9 t h e d; St. L o uis, 
M O, 1 9 9 2; p 2 4 8 -2 5 7  
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m o dific ati o n a n d c h ar act eriz at i o n of t h er m o pl astic p ol y ur et h a n e, E ur o p e a n 
P ol y m er J o ur n al ( 2 0 0 9), d oi: 1 0. 1 0 1 6/j. e ur p ol y mj. 2 0 0 9. 0 2. 0 1 1  
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v al v e i m pl a nt i n a d v a nc e d gl a uc o m a. O p ht h al m ol o g y 1 9 9 8; 1 0 5: 1 9 6 8 -1 9 7 6.  
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1 0.  B o d e, G; Cl a usi n g, P; G er v ais, F; et. al.  T h e Utilit y of t h e Mi ni pi g as a n A ni m al 
M o d el i n R e g ul at or y T o xici ol o g y, J o ur n al of P h ar m ac ol o gic al a n d T o xic ol o gic al 
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3 1 4 5 -3 1 6 6, 1 9 9 1.  
1 3.  B u d e nz DL, F e u er WJ, B arti o n K, Sc hiff m a n J, C ost a V P, G o dfr e y D G, B u ys Y M:  
P ost o p er ati v e C o m plic ati o ns i n t h e A h m e d B a er v el dt C o m p aris o n St u d y D uri n g 
Fi v e Y e ars of F oll w -u p.  A m J O p ht h al m ol 1 6 3: 7 5 -8 2, 2 0 1 6.  
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D e vic es; Bi o -M at eri als a n d Pr ot ot y pi n g A p plic ati o ns i n M e dici n e; p p 2 7 -4 8; 
S pri n g er , 2 0 0 8  
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M:  S h u nts t o Di v ert A q u e o us H u m or t o Dist a nt E pit h eli al iz e d C a viti es Aft er 
K er at o pr ost h esis S ur g er y.  J Gl a uc o m a 1 9: 1 1 1 -1 1 5, 2 0 1 0.  
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J Cli n P at h ol. 1 9 7 9 N o v; 3 2( 1 1): 1 1 8 4– 1 1 8 7  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
6 9  
1 8.  Et hi er C R, K a m m R D, J o h ns o n M, P a v o o A F, A n d ers o n PJ:  F urt h er St u di es o n t h e 
Fl o w of A q u e o us H u m or t hr o u g h Micr o p or o us Filt ers.  I n v est O p ht h al m ol Vis Sci 
3 0: 7 3 9 -7 4 6, 1 9 8 9.  
1 9.  G e d d e SJ, Sc hiff m a n J C, F e u er WJ, H er n d o n L W, Br a n dt J D, B u d e nz DL:  
Tr e at m e nt O utc o m es i n t h e T u b e V ers us Tr a b ec ul ect o m y ( T V T) St u d y Aft er Fi v e 
Y e ars of F oll o w -u p.  A m J O p ht h al m ol 1 5 3: 7 8 9 -8 0 3, 2 0 1 2.  
2 0.   G o el, V; et. al; B asic Sci e nc e S y m p osi u m III: A ni m al M o d els f or Ort h o p a e dic 
I m pl a nt E v al u ati o n; I nt er n ati o n al J o ur n al of S pi n e S ur g er y;  V ol 2; Iss u e 4; 2 0 1 7 
2 1.  G o oc h,J; W; H a g e n -P ois e uill e E q u a ti o n; E nc ycl o p e dic Dicti o n ar y of P ol y m ers;  p p 
3 5 5 -3 5 5; S pri n g er N e w Y or k; 2 0 1 1  
2 2.  Gr a nt W M, B ur k e J F:  W h y D o S o m e P e o pl e G o Bli n d fr o m Gl a uc o m a ?  
O p ht h al m ol o g y 8 9: 9 9 1 -9 9 8, 1 9 8 2.  
2 3.   G u pta A K. Cli nical o p ht hal m ol o g y: c o nte m p orar y pers pecti ves. Else vier I n dia; 2 0 0 9. 3 2 8 -3 2 9  
2 4.  Hac kett R B, Mc D o nal d T O. 1 9 9 1. E ye irritati o n. I n: A d va nces i n M o der n T o xic ol o g y: 
Der mat o xic ol o g y. 4 t h e d. ( Marz ulli F, Mai bac h H, e ds.). Was hi n gt o n, D C: He mis p here 
P u blis hi n g C or p orati o n, 7 4 9 – 8 1 5  
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Fri m at J, H e n gstl er J G, N e y er A, T hri el C, W est J:  Hi g h fi d elit y n e ur o n al n et w or ks 
f or m e d b y pl as m a m as ki n g wit h a bil a y er m e m br a n e.  L a b C hi p 1 1: 2 7 6 3-2 7 7 1, 
2 0 1 1.  
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M os b y Y e ar B o o k.  
2 7.  H el m ut H, A h m e d I K, Gris a nti S, et al. E arl y p ost o p er ati v e s af et y a n d s ur gic al 
o utc o m es aft er i m pl a nt ati o n of a s u pr ac h or oi d al micr o -st e nt f or t h e tr e at m e nt 
of o p e n -a n gl e gl a uc o m a c o nc o mit a nt wit h c at ar act s ur g er y. J C at ar act R efr act 
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2 8.  H oll y, F; B asic as p ects of c o nt act l e ns bi oc o m p ati bilit y, C oll oi ds a n d S urf ac es; 
V ol u m e 1 0, P a g es 3 4 3 – 3 5 0, Els e vi er, 1 9 8 4  
2 9.  H u W D, Pr o MJ, F u d e m b er g SJ, M ost er M R.; E x pl a nt ati o n of t h e n o v el A h m e d 
gl a uc o m a v al v e M 4 i m pl a nt.; J Gl a uc o m a. 2 0 1 5 F e b; 2 4( 2): e 1 -4.  
3 0.  I v ers o n S M, Sc h ultz S K, S hi W, Fr e ur WJ, Gr e e nfi el d D S: Eff ecti v e n ess of Si n gl e-
Di git I O P T ar g ets o n D ecr e asi n g Gl o b al a n d L oc aliz e d Vis u al Fi el d Pr o gr essi o n 
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3 1.  J a nz, J. K; et. A l. Q u alit y of Lif e i n Ne wl y Di a g n ose d  Gl a uc o m a P atie nts ; 
O p ht h al m ol o g y V ol u m e 1 0 8, N u m b er 5, M a y 2 0 0 1  
3 2.  J a nz, J. K; et. A l. Q u alit y of Lif e i n N e wl y Di a g n os e d Gl a uc o m a P ati e nts; 
O p ht h al m ol o g y V ol u m e 1 0 8, N u m b er 5, M a y 2 0 0 1  
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cli nic al a p plic ati o n. St. L o uis, M O: M os b y. 
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( 2 0 0 7). S y nt h esis a n d C h ar act eriz ati o n of S e g m e nt e d P ol y( est er ur et h a n e ur e a) 

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
7 0  
El ast o m ers f or B o n e Tiss u e E n gi n e eri n g. Act a Bi o m at eri ali a, V ol. 3, N o. 4, (J ul y 
2 0 0 7), p p. 4 7 5 – 4 8 4, I S S N 1 7 4 2 -7 0 6 1  
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bl o o d fl o w a n d a q u e o us h u m or pr o d ucti o n. Pr o gr ess i n R eti n al a n d E y e 
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p ol y et h yl e n e gl yc ol micr o - a n d n a n oc h a n n els b y ultr a vi o l et-assist e d irr e v ersi bl e 
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3 7.  K o h -G u n K, R e vzi n A, Si m o ni a n A, R e e v er T, Pis h k o M:  C o ntr ol of M a m m ali a n 
C ell a n d B act eri a A d h esi o n o n S u bstr at es Micr o p att er n e d wit h P ol y( et h yl e n e 
gl yc ol) H y dr o g els.  Bi o m e d Micr o d e vic es 5 : 1 1 1-1 9, 2 0 0 3.  
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& K ur o y a n a g y, Y., ( 2 0 0 1). Pr e p ar ati o n of W o u n d Dr essi n g Usi n g H y dr o g el 
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(Jul y 2 0 0 1), p p. 4 -6, I S S N 0 9 7 1 -1 1 9 8  
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2 2( 1 0): 3 7 7 -3 8 1  
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a n d Bi otri b ol o g y 1 ( 2 0 1 5) 1 6 1 – 1 7 6 1 6 2  
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O p ht h al m ol 6 0: 2 9 0 -2 9 4, 1 9 5 8.  
4 3.  Mc K e e n, L W Pl astics Us e d i n M e dic al D e vic es; H a n d b o o k of P ol y m er A p plic ati o ns 
i n M e dici n e a n d Me dic al D e vic es. 2 0 1 4  Els e vi er  
4 4.   Mc M e n a mi n, P; St e pt o, R; N or m al A n at o m y of t h e A q u e o us H u m or O utfl o w 
S yst e m i n t h e D o m estic Pi g E y e, J A n at, 1 9 9 1, 1 7 8, 6 5 -7 7  
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A ni m al Pr actic e, N o v e m b er 2 0 1 0  
4 6.   M y u n g D, D u h a m el P E, et al:  D e v el o p m e nt of H y dr o g el -B as e d 
K er at o pr ost h es es: A M at eri als P ers p ecti v e.  Bi ot ec h n ol Pr o g 2 4: 7 3 5 -7 4 1, 2 0 0 8.  
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1 9 7 8, p p. 3 -7 9.  
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Mi ni pi g; Sc a n d J L a b A ni m al Sci; N o. 1; 2 0 0 5 V ol 3 2, 9 -1 6  
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3 4 3 -3 5 1  
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I nv est O p ht h al m ol Vis Sci, 2 0 0 2, 4 3( 8) 2 5 2 9 -2 5 3 2  

E arly BI R D  
V ersi o n 9. 0  
Pr ot oc ol 4 0 3 9  
2 7 J A N 2 0 1 9  
T h e c o nt e nts of t his d oc u m e nt ar e c o nfi d e nti al a n d ar e n ot t o b e r e pr o d uc e d or m a d e a v ail a bl e t o t hir d p arties 
wit h o ut pri or c o ns e nt fr o m Micr o O ptx,  a n d ar e n ot t o b e us e d i n a n y u n a ut h oriz e d w a y.  
 
 
7 1  
5 2.  P et ers D, B e n gtss o n B, H eijl A:  Lif eti m e Ris k of Bli n d n ess i n O p e n -A n gl e 
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n o n -bi of o uli n g p ol y et h yl e n e gl yc ol micr o - a n d n a n oc h a n n els b y ultr a vi ol et -
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6 2.  T h e A GI S I n v esti g at ors: T h e A d v a nc e d Gl a uc o m a I nt er v e nti o n St u d y ( A GI S): 7. 
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6 3.  T h e C oll a b or ati v e N or m al -T e nsi o n Gl a uc o m a St u d y Gr o u p ( C N T G S Gr o u p): T h e 
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Pr ess, p p 8 -8,  2 0 1 3 a n d ot h ers  
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m ol ec ul es  R e vi e w Articl e ; A d v a nc e d Dr u g D eli v er y R e vi e ws, V ol u m e 1 6, Iss u es 
2 – 3, S e pt e m b er 1 9 9 5, P a g es 1 5 7 -1 8 2  
6 6.  Z h a n g M, D es ai T, F err ari M:  Pr ot ei ns a n d c ells o n P E G i m m o biliz e d silic o n 
s urf ac es.  Bi o m at eri als 1 9: 9 5 3-9 6 0, 1 9 9 8.  
6 7.  Z h a n g X, Li Q, Z h o u H, W a n g H, Z h a n g Z, H a n Z, Z o u H:  I n vi v o cr oss -s ecti o n al 
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c o h er e nc e t o m o gr a p h y.  I n v est O p ht h al m ol Vis Sci 5 2: 7 7 8 7 -7 7 9 1, 2 0 1 1.