A Prospective Controlled Multi-Center Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
Phase: NA
Conditions: Aphakia, Cataract
Sponsor: RxSight, Inc.

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L    
P A G E 1 
 
 
 
 
 
P R O T O C O L C S P - 0 3 4 
 
A P R O S P E C TI V E C O N T R O L L E D  M U L TI- C E N T E R C LI NI C A L S T U D Y T O 
E V A L U A T E T H E S A F E T Y A N D E F F E C TI V E N E S S O F P E R F O R MI N G 0. 5 0 
DI O P T E R A S TI G M A TI S M  C O R R E C TI O N O N  T H E C O M M E R CI A L L Y 
A V AI L A B L E R X SI G H T LI G H T A D J U S T A B L E L E N S ( L A L)  
 
 
R x Si g ht, I nc.  
1 0 0 C ol u m bi a, S uite 1 2 0  
Alis o Viej o, C A 9 2 6 5 6  
 
V e rsi o n 0 4 
M a y 2 3 , 2 0 19  
 
 
 
 
 
 
 
I h a v e re a d a n d a gre e t o f oll o w t h e pr oc e d ures as o utli n e d i n t his pr ot o c ol. 
 
T his pr ot o c ol c o ntai ns c o nfi de ntial pr o prietar y i nf or mati o n wit h res p e ct t o R x Si g ht pr o d u cts 
a n d cli nic al trials.  I a gre e t o h ol d t his i nf or m ati o n i n c o nfi d e nc e a n d n ot t o dis cl os e it t o a n y 
t hir d p arties f or a p eri o d of fi ve y e ars fr o m t h e d ate of t his a gre e m e nt, or u ntil t his 
i nf or m ati o n b e c o m es a m atter of p u blic k n o wle d ge t hr o u g h n o a cti o n or f ail ure o n m y p art t o 
m ai ntai n its c o nfi d e ntialit y.  
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
  Site N a m e  
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
  Si g n at ur e  
  D ate  
 
 
 
NCT04005586

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L    
P A G E 2 
 
T A B L E O F C O N T E N T S 
 
P A G E  
1  
S T U D Y S Y N O P SI S  ...............................................................................................5  
1. 1  S T U D Y O BJ E C TI V E  .........................................................................................5  
1. 2  S T U D Y P O P U L A TI O N .......................................................................................5  
1. 3  S T U D Y D E S I G N  ...............................................................................................5  
1. 4  IN C L U SI O N C RI T E RI A  .....................................................................................7  
1. 5  E X C L U SI O N C RI T E RI A  ....................................................................................8  
1. 6  O U T C O M E P A R A M E T E R S  ..............................................................................1 0  
1. 7  E X A MI N A TI O N S C H E D U L E  ............................................................................1 0  
1. 8  C LI NI C A L P A R A M E T E R S : .............................................................................1 0  
2  
I N T R O D U C TI O N A N D R A TI O N A L E  ..............................................................1 4  
2. 1  C LI NI C A L S T U DI E S P E R F O R M E D WI T H P RI O R V E R SI O N O F T H E L I G H T 
A D J U S T A B L E L E N S A N D L I G H T D E LI V E R Y D E VI C E  .......................................1 4  
3  
S T U D Y O B J E C TI V E  ..........................................................................................1 6  
4  
S T U D Y D E SI G N  .................................................................................................1 6  
5  
O U T C O M E P A R A M E T E R S  ..............................................................................1 7  
5. 1  E F F E C TI V E N E S S P A R A M E T E R  .......................................................................1 7  
5. 2  S A F E T Y P A R A M E T E R S  ..................................................................................1 8  
6  
S T U D Y P O P U L A TI O N  ......................................................................................1 8  
6. 1  IN C L U SI O N C RI T E RI A  ...................................................................................1 8  
6. 2  E X C L U SI O N C RI T E RI A  ..................................................................................1 9  
7  
S T U D Y M A T E RI A L S A N D M E T H O D S ............................................................2 1  
7. 1  D E VI C E D E S C RI P TI O N  ..................................................................................2 1  
7. 1. 1  R x Si g ht Li g ht A dj ust a ble I ntr a oc ul a r Le ns ....................................2 1  
7. 1. 2  Li g ht D eli v er y D e vic e ( L D D) ...........................................................2 2  
7. 1. 3  Tr e a t me nt Co nt a ct Le ns..................................................................2 3  
7. 1. 4  U V  Pr ote cti ve E ye w e a r ...................................................................2 3  
7. 1. 5  D e v ice M a n uf a ct ure r.......................................................................2 4  
7. 1. 6  I n dic a ti o ns f o r Us e ( N o c h a n ge c o m p a r e d t o p m a a p pr o v al) ..........2 4  
7. 2  S U B J E C T E N T R Y ...........................................................................................2 5  
7. 3  L I G H T T R E A T M E N T P R O C E D U R E  .................................................................2 6  
7. 4  P O S T P O N E M E N T O F L I G H T T R E A T M E N T P R O C E D U R E (S ) ..............................2 7  
7. 5  R E Q UI R E M E N T S F O R A D DI TI O N A L T E S TI N G  .................................................2 7  
7. 6  P R O C E D U R E P R E P A R A TI O N  ..........................................................................2 8  
7. 7  A D J U S T M E N T P R O C E D U R E (S ) .......................................................................2 9  

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L    
P A G E 8 
 
i ns erti o n d e vic e ( Nic h a mi n III F ol d a ble Le ns I ns erter wit h Nic h a mi n 
II F ol d a ble Le ns I ns erti o n F orc e ps); 
o  H a v e  c o nfir m e d t h at t h e p atie nt w as wit hi n t h e i nte n de d p o p ulati o n as 
s p e cifie d i n t h e I n dic ati o ns f or Us e state m e nt  
•  T h e p atie nt re c ei v e d t h e F D A -a p pr o v e d p atie nt i nf or mati o n b o o klet pri or t o L A L 
i m pla ntati o n. 
•  T h e p atie nt re c ei v e d a n d w as trai n e d i n us e of t h e U V s p e ctacles t h at are i n 
c o m plia n c e wit h all F D A la b eli n g.  
•  A st u d y e y e i m pla nte d wit h t h e P M A a p pr o v e d L A L t h at h as n ot u n d er g o n e a n y 
pre vi o us L D D tre at m e nts.  
•  A st u d y e y e t h at w as i m pla nte d wit h t h e P M A a p pr o v e d L A L b et w e e n 1 7 -2 4 d a ys 
pri or t o St u d y Visit # 1/ A dj ust m e nt # 1.  
•  A st u d y e y e wit h  m a nif est refra cti o n c yli n d er of 0. 5 0 D m e as ure d b y t w o i n d e p e n de nt 
e x a mi n ers at t h e A dj ust m e nt # 1 visit pri or t o t h e first li g ht a dj ust m e nt tre at m e nt.  
•  S i g n a writte n I nf or m e d C o ns e nt f or m a n d b e willi n g t o re c ei v e li g ht tre at m e nt f or 
t h eir 0. 5 0 D of c yli n d er. 
• Bet w e e n t h e a ges of 4 0 a n d 8 0 i n cl usi ve o n t h e d a y t h e  i nf or m e d c o ns e nt f or m is 
si g n e d. 
• St u d y e y e wit h b est c orre cte d dista n c e vis u al a c uit y ( B C D V A) of  2 0/ 2 0 or b etter  
m e as ure d at t h e A dj ust m e nt # 1 visit  pri or t o t h e first li g ht a dj ust m e nt tre at m e nt.   
• St u d y e y e wit h c le ar i ntrao c ular m e dia . 
• G o o d visi o n i n t h e f ell o w e y e wit h B C D V A 2 0/ 4 0  or b etter.  
• Willi n g  a n d a ble t o c o m pl y wit h t h e re q uire m e nts f or st u d y s p e cific pr oc e d ures a n d 
visits.  
• St u d y e y e wit h a v era ge dilate d p u pil dia m eter of ≥7. 0 m m.  
 
1. 5  
E X C L U SI O N C RI T E RI A  
• C li nic all y si g nific a nt dr y e y e s y n dr o m e ( D E S) i n t h e st u d y e y e. 
• Pre- e xistin g m a c ular dis e as e i n t h e st u d y e y e . 
• R eti n al d e ge n erati v e dis or d er t h at is e x p e cte d t o c a use f ut ure visi o n l oss i n t h e 
st u d y e y e. 
• D ia b etes wit h a n y e vi d e n c e of reti n o p at h y i n t h e st u d y e y e.   
• E vi d e n c e of gla u c o mat o us o ptic n e ur o pat h y  i n t h e st u d y e y e.    
• H ist or y of u v eitis i n t h e st u d y e y e.    
• Si g nific a nt a nteri or s e g m e nt p at h ol o g y, s u c h as r u b e osis iri dis, a niri dia, or iris 
c ol o b o m a  i n t h e st u d y e y e. 
• C or n e al p at h ol o g y t h at  is eit h er pr o gressi v e or s ufficie nt t o re d u c e B C DV A t o 
w ors e t h a n 2 0/ 2 0 i n t h e st u d y  e y e. 
• A n y c or n e al d ystr o p h y i n cl u di n g b as e m e nt m e m bra n e d ystr o p h y i n t h e st u d y  
e y e.  

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L    
P A G E 9 
 
• K erat o c o n us or s us pe cte d  of h a vi n g k erat o c o n us i n t h e st u d y  e y e. 
• H as u n d er g o n e pre vi o us  c or ne al or i ntra o c ular s ur ger y i n t h e st u d y e y e , e x ce pt 
f or t h e c atara ct s ur ger y a n d e y es wit h pre vi o us pter y gi u m  e xcisi o n are 
p er mitte d as l o n g as t h e pter y gi u m di d n ot e xte n d m ore t h a n 2 m m  o nt o t h e 
c or n e a fr o m t h e li m b us .  
• S u bje cts wit h s eri o us c o -m or bi d c o n diti o ns t h at i n t h e j u d g m e nt of t h e i n v esti gat or 
m a k es i n cl usi o n i n t h e st u d y n ot i n t h e b est i nterest of t h e s u bje ct.  
• S u bje cts ta ki n g s yste mic m e dic ati o n t h at m a y i n creas e s e nsiti vit y t o U V li g ht s u c h as 
tetra c y cli n e, d o x yc y cli n e, ps orale ns, a mi o d ar o n e, p h e n ot hia zi nes, c hl or o q ui ne, 
h y dr o c hl or ot hia zi d e, h y p erici n, k et o pr ofe n, pir o xica m, l o m efl o xa ci n, a n d 
m et h o xs ale n. L D D tre at m e nt i n p atie nts ta ki n g s u c h m e dic ati o ns m a y le a d t o 
irre v ersi ble p h ot ot o xic d a m a ge t o t h e e y e. T his is o nl y a p artial list of 
p h ot os e nsitizi n g m e dic ati o ns. Ple as e e v al u ate all m e dic ati o ns t h at t h e p atie nt is ta ki n g 
f or t his eff e ct pri or t o c o nsi d erati o n f or i m pla ntati o n.  
• S u bje cts ta ki n g a s yste mic m e dic ati o n t h at is c o nsi d ere d t o xic t o t h e reti n a s u c h as 
ta m o xif e n. 
• S u bje c ts w h o t h e d o ct or b elie v es will b e u n a ble t o m ai ntai n ste a d y fi xati o n t h at is 
n e c ess ar y f or c e ntrati o n of t h e L D D li g ht tre at m e nt i n t h e st u d y  e y e.  
• Irre g ular asti g m atis m i n t h e st u d y e y e . 
•  H ist or y of o c ular h er p es si m ple x vir us i n t h e st u d y e y e .  
•  S u bje ct w h o h as p artici p ate d wit hi n a n ot h er o p ht h al mic cli nic al trial wit hi n t h e last 3 
m o nt hs.  
•  S ut ures us e d at t h e ti m e of s ur ger y t o cl os e t h e i n cisi o n w o u n d i n t h e st u d y e y e . 
•  A st u d y e y e at ti m e of s cre e ni n g n ote d  wit h a n o c ular a d vers e e v e nt t h at c o ul d b e 
n e gati v el y i m p a cte d b y li g ht tre at m e nt or n e gati v el y i m p a ct t h e effe cti v e ness or 
s af et y of a li g ht tre at m e nt. T his i n cl u d es c or ne al e d e m a a n d s u p erficial p u n ctate 
k eratitis ( S P K) ( Gra d e 3 ( m o d erate) or m ore s e v ere)), reti n al c o n diti o ns i n cl u di n g 
dia b etic reti n o p at h y a n d c yst oi d m a c ular e d e ma, e pit helial d efe ct, a n d 
e n d o p ht h al mitis.  
•  A st u d y e y e wit h a n y o n g oi n g o c ular a d vers e e v e nt . 
•  A st u d y e y e at ti m e of s cre e ni n g n ote d wit h e vi d e nc e of pre mat ure 
p h ot o p ol y m eriz ati o n as e vi d e n c e d as a z o n e o n t h e le ns s urfa c e.  
•  A st u d y e y e at ti m e of s cre e ni n g n ote d wit h a n y e vi d e n ce of p osteri or c a ps ular 
o p a cit y ( P C O).  
 
 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L    
P A G E 1 1  
 
4.  C o m plia n c e wit h U V s p e cta cles  
5.  A ut orefra cti o n  
6.  C or n e al T o p o gra p h y  
7.  M o n o c ular U C D V A   
8.  Ma nif est Refra cti o n  
9.  M o n o c ular b est c orre cte d dista n c e vis u al a c uit y ( B C D V A)  
 
 
1 2.  I ntra o c ular press ure 
1 3.  Slit  La m p E x a mi n ati o n  
1 4.  F u n d us E x a mi n ati o n   
1 5.  Dilate d p u pil dia m eter  
1 6.  S p e ctral D o m ai n O C T ( if n e e d e d) 
1 7.  A d v ers e E v e nt  
 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L    
P A G E 1 2  
 
A B B R E VI A TI O N S  
A D E  
A d v ers e D e vic e Effe ct  
A E  
A d v ers e E v e nt  
B C D V A  
Best  C orre cte d Dista n c e Vis u al A c uit y  
C C C  
C o nti n u o us Circ ular Ca ps ul or he xis  
C D R H  
Ce nter f or D e vic es a n d Ra di ol o gic al H e alt h  
C F R  
C o d e of Fe d eral Re g ulati o ns  
CI  
C o nfi d e n ce I nter v al  
C R F  
Cas e Re p ort F or m  
C R O  
C o ntra ct Res e arc h Or ga niz ati o n  
C T S  
Cli nic al Trial S uite  
D  
Di o pter  
D D  
D e vic e D eficie n c y  
D E S  
Dr y E y e S y n dr o m e  
D E Q  
D ef o c us E q ui v ale nt  
E D C  
Ele ctr o nic D ata Ca pt ure  
E T D R S  
Earl y Tre at m e nt Dia b etic Reti n o p at h y St u d y  
E V  
Err or V e ct or  
F D A  
F o o d a n d Dr u g A d mi nistrati o n  
G C P  
G o o d Cli nic al Pra ctic e  
I C D 
I nf or m e d C o nse nt D o c u m e nt 
I D E 
I n v esti gati o n al D e vic e E x e m pti o n 
I O L 
I ntra o c ular Le ns 
I O P 
I ntra o c ular Press ure 
I R B 
I nstit uti o n al Re vie w B o ar d 
I R C 
I nte n d e d Refra cti v e C orre cti o n  
I S O 
I nter n ati o n al Or ga niz ati o n f or Sta n d ardiz ati o n 
I T T 
I nte nt T o Tre at 
L A L  
R x Si g ht Li g ht A dj usta ble Le ns  
L D D  
Li g ht D eli v er y D e vic e  
M R  
Ma nif est Refra cti o n  
M R C Y L  
Ma nif est Refra cti o n C yli n d er  
M R S E  
Ma nif est Refra cti o n S p h eric al E q ui vale nt  
O C T  
O ptic al C o h ere n c e T o m o gra p h y  
P C O  
P osteri or Ca ps ular O p a cit y  
P D  
Pr ot o c ol D e viati o n  
P HI  
Pr ote cte d H e alt h I nf or m ati o n  
P M A  
Pre m ar k et A p plic ati o n  

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L    
P A G E 1 3  
 
S A E  
Seri o us A d v ers e E v e nt  
S A P  
Statistic al A n al ysis Pla n  
S D  
Sta n d ar d D e viati o n  
S D T  
S o urc e D o c u m e nt Te m plate  
S E  
S p h eric al E q ui v ale nt  
SI R C  
S ur gic al I n d u c e d Refra cti v e C orre cti o n  
S P E  
Saf et y a n d Perf or m a n ce E n d p oi nts  
S P K  
S u p erficial P u n ctate K eratitis  
S SI  
Se c o n d ar y S ur gic al I nter v e nti o n  
U A D E  
U n a ntici p ate d A d v ers e D e vice Effe ct  
U C D V A  
U n c orre cte d Dista n c e Vis u al A c uit y  
U V  
Ultra vi olet  
V A  
Vis u al a c uit y  
 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 1 5  
 
 
C o- pri m ar y effe cti v e n ess e n d p oi nts i n cl u de d p erc e nt re d u cti o n i n m a nifest c yli n d er, p erc e nt m e a n 
a bs ol ute re d u cti o n i n m a ni f est refracti o n s p h eric al e q ui vale nt ( M R S E), a n d r otati o n of t h e L A L. 
All pri m ar y eff ecti v e ness e n d p oi nts c o m p are d pre -a dj ust m e nt ( L A L) or 1 7 -2 1 d a ys ( C o ntr ol) t o 6 
m o nt hs p ost o p erati v el y a n d t h e first t w o e n d p oi nts c o m pare d res ults b et w ee n t h e L A L a n d C o n trol 
gr o u ps. All t hre e c o -pri m ar y effe cti v e ness e n d p oi nts w ere m et wit h a p -v al u e < 0. 0 0 0 1. T h e 
diff ere nc e i n m e a ns f or p erc e nt re d u cti o n i n m a nifest c yli n d er w as 5 4. 7 %, wit h a p -v al u e < 0. 0 0 0 1. 
T h e diff ere n ce i n m e a ns f or p erc e nt re d u cti o n i n a bs ol ute M R S E w as 4 1. 1 % wit h a p -v al u e 
< 0. 0 0 0 1. R otati o n of t h e L A L of ≤5 d e gre es w as o bs er ve d i n 9 6. 1 % of L A L i m pla nte d e y es wit h 
b ot h t h e u p p er a n d l o w er b o u n d of t h e 9 5 % c o nfi d e n c e i nter v al e x ce e di n g t h e re q uire me nt of 9 0 %.  
 
1 0 0 % of e y es i n b ot h t h e L A L a n d C o ntr ol gr o u ps h a d B S C V A of 2 0/ 4 0 or b etter, e x c ee di n g t h e 
hist oric gri d rate of 9 2. 5 % (I S O 1 1 9 7 9 -7). T h e i n ci d e nc e of si g ht -t hre ate ni n g c o m plic ati o ns a n d 
a d v ers e e v e nts f or t h e L A L a n d C o ntr ol gr o u ps w ere als o b el o w t h e t hres h ol d rates c alc ulate d 
fr o m t h e 1-y e ar hist oric al gri d f or i ntra o c ular le ns es (I S O 1 1 9 7 9 -7, O p ht h al mic i m pla nts - 
I ntra o c ular le ns es- Part 7: Cli nic al i n v esti gati o ns)  e x c e pt f or t h e c ate g or y of Se c o n d ar y S ur gic al 
I nter v e nti o ns ( S SI), w hic h w as si g nific a ntl y hi g h er t h a n t h e hist oric al rate ( p <. 0 5). 
 
O n N o v e m b er 2 2, 2 0 1 7, t h e Ce nter f or D e vic es a n d Ra di ol o gic al H e alt h ( C D R H) of t h e F o o d a n d 
Dr u g A d mi nistrati o n ( F D A) a p pr o v e d R x Si g ht’s pre m ar ket a p pr o val a p plic ati o n ( P M A) f or t h e 
Li g ht A dj usta ble Le ns ( L A L) a n d Li g ht D eli v er y D e vic e ( L D D) s yste m. T his s yste m is i n dic ate d 
f or t h e re d u cti o n of resi d u al asti g m atis m t o i m pr o v e u n c orrecte d vis u al a c uit y after re m o v al of t h e 
c atara ct o us n at ural le ns b y p ha c oe m ulsific ati o n a n d i m pla ntati o n of t h e i ntra o c ular le ns i n t h e 
c a ps ular b a g; i n a d ult p atie nts:  
•  Wit h  pre-e xisti n g c or n e al asti g m atis m of ≥ 0. 7 5 di o pters  
•  Wit h o ut pre -e xisti n g m a c ular dis e as e  
 
T h e s yste m als o re d u c es t h e li k eli h o o d of cli nic all y si g nifica nt resi d ual s p h eric al refra cti ve err ors.  
 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 1 9  
 
•  T h e p atie nt re c ei v e d a n d w as trai n e d i n us e of t h e U V s p e ctacles t h at are i n c o m plia nc e 
wit h all F D A la b eli n g.  
•  A st u d y e y e i m pla nte d wit h t h e P M A a p pr o v e d L A L t h at h as n ot u n d er g o n e a n y pre vi o us 
L D D tre at m e nts.  
•  A st u d y e y e t h at w as i m pla nte d wit h t h e P M A a p pr o v e d L A L b et w e e n 1 7 -2 4 d a ys pri or t o 
St u d y Visit # 1/ A dj ust m e nt # 1.  
•  A st u d y e y e wit h  m a nif est refra cti o n c yli n d er of 0. 5 0 D m e as ure d b y t w o i n d e p e n de nt 
e x a mi n ers at t h e A dj ust m e nt # 1 visit pri or t o t h e first li g ht a dj ust m e nt tre at m e nt.  
•  S i g n a writte n I nf or m e d C o ns e nt f or m a n d b e willi n g t o re c ei v e li g ht tre at m e nt f or t h eir 
0. 5 0 D of c yli n d er.  
• Bet w e e n t h e a ges of 4 0 a n d 8 0 i n cl usi ve o n t h e d a y t h e  i nf or m e d c o ns e nt f or m is si g n e d. 
• St u d y e y e wit h b est c orre cte d dista n c e vis u al a c uit y ( B C D V A) of  2 0/ 2 0 or b etter  m e asure d 
at t h e A dj ust m e nt # 1 visit  pri or t o t h e first li g ht a dj ust m e nt tre at m e nt .   
• St u d y e y e wit h c le ar i ntrao c ular m e dia . 
• G o o d visi o n i n t h e f ell o w e y e wit h B C D V A 2 0/ 4 0 or b etter.  
• Willi n g  a n d a ble t o c o m pl y wit h t h e re q uire m e nts f or st u d y s p e cific pr oc e d ures a n d visits.  
• St u d y e y e wit h a v era ge dilate d p u pil dia m eter of ≥7. 0 m m.  
 
6. 2  
E X C L U SI O N C RI T E RI A  
 
•  Cli nic all y si g nific a nt dr y e y e s y n dr o m e ( D E S) i n t h e st u d y e y e.  
• Pre -e xisti n g m a c ular dis e as e i n t h e st u d y e y e.  
• R eti n al d e ge n erati v e dis or d er t h at is e x p e cte d t o c a use f ut ure visi o n l oss i n t h e 
st u d y e y e. 
• D ia b etes wit h a n y e vi d e n c e of reti n o p at h y i n t h e st u d y e y e.   
• E vi d e n c e of gla u c o mat o us o ptic n e ur o pat h y  i n t h e st u d y e y e.    
• H ist or y of u v eitis i n t h e st u d y e y e.    
• Si g nific a nt a nteri or s e g m e nt p at h ol o g y, s u c h as r u b e osis iri dis, a niri dia, or iris c ol o b o m a  in  
t h e st u d y e y e. 
• C or n e al p at h ol o g y t h at is eit h er pr o gressi v e or s uffici e nt t o re d u c e B C D V A t o 
w ors e t h a n 2 0/ 2 0 i n t h e st u d y  e y e. 
• A n y c or n e al d ystr o p h y i n cl u di n g b as e m e nt m e m bra n e d ystr o p h y i n t h e st u d y  e y e.  
• K erat o c o n us or s us pe cte d of h a vi n g k erat o c o n us i n t h e st u d y e y e . 
• H as u n d er g o n e pre vi o us c or ne al or i ntra o c ular s ur ger y  in t h e st u d y e y e , e x c e pt f or 
t h e c atara ct s ur ger y a n d e y es wit h pre vi o us pter y gi u m  e x cisi o n are p er mitte d as 
l o n g as t h e pter y gi u m di d n ot e xte n d m ore t h a n 2 m m o nt o t h e c or n ea fr o m t h e 
li m bus .  
• S u bje cts wit h s eri o us c o -m or bi d c o n diti o ns t h at i n t h e j u d g m e nt  of t h e i n v esti gat or m a k es 
i n cl usi o n i n t h e st u d y n ot i n t h e b est i nterest of t h e s u bje ct. 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 2 0  
 
• S u bje cts ta ki n g s yste mic m e dic ati o n t h at m a y i n creas e s e nsiti vit y t o U V li g ht s u c h as 
tetra c y cli n e, d o x yc y cli n e, ps orale ns, a mi o d ar o n e, p h e n ot hia zi nes, c hl or o q ui ne, 
h y dr o c hl or ot hia zi d e, h y p erici n, k et o pr ofe n, pir o xica m, l o m efl o xa ci n, a n d m et h o xs ale n. 
L D D tre at m e nt i n p atie nts ta ki n g s u c h m e dic ati o ns m a y le a d t o irre v ersi ble p h ot ot o xic 
d a m a ge t o t h e e y e. T his is o nl y a p artial list of p h ot os e nsitizi n g m e dic ati o ns. Ple a s e 
e v al u ate all m e dic ati o ns t h at t h e p atie nt is ta ki n g f or t his effe ct pri or t o c o nsi d erati o n f or 
i m pla ntati o n.  
• S u bje cts ta ki n g a s yste mic m e dic ati o n t h at is c o nsi d ere d t o xic t o t h e reti n a s u c h as 
ta m o xif e n. 
• S u bje cts w h o t h e d o ct or b elie v es will b e u n a ble t o m ai ntai n ste a d y fi xati o n t h at is 
n e c ess ar y f or c e ntrati o n of t h e L D D li g ht tre at m e nt i n t h e st u d y e y e.  
• Irre g ular asti g m atis m i n t h e st u d y e y e. 
•  H ist or y of o c ular h er p es si m ple x vir us i n t h e st u d y e y e.  
•  S u bje ct w h o h as p artici p ate d wit hi n a n ot h er o p ht h al mic cli nic al trial wit hi n t h e last 3 
m o nt hs.  
•  S ut ures us e d at t h e ti m e of s ur ger y t o cl os e t h e i n cisi o n w o u n d i n t h e st u d y e y e  
•  A st u d y e y e at ti m e of s cre e ni n g n ote d wit h a n o c ular a d vers e e v e nt t h at c o ul d b e 
n e gati v el y i m p a cte d b y li g ht tre at m e nt or n e gati v el y i m p a ct t h e effe cti v e ness or s afet y of a 
li g ht tre at m e nt. T his i n cl u d es c or n e al e d e m a a n d s u p erficial p u nctate k eratitis ( S P K) 
( Gra d e 3 ( m o d erate) or m ore s e v ere)), reti n al c o n diti o ns i n cl u di n g dia b etic reti n o pat h y a n d 
c yst oi d m a c ular e d e m a, e pit h elial d efe ct, a n d e n d o p ht h al mitis.  
•  A st u d y e y e wit h a n y o n g oi n g a d v ers e e v e nt.  
•  A st u d y e y e at ti m e of s cre e ni n g n ote d wit h e vi d e nc e of pre mat ure p h ot o p ol y m eriz ati o n as 
e vi d e n c e d as a z o n e o n t h e le ns s urfa c e.  
•  A st u d y e y e at ti m e of s cre e ni n g n ote d wit h a n y e vi d e n ce of p osteri or c a ps ular o p a cit y 
( P C O). 
 
 
 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 2 1  
 
7  
S T U D Y M A T E RI A L S A N D M E T H O D S  
7. 1  
D E VI C E D E S C RI P TI O N  
R x Si g ht ’s Li g ht A dj usta ble Le ns (L A L ) is a silic o n e i ntra o c ular le ns w h ose s h a pe a n d f o c usi n g 
c h ara cteristics c a n b e m o difie d after i m pla ntati o n usi n g a n off ic e-bas e d U V li g ht s o urc e, t h e 
R x Si g ht Li g ht D eli v er y D e vic e ( L D D), t o i m pr o v e u n c orre cte d vis u al a c uit y.  
 
7. 1.1  R X S I G H T L I G H T A D J U S T A B L E IN T R A O C U L A R L E N S  
T h e R x Si g ht Li g ht A dj usta ble Le ns (L A L ) is t h e i d e ntic al d e vic e a p pr o v e d i n P 1 6 0 0 5 5 a n d 
a p pr o v e d s u p ple me nts . It will b e i m pla nte d i n a c o m m ercial e n vir o n m e nt.   
 
T h e L A L is f ol d a ble p osteri or c h a m b er, U V filteri n g, t hre e-piec e p h ot orea cti ve silic o n e le ns wit h 
bl u e P M M A ( p ol y m et h yl m et ha cr ylate) m o difie d -C h a ptics, a 6. 0 m m bic o n ve x o ptic wit h s q u are d 
p osteri or e d ge, a n d a n o v erall dia m eter  of 1 3. 0 m m. T h e L A L  o ptic d esi g n ( Fi g ure 1 ) als o f e at ures 
a U V filteri n g p osteri or s urf a c e la y er , t o f urt h er e n ha nc e t h e U V a bs or bi n g pr o p erties of t h e L A L  
le ns a n d li mit reti n al e x p os ure.  
 
 
 
F I G U R E 1:   R X S I G H T L I G H T A D J U S T A B L E L E N S (L A L )  
(A ) T O P VI E W A N D (B ) C R O S S -S E C TI O N VI E W O F T H E O P TI C S H O WI N G  
L A L  WI T H A P O S T E RI O R L A Y E R  
 
A s u m m ar y of t h e L A L  d esi g n c h ara cteristics is pres e nte d b el o w:  
Le ns O ptic  
• Material:  P h ot o -re a cti v e, U V a bs or bi n g Silic o n e 
• Li g ht tra ns missi o n:  U V c ut -off at 1 0 % T ≥ 3 9 2 n m  f or all le ns p o w er 
• I n d e x of refracti o n:  1. 4 3  
• Di o pter p o w er:   + 1 0 t o + 1 5. 0 di o pters a n d + 2 5. 0 t o + 3 0. 0 D i n 1. 0 di o pter i n cre m e nts; 
+ 1 6. 0 t o + 2 4. 0 di o pters i n 0. 5  di o pter i n cre me nts  
• O ptic t y p e:  Bic o n v e x  
• O ptic e d ge:  S q u are o n p osteri or s urf ac e a n d r o u n d o n a nteri or s urfa ce  
• O v erall dia m eter:  13. 0 m m  
• O ptic dia m eter:  6. 0 m m  
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 2 4  
 
s et, wit h o n e p air h a vi n g cle ar le ns es f or i n d o or us e a n d t h e ot h er p air wit h ti nte d le ns es f or 
o ut d o or us e. I nstr u ct t h e p atie nt t o w e ar t h e “fit o ver” U V pr ote cti v e e y e we ar o ver t h eir 
e xisti n g c orre cti v e s p e cta cles at all ti m es; k e e pi n g t h e e y es cl os e d w h e n c ha n gi n g 
s p e cta cles. 
 
 
7. 1.5  D E VI C E M A N U F A C T U R E R  
T h e L A L a n d L D D are m a n uf a ct ure d b y R x Si g ht, I n c. l o c ate d i n Alis o Viej o, Calif or nia ( F D A 
Esta blis h m e nt Re gistrati o n N o. 3 0 1 2 7 1 2 0 2 7). R x Si g ht, I n c. h as a n esta blis h e d Q u alit y 
Ma n a ge m e nt S yste m t h at is i n c o nf or m a nc e wit h t h e f oll o wi n g sta n d ar ds:  
•  2 1 C. F. R. Part 8 2 0 ( Q u alit y S yste m Re g ulati o n)  
•  E N I S O 1 3 4 8 5: 2 0 1 6 ( Q u alit y Ma n a ge m e nt S yste m wit h s c o p e: d esi g n, m a n ufa ct ure, 
distri b uti o n a n d s er vic e of t h era pe utic, s ur gic al a n d dia g n ostic d e vices a n d i nstr u m e nts 
es p e ciall y f or o p ht h al m ol o g y), a n d  t h e Me dic al D e vice Dire cti v e 9 3/ 4 2/ E E C.  
 
T h e S p o ns or will k e e p re c or ds t o d o c u me nt t h e p h ysic al l o c ati o n of all i n v esti gati o n al d e vic es 
fr o m s hi p m e nt t o t h e i n v esti gati o n al sites u ntil us e, ret ur n or dis p os al. Tra c e a bilit y f or b ot h t h e 
L A L a n d L D D will b e a c hie v e d b y us e of d e vic e s erial n u m b ers.  
 
T h e pri n ci p al i n v esti gat or or a n a ut h oriz e d d esi g n e e s h all k e e p re c or ds d o c u m e nti n g t h e re c ei pt, 
us e, ret ur n, a n d dis p os al of t h e i n v esti gati o n al d e vic es, w hic h s h all i n cl u d e:  
•  T h e d ate of re c ei pt  
•  I d e ntific ati o n of e a c h i n v esti gati o n al d e vic e ( b atc h n u m ber/s erial n u m b er or u ni q ue c o de),  
•  T h e e x pir y d ate, if a p plic a ble,  
•  T h e d ate or d ates of us e,  
•  S u bje ct i d e ntific ati o n  
•  D ate o n w hic h t h e i n v esti gati o n al d e vic e w as ret ur ne d/e x pla nte d fr o m s u bje ct, if 
a p plic a ble, a n d  
•  T h e d ate of ret ur n of u n us e d, e x pire d or m alf u ncti o ni n g i n v esti gati o n al d e vic es, if 
a p plic a ble.  
 
7. 1.6  IN DI C A TI O N S F O R U S E  ( NO C H A N G E C O M P A R E D T O P M A A P P R O V A L ) 
T h e Li g ht A dj usta ble Le ns a n d Li g ht D eli v er y D e vic e s yste m is i n dic ate d f or t h e re d u ctio n 
of resi d u al asti g m atis m t o i m pr o v e u n c orre cte d vis ual a c uit y after re m o v al of t h e 
c atara ct o us n at ural le ns b y p ha c oe m ulsific ati o n a n d i m pla ntati o n of t h e i ntra o c ular le ns i n 
t h e c a ps ular b a g, i n a d ult p atie nts: 
 
• 
Wit h pre -e xisti n g c or n e al asti g m atis m of ≥ 0. 7 5  di o pters  
• 
Wit h o ut pre -e xisti n g m a c ular dis e as e. 
 
T h e s yste m als o re d u ces t h e li k eli h o o d of cli nicall y si g nific a nt resi d ual s p heric al refra cti v e 
err ors. 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 2 9  
 
 
7. 7  
A D J U S T M E N T P R O C E D U R E (S ) 
Ref er t o t h e L D D O p erat or’s m a n u al f or i nstr u cti o ns o n L D D start u p  a n d i nstr u cti o ns f or t h e  
d ail y ali g n m e nt test t o b e p erf or m e d pri or t o t h e first tre at m e nt of t h e d a y. 
1.  Wit hi n t h e Patie nt I D a n d Patie nt D ata s cre e ns, f oll o w t h e t o u c hs cree n pr o m pts t o e nter 
re q u este d i nf or m ati o n. Wit hi n t h e Patie nt I D s cre e n, t h e s u bje ct’s m e as ure d m a nifest 
refra cti o n is e ntere d i nt o t h e m a nifest refra cti o n i n p ut fiel ds. Wit hi n t h e Patie nt D ata s cre e n,  
a refra cti o n tar get will b e e ntere d as 0. 0 0 s p h ere , 0. 0 0 c yli n d e r, a n d 0 a xis. 
2.  Wit hi n t h e C o nfir m ati o n s cre e n, re vie w all i nf or m ati o n a n d press t h e “ C o nfir m ” b utt o n . 
3.  V erif y t h at t h e L D D ri n g li g hts a n d reticle tar get are a cti v ate d.  
4.  A p pl y  t o pic al a n est h etic.   
5.  P ositi o n t h e R x S i g ht su p plie d c o nta ct le ns  (
) o n t h e c or ne a 
usi n g
 t h e c o u pli n g m e di u m.   
N ote:  T h e R x Si g ht c o nta ct le ns is si milar t o t h os e us e d i n ot h er o p ht h al mic pr o c e d ures i n 
w hic h  c ust o miz e d m a g nific ati o n is re q uire d. T o e ns ure c orre ct m a g nific ati o n f or tre at m e nt, 
us e o nl y t h e R x Si g ht d esi g n ate d c o nta ct le ns.  
6.  I nstr u ct t h e s u bje ct t o f o c us strai g ht a h e a d o n t h e L D D fi x ati o n li g ht wit h t h e e y e t o b e 
tre ate d. 
7.  Usi n g t h e micr os c o p e , f o c us o n t h e c or ne a a n d v erif y t h at t h ere are n o tra p p e d b u b bles 
pres e nt. C o nfir m ali g n m e nt of t h e c o nta ct le ns b y a p pr o xi m atel y  ali g ni n g t h e P ur ki nje i m a ges 
t o t h e i n n er circle of t h e reticle tar get. 
8.  U si n g t h e micr os c o p e, f o c us o n t h e L A L h a ptics a n d ali g n t h e reticle tar get wit h t h e p eri p h ery 
of t h e L A L. Press t h e “ Re a d y ” b utt o n. I nitiate t h e U V e x p osure as pr o m pte d b y t h e L D D 
di s pla y usi n g t h e tri g ger. Us e t h e j o ystic k t o k e e p t h e L A L c e ntere d i n t h e ali g n m e nt reticle. 
Perf or m micr o a dj ust m e nts t o k e e p t h e reticle tar get c e ntere d t o t h e L A L a n d t o k e e p t h e L A L 
i n f o c us. I n t h e c as e of s u bje ct m o ve m e nt, l oss of ali g n m e nt, or l oss of f oc us, p a use t h e 
tre at m e nt, q uic kl y ref oc us, re ali g n t h e le ns wit h res p e ct t o t h e reticle b e a m, a n d i m m e diatel y 
res u m e tre at m e nt t o li mit t h e d urati o n of a n y p a us es o n c e t h e li g ht tre at m e nt h as b e e n 
i nitiate d. 
N ote: Al w a ys m ai ntai n t h e L A L i n f o c us b y f o c usi n g at t h e h a ptics. N e v er f oc us o nt o t h e 
C C C (c a ps ul ot o m y) or P ur ki nje i m a ges.  
9.  I n t h e c as e  of a n a b orte d A dj ust me nt Tre at m e nt, d o n ot i nitiate a n e w tre at m e nt s e q u e n c e; 
i nste a d; c o nta ct t h e S p o ns or f or f urt h er i nstr ucti o ns.  
1 0.  F oll o wi n g t h e li g ht a dj ust m e nt, t h e s u bje ct will c o nti n u e t o w e ar t h eir U V pr ote cti v e e y e w e ar 
as i nstr u cte d . 
 
7. 8  
L O C K -IN P R O C E D U R E (S ) 
Ref er t o t h e L D D O p erat or’s m a n u al f or i nstr u cti o ns o n L D D start u p  a n d i nstr u cti o ns f or t h e 
d ail y ali g n m e nt test t o b e p erf or m e d pri or t o t h e first tre at m e nt of t h e d a y.  

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 3 1  
 
1 5.  T h e s u bje ct will b e p er mitte d t o dis c o nti n u e w e ar of t h e U V pr ote cti v e e y e w e ar e x a ctl y 2 4 
h o urs  after t h e s u bje ct’s fi n al l o c k-i n tre at m e nt f or eit h er e y e (as a p pr o priate) h as b e e n 
c o m plete d . 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 3 4  
 
 
7. 1 1  
D A T A R E P O R TI N G  
Ele ctr o nic d ata c a pt ure ( E D C) will  b e utiliz e d f or t his st u d y.  Cas e re p ort f or ms ( C R Fs)  will 
b e d e v el o p e d b y t h e s p o ns or.  I n or d er t o f a cil itate d ata e ntr y, t h e C R Fs c oi n ci d e wit h t h e 
d ata e ntr y p a ges i n t h e E D C s y ste m. Res e arc h sites will b e pr o vi d e d wi t h s o urc e d o c u m e nt 
te m plates ( S D Ts) t h at c orrelate wit h t h e C R Fs. T h e a p pr o priate S D T s will b e c o m plete d a n d 
i nitiale d or si g n e d w h ere i n dic ate d at e a c h e x a mi n ati o n.  All S D T s will b e c o m plete d i n a 
le gi ble m a n n er i n bla c k/ bl u e i n k.  
 
A n y c orre cti o ns t o t h e S D T s will b e m a d e b y dra wi n g a si n gle li n e t hr o u g h t h e i n c orre ct 
e ntr y, re c or di n g t h e c orre ct i nf or m ati o n, a n d i nitiali n g a n d d ati n g t h e c h a n ge.  T h e st u d y 
S D T s a n d d ata e ntere d i n t h e E D C s yste m will b e re vie w e d b y t h e St u d y M o nit or.  
All cli nic al d ata ge n erate d i n t h e st u d y will b e s u b mitte d t o t h e R x Si g ht Cli nic al Aff airs 
D e p art m e nt or d esi g n ate d C R O f or q u alit y ass ura n c e re vie w a n d stati stic al a n al ysis.  All 
S D T s a n d d ata e ntere d i nt o t h e E D C s yste m will b e re vie w e d f or c o m plete n ess a n d e vi d e nt 
re c or di n g err ors will b e re ctifie d b y c o nta ct wit h t h e a p pr o priate cli nic al site.  C o m p uteriz e d 
d ata c h e c ks will b e us e d t o i d e ntif y u n us ual d ata e ntries f or v erific ati o n pri or t o statistic al 
a n al ysis.  
 
T o mi ni miz e t h e a m o u nt of missi n g d ata, i n v esti gat ors will b e trai n e d o n t h e d eleteri o us 
eff e ct t h at missi n g d ata h a v e o n trial i nte grit y a n d cre di bilit y a n d t h at missi n g d ata c o ul d 
di mi nis h t h e s cie ntific v al u e of all s u bje cts' altr uistic c o ntri b uti o ns.  
 
7. 1 2  
S T U D Y C O M P L E TI O N P R O C E D U R E S  
A n E n d of St u d y F or m m ust b e c o m plete d f or all s u bje cts e nr olle d i n t h e st u d y u p o n s u bject 
c o m pleti o n, wit h dra w al or dis c o nti n u ati o n.  
 
7. 1 2. 1  S U B J E C T C O M P L E TI O N  
S u bje cts are c o nsi d ere d t o h a ve c o m plete d t h e s t u d y if t h e st u d y e y e h a s c o m plete d t h e 
P ost o p M o nt h 3 e x a mi n ati o n.   
 
S u bje cts wit h o c ular s eri o us a d v ers e e v e nts or a d v erse d e vice effe cts t h at are u nres ol ve d at 
st u d y e xit s h o ul d c o nti n ue t o b e f oll o w e d u ntil res ol uti o n of t h e e v e nt or u ntil t h e y are sta ble 
p er t h e i n v esti gat or’s e v al u ati o n . 
  
7. 1 2. 2  S U B J E C T D I S C O N TI N U A TI O N A F T E R L I G H T T R E A T M E N T S  
T h e s u bje ct will o nl y b e wit h dra w n fr o m t h e st u d y if t h e L A L is e x pla nte d  i n t h e st u d y e ye 
after A dj ust m e nt # 1  or t h e s u bje ct h as d e c eas e d . 
  
T h e re as o n f or dis c o nti n u ati o n will b e re c or d e d o n t h e a p pr o priate st u d y w or ksh e et.  S u bje cts 
w h o are dis c o nti n u e d fr o m t h e st u d y will still b e a p art of t h e st u d y a n al ys es u p u ntil t h e 
p oi nt t h e y are e xite d.  I n t h e c as e of a n e x pla nt, t h e i n v esti gat or s h o ul d c o nti n ue f oll o w -u p 
f or a p eri o d t h at e ns ures n o a d vers e c o nse q ue nc es h a v e res ulte d.  W h e n p ossi ble, all 
n e c ess ar y cli nic al ass ess me nts will b e p erf or me d pri or t o t h e S u bje ct e xiti n g t h e st u d y e ve n if 
t h e ass ess m e nt w as n ot s c h e d ule d at t h at p artic ular visit. 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 3 5  
 
 
 
7. 1 2. 3  L O S T T O F O L L O W - UP  
S u bje cts f or w hic h t h e fi n al p ost -o p erati v e c as e re p ort f or m is o v er d u e a n d w h o ref us e t o b e 
f oll o w e d, or h a v e diffic ult y b ei n g f oll o w e d, or c a n n ot b e c o nta cte d d es pite e xte nsi v e writte n 
a n d tele p h o n e f oll o w -u ps t o d eter mi n e t h e fi n al cli nic al o utc o m e , will b e c o nsi d ere d l ost t o 
f oll o w-u p. Sites m ust m a k e a mi ni m u m of t hre e  d o c u m e nte d atte m pts via tele p h o n e, e m ail, 
or re g ular m ail t o c o nta ct t h e s u bje ct.  If t h e s u bje ct d o es n ot re pl y t o a n y of t h es e atte m pts, 
t h e site m ust s e n d a letter b y c ertifie d m ail ( wit h a re q u est f or n otific ati o n of re c ei pt of 
d eli v er y) t o t h e s u bje c t.  If a s u bje ct is n o n-res p o nsi ve t o t h es e f oll o w-u p atte m pts, t h e 
s u bje ct will b e c o nsi d ere d t o b e l ost t o f oll o w-u p . 
 
7. 1 2. 4  S T U D Y T E R MI N A TI O N  
T h e st u d y m a y b e st o p p e d at a n y ti m e b y t h e S p o ns or  f or re as o n a ble c a us e wit h a p pr o priate 
n otific ati o n. C o n diti o ns t h at m a y w arra nt st u d y ter mi n ati o n i n cl u de, b ut are n ot li mite d t o t h e 
f oll o wi n g: 
•  Saf et y c o n c er ns. Cli nic al d ata fr o m t h e st u d y will b e m o nit ore d t o ass ure t h e s af et y of 
e nr olle d s u bje cts.  
 
If t h e cli nic al st u d y is pre m at urel y ter mi n ate d, t h e S p o ns or will i nf or m t h e I n v esti gat or, t h e 
I R B, a n d ot h er a p pr o priate re g ulat or y b o dies. If t h e S p o ns or ter mi nates t h e st u d y f or s af et y 
re as o ns, it will i m m e diatel y n otif y t h e I n v esti gat or, t h e I R B, a n d ot her a p pr o priate re g ulat or y 
b o dies a n d pr o vi de a n e x pla n ati o n of t h e re as o ns f or ter mi n ati o n. T h e I n v esti gat or will b e 
pr o vi d e d wit h i nstr u cti o ns f or st u d y ter mi n ati o n a n d a p plic a ble s u bje ct f oll o w -u p. T h e 
S p o ns or will c o nti n u e t o pr o vi d e res o urc es t o f ulfil l t h e Cli nic al St u d y Pla n o bli gati o ns f or 
f oll o w-u p of t h e s u bje cts e nr olle d i n t h e st u d y.  
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 3 9  
 
 
 
8. 5.2.1  M a nifest C yli n de r  ( M R C Y L) 
T h e M R C Y L will b e s u m m ariz e d b e gi n ni n g at A dj ust m e nt # 1  usi n g d es cri pti ve statistics f or 
c o nti n u o us o utc o m es  stratifie d b y t h e L A L  tre at m e nt gr o u p, t h e L A L hist oric al co ntr ol 
gr o u p , a n d t h e M o n of oc al I O L hist oric al c o ntr ol gr o u p.  T h e n u m b er a n d p erce nt of e y es 
wit h a M R C Y L of ≤0. 2 5 D, 0. 5 0, 0. 7 5 D, 1. 0 D, a n d > 1 . 0 D at e a c h visit o bs er v e d b y eit h er 
t h e L A L tre at m e nt gr o u p ,  t h e L A L hist oric al c o ntr ol gr o u p , or t h e M o n of o cal I O L hist oric al 
c o ntr ol gr o u p  will b e re p orte d .   
8. 5.2.2  V e ct o r Diffe r e nc e  
Err or v e ct or ( E V)  f or t h e L A L tre at m e nt gr o u p  will b e pres e nte d as t h e v e ct or differe n c e 
b et w e e n i nte n d e d refracti v e c orre cti o n (I R C) v e ct or at A dj ust m e nt # 1 a n d s ur gic all y i n d u c e d 
refra cti v e c orre cti o n ( SI R C) v e ct or at P ost o p M o nt h 3. 
 
Err or v e ct or ( E V) f or t h e L A L hist oric al c o ntr ol gr o u p  will b e pres e nte d as t h e  v e ct or 
diff ere nc e b et w ee n i nte n d e d refra cti ve c orre cti o n (I R C) v e ct or  at A dj ust m e nt # 1 a n d 
s ur gic all y i n d u c e d refracti v e c orre cti o n ( SI R C) v e ct or at P ost o p M o nt h 6 . F or e y es i n t h e 
L A L hist oric al c o ntr ol gr o u p, t h e I R C will b e t h e m a nif est refra cti v e c yli n der ( 0. 5 D a n d 
M Ra xis). 
 
Err or v e ct or ( E V) f or t h e M o n of o c al I O L hist oric al c o ntr ol gr o u p will b e pres e nte d as t h e  
v e ct or diff ere n ce b et w e e n i nte n d e d refracti v e c orre cti o n (I R C) v e ct or at 1 7 -2 1 d a ys p ost o p 
a n d s ur gic all y i n d u c e d refra cti v e c orre cti o n ( SI R C) v e ct or at P ost o p M o nt h 6. F or e y es i n t h e 
M o n of o c al I O L hist oric al c o ntr ol gr o u p, t h e I R C will b e t h e m a nif est refracti v e c yli n d er ( 0. 5 
D a n d M Ra xis).  
 
T h e m e a n m a g nit u d e of E V will b e c o m p are d b et w e e n t h e L A L tre at m e nt gr o u p, t h e L A L 
hist oric al c o ntr ol gr o u p, a n d t h e M o n of oc al I O L hist oric al c o ntr ol gr o u p .   
 
T h e E V will b e c alc ulate d f or e a c h e y e b ase d o n E y d el m a n 3 as f oll o ws: 
I R C = F or all s u bje cts, t h e m a g nit u d e of t h e I R C is 0. 5 D. T h e I R C a xis is t h e m a nif est 
refra cti v e c yli n d er a xis as m e as ure d at t h e A dj ust m e nt # 1/ 1 7 -2 1 d a y visit.  
SI R C = t h e v e ct or diff ere nc e b et w e e n asti g m atic c orre cti o n v e ct or at A dj ust m e nt # 1 a n d 3 
M o nt hs ( L A L tre at m e nt gr o u p ) or 1 7 -2 1 d a y/ A dj ust m e nt # 1 visit a n d P ost o p M o nt h 6  ( L A L 
hist oric al c o ntr ol gr o u p  a n d M o n of oc al I O L hist oric al c o ntr ol gr o u p ) 
E V = t h e v e ct or diff ere n ce b et w e e n I R C at A dj ust m e nt # 1 a n d SI R C at 3 M o nt hs  ( L A L 
tre at m e nt gr o u p) or 1 7-2 1 d a y / A dj ust m e nt # 1 visit a n d P ost o p M o nt h 6 ( L A L hist oric al 
c o ntr ol gr o u p  a n d M o n of o cal I O L hist oric al c o ntr ol gr o u p) (I R C – SI R C). 
T h e m e a n a n d sta n d ar d d e viati o n of t h e m a g nit u d e of E V will b e c alc ulate d al o n g wit h t h e 
9 5 % c o nfi d e n ce i nter v al of t h e m e a n f or  t h e L A L tre at m e nt gr o u p at P ost o p M o nt h 3  a n d f or 
t h e L A L hist oric al c o ntr ol gr o u p  a n d M o n of oc al I O L hist oric al c o ntr ol gr o u p  at P ost o p 
 
3 M al vi n a B. E y d el ma n, et al. " St a n dar diz e d A n al yses of C orre cti o n of Asti g matis m b y La ser S yst e ms T h at 
R es h a pe t h e C or n ea", J o ur nal of R efra cti ve S ur ger y V ol u me 2 2 Ja n uar y/ Fe br uar y 2 0 0 6, p p 8 1 -9 5  

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 4 0  
 
 
M o nt h 6 , s e p aratel y.  T h e o utc o m es will b e n u m eric all y c o m p are d a n d cli nic all y ass ess e d.  
N o f or m al statistic al c o m p ari s o n will b e p erf or me d. 
 
8. 5.2.3  M R S E  
T h e m e as ure d M R S E , a dj uste d M R SE (t o a c c o u nt f or t h e m e as ure d dista nc e of 4 m eters)  a n d 
c h a n ge i n M R S E fr o m A dj ust m e nt # 1  will b e s u m m ariz e d b y t h e d es cri pti v e statistics f or 
c o nti n u o us o utc o m es (s u c h as m e a n a n d sta n d ar d d e via ti o n) a n d t h e 9 5 % c o nfi d e nc e i nter val 
of t h e m e a n at e a c h visit o bs er v e d b y s u bje cts wit hi n t h e L A L tre at m e nt gr o u p , t h e L A L 
hist oric al c o ntr ol gr o u p, a n d t h e M o n of oc al I O L hist oric al c o ntr ol gr o u p  res p ecti v el y. 
 
8. 5.2.4  A c c ur a c y of M R S E  
T h e n u m b er a n d p erc e nt of e y es wit h a M R S E c orre cti o n c o m p are d t o t h e i nte n de d tar get 
wit hi n 0. 2 5 D, 0. 5 0 D, 0. 7 5 D, 1. 0 D, 1. 2 5 D, 1. 5 D, 1. 7 5 D, a n d ≥2. 0 D  will b e re p orte d f or 
t h e L A L tre at m e nt gr o u p at P ost o p M o nt h 3  a n d f or t h e L A L hist oric al c o ntr ol gr o u p  a n d 
M o n of o c al I O L hist oric al c o ntr ol gr o u p  at P ost o p M o nt h 6 . A d diti o nall y, t h e d e viati o n of t h e 
a c hie v e d a dj ust m e nt fr o m t h e atte m pte d a dj ust m e nt will b e s u m m ariz e d b y t h e d es cri pti v e 
statistics f or c o nti n u o us o utc o mes b y L A L tre at m e nt gr o u p, L A L hist oric al c o ntr o l gr o u p, 
a n d M o n of o cal I O L hist oric al c o ntr ol gr o u p .  
 
T h e 9 5 % c o nfi d e n ce i nter v al of t h e m e a n d e viati o n a n d t h e 9 5 % c o nfi d e n ce i nter v al of t h e 
pr o p orti o n of e yes wit hi n 0. 5 0 D a n d 1. 0 0 D will b e pr o vi d e d.  
 
8. 5.2.5  A bs ol ute M R S E  
T h e a n al ys es m et h o ds d es cri b e d f or t h e M R S E will b e us e d f or a n al y zi n g t h e a bs ol ute 
M R S E.  
 
8. 5.2.6  D ef o c us E q ui v ale nt ( D E Q)  
T h e D E Q , as d efi n e d as t h e a bs ol ute v al ue of t h e M R S E err or t o tar get pl us h alf t h e a bs ol ute 
v al u e of t h e M R C Y L,  will b e s u m m ariz e d d es cri pti v el y a t t h e A dj ust m e nt # 1  visit  a n d  
P ost o p M o nt h 3  f or t h e L A L tre at m e nt gr o u p a n d at t h e A dj ust m e nt # 1/1 7 -2 1 d a y  visit  a n d 
P ost o p M o nt h 6 visit f or t h e L A L hist oric al c o ntr ol gr o u p  a n d M o n of o cal I O L hist oric al 
c o ntr ol gr o u p .  T h e n u m b er a n d p erce nt of e y es wit h D E Q ≤0. 5 D  a n d  1. 0 D will als o b e 
s u m m ariz e d at t h e c orres p o n di n g visit.  
 
8. 5.2.7  A ut o r efr a cti o n  
A ut orefra cti o n s p h ere, c yli n der, a n d s p h eric al e q ui v ale nt will b e s u m m ariz e d d es cri pti v el y at 
e a c h visit o bs er v e d b y s u bje cts wit hi n t h e L A L tre at m e nt gr o u p , t h e L A L hist oric al c o ntr ol 
gr o u p , a n d t h e M o n of oc al I O L hist oric al c o ntr ol gr o u ps res p ecti v el y. 
 
8. 5.2.8  M o n o c ul a r U nc o r r e cte d Vis u al A c uit y  
M o n o c ular U C D V A will b e pres e nte d wit h t h e n u m b er a n d p erc e nt of e y es  t h at f all i nt o e a c h 
c ate g or y of U C D V A  at e a c h visit o bs er v e d b y s u bjects wit hi n t h e L A L tre at m e nt gr o u p , t h e 
L A L hist oric al c o ntr ol gr o u p , a n d t h e M o n of oc al I O L hist oric al c o ntr ol gr o u ps res pe cti v el y 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 4 1  
 
 
(e. g. 2 0/ 2 0 or b etter, 2 0/ 2 5 or b etter, 2 0/ 3 2 or b etter, etc.).  T h e l o g M A R U C D V A will b e 
s u m m ariz e d b y d es cri pti v e statistics f or c o nti n u o us o utc o m es f or e a c h visit.  C h a n ge i n 
U C D V A fr o m t h e 1 7 -2 1 d a y/ A dj ust m e nt # 1  visit will b e pres e nte d at e a c h visit  as c ate g orical 
o utc o m es of “i n cre as e of  1 5 letters or m ore ”, “I n cre as e of  1 0 -1 4 letters ”, “I n creas e of  5-9 
letters ”, “ N o c h a n ge ”, “ D e cre as e of 5 -9 letters ”, “ D ecre as e of  1 0 -1 4 letters ”, a n d “ D e creas e 
of  1 5 letters or m ore ”.   T h e c h a n ge i n l o g M A R U C D V A fr o m t h e 1 7 -2 1 d a y/ A dj ust me nt # 1  
visit will als o b e pres e nte d . 
 
8. 6  
S A F E T Y P A R A M E T E R S   
T h e f oll o wi n g s af et y o utc o m es will b e s u m m ariz e d d es cri pti v el y b as e d o n t h e o bs er v e d d ata  
of t h e Saf et y p o p ulati o n . T h e  9 5 % c o nfi d e n c e i nter v als f or m e a ns or p erc e nta ge m a y b e 
pres e nte d, as a p pr o priate.  
 
8. 6.1  A D V E R S E E V E N T S ( A E) 
F or e a c h a d v ers e e v e nt, t h e n u m b er of re p orts, n u m b er a n d p erce nt of s u bje cts wit h t h e A E, 
a n d n u m b er a n d p erce nt of e y es wit h t h e A E will b e s u m m ariz e d  at e a c h p ost o perati v e visit.  
Seri o us o c ular A E s a n d t h e n o n -o c ular s eri o us will b e s u m m ariz e d i n t h e s a m e m a n ner .  
A d diti o n all y, f or e a c h  d e vic e -relate d A E re p orte d d uri n g t h e st u d y will b e pres e nte d i n t h e 
s a m e m a n n er. 
 
8. 6.2  M A NI F E S T C Y LI N D E R ( M R C Y L) 
F or all e y es i n t h e Saf et y p o p ulati o n, M R C Y L will b e s u m m ariz e d  at t h e fi n al s c h e d ule d visit 
usi n g d es cri pti v e statistics f or c o nti n u o us o utc o m es  stratifie d b y t h e L A L tre at m e nt gr o u p, 
t h e L A L hist oric al c o ntr ol gr o u p, a n d t h e M o n of oc al I O L hist oric al c o ntr ol gr o u p.  T h e 
n u m b er a n d p erc e nt of e y es wit h a M R C Y L of  ≥1. 0 0 D a n d ≥2. 0 0  D o bs er v e d b y eit h er t h e 
L A L tre at m e nt gr o u p,  t h e L A L hist oric al c o ntr ol gr o u p, or t h e M o n of oc al I O L hist oric al 
c o ntr ol gr o u p will b e re p orte d .   
 
8. 6.3  B C D V A  
F or all e y es i n t h e Saf et y p o p ulati o n, t h e p erc e nta ge of e y es t h at f all i nt o e a c h c ate g or y of 
B C D V A at e a c h visit (e. g. 2 0/ 2 0 or b etter, 2 0/ 2 5 or b etter, 2 0/ 3 2 or b etter, etc.) will b e 
pres e nte d. I n a d diti o n, t h e ch a n ge i n m o n o c ular B C D V A fr o m t h e A dj ust me nt # 1  visit will 
b e pres e nte d at e a c h v isit as c ate g oric al o utc o mes of “I n creas e of  15 letters or m ore ”, 
“I n cre as e of 1 0 -1 4 letters ”, “ I n cre as e of  5-9 letters ”, “ N o c h a n ge ”, “ D e cre ase of 5 -9 letters ”, 
“ D e cre as e of  1 0 -1 4 letters ”, a n d “ D e cre as e of  1 5 letters or m ore ”  f or all e y es i n t h e Saf et y 
P o p ulati o n.   T h e m e a n c h a n ge fr o m t h e pri or visit t o t h e n e xt visit will als o b e s u m m ariz e d in 
t h e s a m e m a n n er.  
 
T h e listi n g of B C D V A a n d t h e p ossi ble re as o n f or B C D V A l oss of 1 0 letters or m ore will b e 
pr o vi d e d f or t h e e y es re p orte d wit h a 1 0-letter or m ore l oss i n B C D V A  fr o m ( 1) pre-li g ht 
tre at m e nt visit ( St u d y Visit # 1/ A dj ust m e nt # 1) t o t h e fi nal st u d y visit ( P ost o p M o nt h 3) a n d 
( 2) pre-li g ht tre at m e nt visit ( St u d y Visit # 1/ A dj ust m e nt # 1) t o a n y s u bse q ue nt visit. 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 4 3  
 
 
9  
A D V E R S E E V E N T S 
If an a d v ers e e v e nt ( A E) o c c urs, t h e first c o nc er n will b e t h e s af et y a n d w elf are of t h e 
s u bje ct; tre at m e nt s h o ul d b e pr o vi d e d as a p pr o priate f or t h e e v e nt. D uri n g t h e st u d y, t h e 
I n v esti gat or s h o ul d a p pr o priatel y tre at a n d f oll o w e a c h A E u ntil it res ol v es, sta biliz es, or it is 
d eter mi n e d t h at f urt h er i m pr o ve m e nt is n ot e x p e cte d.  
 
9. 1  
A D V E R S E E V E N T D E FI NI TI O N S   
  
 
A n a d v ers e e v e nt ( A E) is a n y u nt o w ar d m e dic al o c c urre n c e, u ni nte n de d dis e as e or  i nj ur y, or 
u nt o w ar d cli nic al si g ns (i n cl u di n g a b n or m al la b orat or y fi n di n gs) i n s u bje cts, us ers, or ot h er 
p ers o ns, w h et h er or n ot relate d t o t h e i n v esti gati o n al m e dic al d e vice.  
 
N ote 1 t o e ntr y: T his d efi niti o n i n cl u des e v e nts relate d t o t h e i n v esti gati o n al m e dical d e vice 
or t h e c o m p arat or.  
N ote 2 t o e ntr y: T his d efi niti o n i n cl u des e v e nts relate d t o t h e pr o c e d ures i n v ol v e d.  
N ote 3 t o e ntr y: F or us ers or ot h er p ers o ns, t his d efi niti o n is restricte d t o e v e nts relate d t o 
i n v esti gati o n al m e dic al de vic es.  
 
U n a ntici p ate d A d v ers e D e vice Effe cts ( U A D E) are a n y s eri o us a d v ers e effe ct o n h e alt h or 
s af et y or a n y lif e-t hre ate ni n g pr o ble m or d e at h c a us e d b y, or ass o ciate d wit h a d e vic e, if t h at 
eff e ct, pr o ble m, or d e at h w as n ot pre vi o usl y i d e ntifie d i n n at ure, s e verit y or d e gre e of 
i n ci d e n c e i n t h e i n v esti gati o n al pla n or a p plic ati o n (i n cl u di n g a s u p ple m e ntar y pla n or 
a p plic ati o n), or a n y ot h er u na ntici pate d s eri o us pr o ble m ass o ciate d wit h a d e vic e t h at relates 
t o t h e ri g hts, s af et y, or w elf are of s u bjects. 
 
A n i n v esti gat or will s u b mit t o t h e S p o ns or a n d t o t h e re vie wi n g I R B a re p ort of a n y U A D E 
o c c urri n g d uri n g a n i n v esti gati o n as s o o n as p ossi ble, b ut i n n o e v e nt later t h a n 1 0 w or ki n g 
d a ys after t h e i n v esti gat or first le ar ns of t h e effect. T h e S p o ns or will i m m e diatel y c o n d uct a n 
e v al u ati o n of a n y u n a ntici p ate d a d vers e d e vice effect. T h e res ults of t h e e v al uati o n will b e 
re p orte d t o F D A a n d t o all re vie wi n g I R B’s a n d p artici p ati n g i n v esti gat ors wit hi n 1 0 w or kin g 
d a ys of t h e S p o ns or b e c o mi n g a w are of t h e e v e nt. T h ere after t h e S p o ns or s h all s u b mit 
a d diti o n al re p o rts c o n cer ni n g t h e effe ct as F D A re q u ests. If a U A D E is d eter mi n e d b y t h e 
S p o ns or t o pres e nt a n u nre aso na ble ris k t o st u d y s u bje cts, all i n v esti gati o ns or p arts of t h e 
i n v esti gati o n pres e nti n g t h at ris k will b e ter mi n ate d as s o o n as p ossi ble. Ter mi n ati o n will 
o c c ur n ot later t h a n 5 w or ki n g d a ys after t his d eter mi n ati o n is m a d e, a n d n ot later t h a n 1 5 
w or ki n g d a ys after first re c ei vi n g n otic e of t h e e v e nt. T h e i n v esti gati o n will n ot b e res u m e d 
wit h o ut I R B a n d F D A a p pr o v al.  
 
All e v e nts t h at t h e i n v esti gat or r e gar ds as cli nic all y si g nific a nt s h o ul d b e re p orte d t o e ns ure 
f ull re p orti n g of all si g nific a nt a d v ers e e v e nts. T h e list b el o w pr o vi des a d diti o n al g ui d a nce o n 
s p e cific e v e nts t h at will n e e d t o b e re p orte d as A Es as s p e cifie d. 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 4 6  
 
 
9. 2  
A D V E R S E D E VI C E E F F E C T (A D E ) D E FI NI TI O N  
A d v ers e e v e nt relate d t o t h e us e of a n i n v esti gati o nal m e dic al d e vic e.  
 
N ote 1: T his d efi niti o n i n cl u des a d vers e e v e nts res ulti n g fr o m i ns ufficie nt or i n a d e q uate 
i nstr u cti o ns f or us e, d e pl o y m e nt, i m pla ntati o n, i nstallati o n, or o p erati o n, or a n y m alf u n cti o n 
of t h e i n v esti gati o n al m e dic al d e vic e.  
 
N ote 2: T his d efi niti o n i n cl u des a n y e v e nt res ulti n g fr o m us e err or or fr o m i nte nti o nal mis use 
of t h e i n v esti gati o n al m e dic al d e vic e.  
 
9. 3  
D E VI C E D E FI CI E N C Y (D D ) D E FI NI TI O N  
I n a d e q u a c y of a m e dic al d e vic e wit h res p e ct t o its i d e ntit y, q u alit y, d ura bilit y, relia bilit y, 
s af et y or p erf or m a nc e. N ote: D e vic e d eficie n cies i n cl u de m alf u ncti o ns, us e err ors, a n d 
i n a d e q u ate la b eli n g. 
 
9. 4  
S E RI O U S A D V E R S E E V E N T D E FI NI TI O N  
Seri o us A d v ers e E v e nts  ( S A Es) are A Es t h at le a d t o:  
•  d e at h  
•  a s eri o us d eteri orati o n i n t h e h e alt h of t h e s u bje ct t h at:  
- res ults i n a lif e-t hre ate ni n g ill n ess or i nj ur y  
- res ults i n a p er m a n e nt i m p air m e nt of a b o d y str u ct ure or f u n cti o n (e. g., bli n d n ess)  
- re q uires i n-s u bje ct h os pitaliz ati o n or pr ol o n gati o n of e xisti n g h os pitaliz ati o n  
- res ults i n m e dic al or s ur gic al i nter v e nti o n t o pre v e nt p er m a ne nt i m p air m e nt t o a 
b o d y str u ct ure or a b o d y f u ncti o n  
•  f etal distress, f etal d e at h, or a c o n ge nital a bn or m alit y or birt h d efe ct  
•  a p ote ntiall y si g ht-t hre ate ni n g c o n diti o n 
•  or is a n ot h er i m p orta nt m e dical e v e nt.   
 
9. 5  
U N A N TI CI P A T E D P R O B L E M D E FI NI TI O N  
A n u n a ntici p ate d pr o ble m is d efi n e d as a n y i n ci de nt, e x p erie n c e, or o utc o m e t h at m e ets all of 
t h e f oll o wi n g criteria: 
•  U n e x p e cte d/ u n a ntici p ate d – (i n ter ms of n at ure, s e verit y, or fre q ue nc y) gi v e n (a) t h e 
res e arc h pr o c e d ures t h at are d es cri b e d i n t h e pr ot o c ol-relate d d o c u m e nts ( pr ot oc ol, 
I C D, pr o d u ct la b eli n g, I B); a n d ( b) t h e c h ara cteristics of t h e s u bje ct p o p ulati on b ei n g 
st u die d; a n d 
•  Relate d or p ossi bl y relate d t o t h e p artici p ati o n i n t h e res e arc h ( p ossi bl y relate d m e a ns 
t h ere is a re as o n a ble p ossi bilit y t h at t h e i n ci d e nt, e x p erie n ce, or o utc o m e m a y h a ve 
b e e n c a us e d b y t h e dr u gs, d e vic es, or pr o c e d ures i n v ol v e d i n t h e res e arc h); a n d 
•  S u g gests t h at t h e res e arc h pla c es p artici p a nts or ot h ers at a gre ater ris k of h ar m [ n e w 
or i n cre as e d ris k (i n cl u di n g p h ysical, ps y c h ol o gic al, e c o n o mic, or s o cial)] t h a n w as 
pre vi o usl y k n o wn or re c o g niz e d.  
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 4 7  
 
 
9. 6  
ID E N TI FI C A TI O N A N D C O L L E C TI O N  
I d e ntific ati o n a n d c olle cti o n of a n A E b e gi ns after i nf or m e d c o ns e nt h as b e e n o btai ne d a n d 
d o c u m e nte d. Sta n d ar d s o urces of i d e ntif yi n g A Es i n cl u d e:  
•  dire ct o bs er v ati o n b y t h e I n vesti gat or or st u d y te a m m e m b er  
•  as ki n g t h e st u d y p artici p a nt a s p e cific q u esti o n (e. g., “ Si n c e y o ur last visit, h a v e y o u 
e x p erie n c e d a n y pr o ble ms wit h y o ur e y es or visi o n ? ”)  
•  u ns olicite d v ol u nte eri n g of i nf or mati o n b y t h e st u d y p artici p a nt (e. g., “ D o ct or, I h a v e 
h a d n u m er o us h ea d ac hes si n c e I starte d usi n g t his le ns. ”)  
 
O c ular A Es , o c ular S A Es , a n d s yste mic S A Es o bs er v e d or elicite d b y t h e I n v esti gat or, 
re p orte d b y t h e s u bje ct, or res ulti n g fr o m a test res ult, etc., o c c urri n g d uri n g t h e cli nic al 
i n v esti gati o n m ust b e d o c u m e nte d. D uri n g t h e st u d y, t h e I n vesti gat or s h o ul d tre at t h e st u d y 
s u bje ct as a p pr o priate t o e ns ure his/ h er s afet y a n d w elfare. Ref er t o Se cti o n 7. 1 2 . 1 f or 
a d diti o n al i nf or m ati o n p ertai ni n g t o o n g oi n g A Es at s u bje ct e xit.  
 
Pre -e xisti n g c o n diti o ns will n ot b e c o nsi d ere d A E/ S A Es b ut will b e  c olle cte d at t h e 
Scre e ni n g/ A dj ust m e nt # 1  Visit as m e dic al hist or y. A w ors e ni n g of a pre -e xisti n g c o n diti o n 
d uri n g t h e st u d y s h o ul d b e d o c u m e nte d as a n A E a n d e v al u ate d a c c or di n gl y.  
 
H os pitaliz ati o n is a criteri o n f or ass ess m e nt of s eri o us ness. H os pitaliz ati o n i n t h e a bs e n c e of 
a m e dic al A E is n ot i n its elf a n A E. F or e x a m ple, t h e f oll o wi n g re p orts of h os pitaliz ati o n 
wit h o ut a m e dic al A E s h o ul d n ot b e c o nsi d ere d eit h er a n S A E or a n A E:  
•  Pla n n e d h os pitaliz ati o n f or a pre -e xisti n g c o n diti o n wit h o ut s eri o us d eteri orati o n i n 
h e alt h (e. g., pla n n e d k n ee re pla ce m e nt s ur ger y )  
•  S o cial a d missi o n (e. g., s u bje ct h as n o pla c e t o sle e p)  
•  A d mi nistrati v e a d missi o n (e. g., f or y e arl y p h ysic al e x a m or ele cti v e pr o ce d ures n ot 
relate d t o t h e st u d y)  
•  O pti o n al a d missi o n n ot ass o ci ate d wit h a pre ci pitati o n m e dic al A E (e. g., f or ele cti v e 
c os m etic s ur ger y)  
 
9. 6.1  E V A L U A TI O N S  
W h e n e v al u ati n g A Es,  t h e Pri n ci p al  I n v esti gat or  or d ele gate d M D s u b -I n v esti gat or m ust 
d e ter mi n e if t h e e v e nt is s eri o us, ass ess t h e s e v erit y of s y m pt o ms, t h e relati o nshi p of t h e e ve nt 
t o t h e d e vic e or st u d y pr ot o c ol, usi n g t h e f oll o wi n g g ui d eli n es:  
1.  Se v e rit y  
Mil d :  s u bje ct a w are n ess of a si g n or s y m pt o m t h at is e asil y t olerate d, re q uires n o 
tre at m e nt, a n d d o es n ot i nterfere wit h s u bject’s d ail y a cti vities  
M o de r ate : s u bje ct a w are n ess of a si g n or s y m pt o m w hic h m a y b e a l o w le v el of 
c o n c er n t o t h e s u bje ct a n d m a y i nterfere wit h d ail y a cti vities, b ut c a n b e relie v e d b y 
si m ple t h era p e utic c are  

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 4 9  
 
 
res ulti n g fr o m D Ds will b e d o c u m e nte d, ass ess e d, a n d re p orte d i n a c c or da nc e wit h a d vers e 
e v e nt g ui d eli n es. D Ds t h at di d n ot le a d t o a n a d v ers e e ve nt b ut c o ul d h a ve le d t o a Seri o us 
A d v ers e D e vic e Effe ct ( S A D E) will b e re p orte d i n t h e f ut ure P M A as re q uire d i n I S O 1 4 1 5 5. 
 
9. 1 0  
U N A N TI CI P A T E D P R O B L E M ( U P) R E P O R TI N G  
If a n i n ci d e nt, e x p erie nc e, or o utc o m e m e ets all 3 criteria of t h e u n a ntici p ate d pr o ble m 
d efi niti o n d es cri be d i n s e cti o n 9. 5, t h e n a U P s h o ul d b e re p orte d t o t h e S p o ns or wit h o ut 
u nj ustifie d d ela y. F urt h er m ore, re p orti n g of a n u na ntici p ate d pr o ble m t o t h e I R B s h o ul d 
o c c ur wit hi n 1 0 b usi n ess d a ys of dis c o ver y b y t h e I n v esti gat or or S p o ns or Re pres e ntati v e 
re p orti n g t h e e v e nt. T h e I R B will re p ort u n a ntici p ate d pr o ble ms t o t h e a p pr o priate re g ulat or y 
a ge n cies a n d t o t h e i nstit uti o n al official/s p o nsor, as a p pr o priate.  
  
9. 1 1  
P R E G N A N C Y  
D uri n g t h e st u d y, all f e m ale s u bje cts of c hil d be ari n g p ote ntial s h o ul d b e i nstr u cte d t o c o ntact 
t h e i n v esti gat or i m m e diatel y if t h e y s us p ect t h e y mi g ht b e pre g n a nt (e. g., miss e d or late 
m e nstr u al p eri o d).  Fe m ale s u bje cts w h o b e c o m e pre g n a nt d uri n g t h e st u d y will b e f oll o w e d 
u ntil c o m pleti o n of pre g n a nc y. E v er y eff ort will b e m a d e t o o btai n t h e h e alt h stat us of t h e 
m ot h er a n d i nf a nt or f et us (i n c as es of mis c arria ge or t h era p e utic a b orti o n) at ter m.  
Pre g n a n c y its elf is n ot c o nsi d ere d a n A E.  
 
All c o nfir m e d pre g n a n cies m ust b e i m m e diatel y re p orte d t o t h e S p o ns or  wit hi n 4 8  h o urs of 
t h e i n v esti gat or’s a w are n ess of t h e pre g n a nc y.  
 
9. 1 2  
P O T E N TI A L A D V E R S E E V E N T S  
T h e f oll o wi n g h a v e b e e n i d e ntifie d as p ote ntial a d v ers e e v e nts f or all c atara ct s ur geries 
i n cl u di n g t h e L A L . Ple as e n otif y  t h e S p o ns or re gar di n g a n y e v e nts t h at m a y b e o c c urri n g 
m ore fre q u e ntl y t h a n y o ur c ust o m ar y rates, or m ore fre q ue ntl y t h a n e x pe cte d at  y o ur site.   
 
Inf e cti o n, i nfla m mati o n, h y p o p y o n, e n d o p ht hal mitis, i nfe cti o us k eratitis, h y p he m a, reti n al 
d eta c h m e nt or ot h er reti n al pr o ble ms i n cl u di n g c yst oi d m a c ular e d e ma a n d e pireti n al 
m e m bra n es, t o xic a nteri or s e g m e nt s y n dr o m e, gla u c o m a, c or n eal e n d oth elial d a m a ge,  vitritis,  
c or n e al e d e m a  w hic h m a y re q uire c orre cti o n wit h a c or n e al tra ns pla nt , le ns disl o c ati o n o ut of 
t h e p osteri or c h a m b er, p u pillar y bl o c k, striati o n o n t h e le ns wit h or wit h o ut vis u al s e q u elae, 
iritis, s y n e c hia e, pt osis, w o u n d le a k, fla t a nteri or c ha m ber, i n creas e d asti g m atis m, r u pt ure of 
t h e c a ps ule, iris pr ola ps e, vitre o us i n t h e a nteri or c h a m b er, a n d retai ne d pie ces of t h e le ns i n 
t h e e y e. T h es e a d v ers e  e v e nts  m a y res ult i n t otal l oss of visi o n or t h e l oss of a n e y e.  I n c as es 
of m o n o visi o n, i n d uc e d stra bis m us m a y o cc ur. Se c o n dar y s ur ger y m a y b e re q uire d after t h e 
c atara ct s ur ger y t o tre at s ur gic al c o m plic ati o ns. A d diti o nall y, a p osteri or c a ps ul ot o m y m a y 
b e re q uire d t o tre at p osteri or c a ps ular h a z e after t h e c atara ct s ur ger y. Vis u al pr o ble ms after 
c atara ct s ur ger y m a y i n cl u d e h al os, glare , g h ost i m a ges, a n d/ or d o u ble visi o n.  T h es e a n d 
ot h er c o m plic ati o ns m a y res ult i n p er m a n e nt p o or visi o n.    
 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 5 0  
 
 
A d diti o n al s p e cific ris ks of t h e L A L  i n cl u d e: 
I n or d er t o p erf or m t h e le ns a dj ust m e nt or t h e le ns l o c k-i n pr o c e d ures, t h e s u bje ct’s p u pil 
n e e ds t o b e a d e q u atel y dilate d. If t his c a n n ot b e a c c o m plis he d f or a n y re as o n, a d diti o n al e y e 
dr o ps, i nje cti o ns i nt o t h e e y e, or s ur ger y m a y n e e d t o b e utiliz e d t o a d e q uatel y dilate t h e 
p u pil. If t h e p u pil c a n n ot b e a d e q uatel y dilate d after t h es e t y p es of tre at m e nts, t h e L A L  m a y 
n e e d t o b e e x pla nte d. A n u n pre dicte d c h a n ge i n visi o n c a n o c c ur res ulti n g fr o m o c ular 
e x p os ure t o d a yli g ht  or a n y ot h er U V s o urce  b ef ore t h e  L A L  is l o c k e d-i n. T h e li g ht 
tre at m e nts m a y n ot i m pr o v e visi o n a n d/ or m a nifest refra cti o n, a n d t h e a dj ust m e nt/l o c k-i n 
pr o c e d ure m a y m a ke visi o n w ors e, s u c h t h at it m a y b e n e c essar y t o re m o ve a n d re pla c e t h e 
L A L . Visi o n l oss m a y b e p er m a n e nt a n d m a y n ot b e i m pr o ve d b y re pla ci n g t h e L A L . T h ere 
is a p ote ntial ris k f or U V-i n d u c e d d a m a ge t o t h e e y e, i n cl u di n g t h e c or n e a a n d reti n a, w hic h 
m a y b e p er m a n e nt. U V li g ht c a n s o m eti m es c a us e a re a cti v ati o n of pre vi o us h er p e s vir us 
i nf e cti o n i n t h e e y e. A re a cti v ati o n of h er p es vir us c a n c a us e s c arri n g of t h e c or n ea , bl ur re d 
visi o n, e y e p ai n, e xtre m e li g ht s e nsiti vit y, p er m a n e nt l oss of vis i o n, a n d p ossi ble n e e d f or 
c or n e al tra ns pla nt.  Te m p orar y or p ersiste nt er yt hr o psia  a n d/ or te m p orar y or p ersiste nt c ol or 
visi o n d eficie n c y  m a y  o c c ur. C or n e al dr y n ess a n d c or n e al a brasi o ns fr o m t h e le ns us e d f or 
a dj ust m e nt a n d l o c k -i n c a n o c c ur. After t h e le ns a dj ust me nt(s) or after t h e le ns l o c k-i n 
pr o c e d ures, dis c o mf ort, itc hi n g a n d li g ht s e nsiti vit y m a y o c c ur. I n c as es w h ere a 
s p h er o c yli n der a dj ust me nt is p erf or m e d, it is p ossi ble t h at vis u al dist ur b a n ces m a y o c c ur if 
t h e I O L r otates or if t h e c orre cti o n is n ot p erf or me d o n t h e c orre ct a xis of asti g m atis m.   
 
9. 1 3  
P O T E N TI A L B E N E FI T S  
T h e b e n efit t o s u bje cts is t h e p ote ntial c orre cti o n of t h eir 0. 5 0 D resi d u al asti g m atis m. 
H o w e v er, t h es e res ults c a n n ot b e g u ara nte e d. . 
 
 
 

P R O T O C O L #  C S P -0 3 4  
V E R SI O N 0 4  
R X S I G H T, IN C . 
C O N FI D E N TI A L     
P A G E 5 1  
 
 
1 0  
S T U D Y M O NI T O RI N G  
R x Si g ht  cli nic al p ers o n n el or d esi g n ate d C R O will m o nit or all cli nic al st u dies i n a m a n n er 
c o nsiste nt wit h a n y a p plic a ble h e alt h a ut h orit y re g ulati o ns a n d t h e cli nic al res e arc h sta n dar ds 
a d o pte d b y R x Si g ht 's Cli nic al Aff airs D e p art me nt. St u d y m o nit ori n g will i n v ol ve t h e 
f oll o wi n g ele m e nts:  
•  Me m b er(s) of R x Si g ht’s  Cli nic al Aff airs D e p art me nt or d esi g n ate d C R O m a y m e et 
wit h i n v esti gat ors pri or t o t h e i nitiati o n of t h e st u d y i n or d er t o re vie w t h e a d e q ua c y 
of t h e s u bje ct p o p ulati o n, f a cilities, a n d e q ui p m e nt wit h res p e ct t o t h e n e e ds of t h e 
st u d y, a n d t o f a miliariz e t h e i n v esti gat or wit h t h e st u d y pr ot o c ol.  
•  A m e m b er of R x Si g ht’s  Cli nic al Aff airs D e p art me nt or d esi g n ate d C R O m a y m e et 
wit h t h e i n v esti gat or(s) at t h e ti m e st u d y s u bje cts b e gi n t o b e e nr olle d i n or d er t o 
e n s ure t h at s u bje cts are b ei n g pr o p erl y s ele cte d a n d t h at st u d y d ata are b ei n g 
c orre ctl y re c or d e d.  
•  A m e m b er of R x Si g ht or d esi g n ate d C R O m a y visit t h e cli nic al site at a n y ti m e 
d uri n g t h e st u d y t o re vie w st u d y w or ks h eets a n d d ata e ntere d i n t h e E D C s yste m.  
•  I nteri m m o nit ori n g visits a n d tele p h o n e c o ns ultati o ns will o c c ur as n e c ess ar y d uri n g 
t h e c o urs e of t h e st u d y t o e ns ure t h e pr o per pr o gress a n d d o c u m e ntati o n of t h e st u d y 
fi n di n gs. Ce ntraliz e d a n d/ or re m ote m o nit ori n g m a y b e p erf or me d d uri n g t h e 
c o n d u ct of t h e st u d y.   
•  R x Si g ht cli nic al p ers o n n el m a y visit t h e site at a n y ti m e d uri n g t h e c o urs e of t h e 
st u d y t o o bs er v e t h e a dj ust m e nt a n d l o c k-i n tre at m e nts t o e ns ure t h at t h e pr o c e d ures 
d es cri b e d i n t h e pr ot o c ol are b ei n g f oll o w e d.  
•  R x Si g ht cli nic al p ers o n n el m a y als o o bs er ve e x a mi n ati o n te c h ni q ues us e d b y st u d y 
p ers o n n el t o e ns ure t h at t h e pr o ce d ures b ei n g utiliz e d are t h e pr o c e d ures d es cri b e d i n 
A p p e n di x 1 of t h e pr ot o c ol.  
  
 
 

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R X S I G H T, IN C . 
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1 1  
E T HI C A L A N D R E G U L A T O R Y C O N SI D E R A TI O N S  
1 1.1  
S U B J E C T IN F O R M A TI O N A N D C O N S E N T  
It is t h e res p o nsi bilit y of t h e Pri n ci p al I n v esti gat or or a ut h oriz e d d esi g n e e t o gi v e e a c h 
s u bje ct pri or t o i n cl usi o n i n t h e st u d y f ull a n d a d e q u ate v er b al a n d writte n i nf or m ati o n 
re gar di n g t h e o bje cti v e a n d pr o c e d ures of t h e st u d y a n d t h e p ossi ble ris ks i n v ol ve d.  T h e 
s u bje cts will b e i nf or m e d a b o ut t h eir ri g ht t o ref us e t o p artici p ate i n t h e st u d y.  T h e writte n 
c o ns e nt f or m will b e gi v e n t o e a c h s u bje ct b ef ore e nr oll m e nt.  It is t h e res p o nsi bilit y of t h e 
Pri n ci p al I n v esti gat or t o o btai n a si g n e d i nf or m e d c o ns e nt f or m a n d a HI P A A c o ns e nt f or m  
(if re q uire d) a n d t o e ns ure t h e s u bje ct is gi v e n a c o p y of e a c h. 
 
T h e Pri n ci p al I n v esti gat or or a ut h oriz e d d esi g n ee n e e ds t o file t h e i nf or m e d c o ns e nt f or ms 
f or re vie w b y R x Si g ht st u d y m o nit ors.  T h e I n v esti gat or or a ut h oriz e d d esi g n e e will 
a c k n o wle d ge t h e re c ei pt of t h e i nf or m e d c o ns e nt f or m fr o m e a c h s u bje ct b y si g ni n g t h e 
a p pr o priate p a ges of t h es e d o c u m e nts . 
 
1 1.2  
D E C L A R A TI O N O F H E L SI N KI  
T h e st u d y will b e p erf or m e d i n a c c or d a nc e wit h t h e rele v a nt re c o m m e n dati o ns g ui di n g 
p h ysicia ns i n bi o m e dic al res e arc h i n v ol vi n g h u m a n s u bje cts a d o pte d b y t h e 1 8 th W orl d 
Me dic al Ass e m bl y, H elsi n ki, Fi nla n d, 1 9 6 4 a n d later re visi o n s, as w ell as a p plic a ble U. S. 
F o o d a n d Dr u g A d mi nistrati o n re g ulati o ns ( 2 1 C F R Parts 5 0, 5 6, a n d 8 1 2).  
 
It is t h e res p o nsi bilit y of t h e Pri n ci p al I n v esti gat or t o o btai n I nstit uti o nal Re vie w B o ar d 
a p pr o v al of t h e St u d y Pr ot o c ol  a n d relate d st u d y d o c u m e nts  a n d t o k e e p t h e I R B i nf or me d of  
a n y u n a ntici p ate d pr o ble ms  a n d a n y a m e n d m e nts t o t h e pr ot o c ol.  
 
1 1.3  
I S O 1 4 1 5 5: 2 0 1 1  C LI NI C A L IN V E S TI G A TI O N O F M E DI C A L D E VI C E S F O R H U M A N 
S U B J E C T S - G O O D C LI NI C A L P R A C TI C E  
T his st u d y s h o ul d b e p erf or m e d i n c o m plia n ce wit h I S O 1 4 1 5 5: 2 0 1 1.  
 
1 1.4  
A D DI TI O N A L R E G U L A T O R Y C O N SI D E R A TI O N S  
T h e pr o p os e d st u d y is s u bje ct t o all a p plic a ble g o v er n m e ntal r ules a n d re g ulati o ns 
c o n c er ni n g t h e c o n d uct of cli nic al trials o n h u m a n s u bje cts.  T his i n cl u d es, b ut is n ot 
n e c ess aril y li mite d t o, t h e a p pr o v al of a n I nstit uti o n al Re vie w B o ar d ( w h ere a p plic a ble); 
o btai ni n g pr os p e cti v e i nf or m e d c o ns e nt; m o nit ori n g of t h e c o n d uct of t h e st u d y, t h e 
c o m plete n ess of t h e st u d y w or ks he ets, a n d a c c ura c y of d ata e ntere d i nt o t h e E D C s yste m, as 
m a y b e e m pl o y e d, b y t h e S p o ns or or its d esi g n e e(s); a n d re c or d rete nti o n b y t h e S p o ns or i n 
a c c or d a n c e wit h 2 1 C F R S u b p art G -Re c or ds a n d Re p orts.  
 
1 1.5  
S T U D Y INI TI A TI O N / CO N D U C T  
T h e st u d y will n ot c o m m e n c e u ntil  ( 1) a p pr o val is o btai n e d fr o m t h e I R B a n d a p pr o priate 
re g ulat or y a ut h orities a n d  ( 2) writte n p er missi o n is gi v e n b y t h e S p o ns or. A n y a d diti o n al 
re q uire m e nts i m p os e d b y t h e I R B or ot h er a p pr o priate re g ulat or y a ut h orities s h all b e 
f oll o w e d. 

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R X S I G H T, IN C . 
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1 1.6  
C O M P LI A N C E WI T H T H E C LI NI C A L S T U D Y P R O T O C O L  
T h e I n v esti gat or s h all c o n d u ct t his cli nic al i n v esti ga ti o n i n a c c or d a n c e wit h t h e si g n e d 
a gre e m e nt wit h t h e S p o ns or, t h e i n v esti gati o n al pla n, a n d t h e a p plic a ble re g ulati o ns. T h e 
I n v esti gat or s h all a v oi d i m pr o p er i nfl u e n ce o n or i n d uc e me nt of t h e s u bje ct, S p o ns or, 
M o nit or, ot h er I n v esti gat or(s) or ot h er p arti es p artici p ati n g i n or c o ntri b uti n g t o t h e cli nic al 
i n v esti gati o n.  
 
1 1.7  
P R O T O C O L D E VI A TI O N S ( P DS ) 
Pr ot o c ol d e viati o ns s h o ul d b e a v oi d e d.  A n y d e viati o n fr o m t h e pr ot oc ol will b e re c or d e d o n 
a Cas e Re p ort F or m t o get h er wit h a n e x pla n ati o n f or t h e d e viati o n.  D e viati o ns s h o ul d b e 
re p orte d t o t h e S p o ns or, w h o is res p o nsi ble f or a n al y zi n g t h e m a n d ass essi n g t h eir 
si g nific a n c e. 
 
D e viati o ns s h o ul d b e re vie w e d t o d eter mi n e t h e n ee d t o a m e n d t h e pr ot oc ol or t o ter mi n ate 
t h e i n v esti gati o n. 
 
N O T E:  T h e I R B a n d C o m p ete nt  A ut h orities or t h e a p pr o priate re g ulat or y b o dies will b e 
i nf or m e d of pr ot o c ol d e viati o ns p er a p plic a ble re p orti n g re q uire me nts . 
 
1 1.8  
P R O T O C O L A M E N D M E N T S  
M o dific ati o n of t h e pr ot o c ol is pr o hi bite d wit h o ut pri or writte n a gre e m e nt i n t h e f or m of a 
pr ot o c ol a m e n d me nt. All a m e n d m e nts will b e cre ate d b y t h e S p o ns or a n d m ust b e a p pr o ve d 
b y t h e I R B or ot h er re g ulat or y b o dies as n e e de d pri or t o i m ple m e ntati o n e x ce pt w h e n 
re q uire d t o miti gate i m m e diate s af et y ris ks or w h e n t h e c h a n ges i n v ol v e o nl y l o gistic al or 
a d mi nistrati v e re visi o ns. All pr ot o c ol a m e n d m e nts m ust b e cle arl y s u m mariz e d t o o utli n e t h e 
c h a n ges t h at w ere m a d e.  
 
1 1.9  
P U B LI C A TI O N P O LI C Y  
T h e fi n al re p ort of t h e st u d y will b e a v aila ble t o t h e I R B a n d a p pr o priate  re g ulat or y 
a ut h orities .  
 
1 1.1 0  IN S U R A N C E A N D  IN D E M NI T Y  
T h e S p o ns or s h all e ns ure t h at a c c e pta ble i ns ura nc e a n d i n d e m nific ati o n is i n pla c e pri or t o 
e nr oll m e nt of t h e first st u d y s u bje ct.  
 
 
 
 

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1 2  
R E F E R E N C E S 
1.  C o nra d- H e n gerer I, Al S h ei k h M, H e n gerer F H, et. al. C o m p aris o n of vis ual 
re c o v er y a n d refra cti ve sta bilit y b et w e e n f e mt ose c o n d las er-assiste d c atara ct 
s ur ger y a n d sta n d ar d p h ac o e m ulsificati o n: Si x -m o nt h f oll o w -u p. J Catara ct 
Refra ct S ur g 2 0 1 5; 4 1: 1 3 5 6 -1 3 6 4.  
2.  Bara n y o vits P. Sta bilis ati o n of refracti o n f oll o wi n g c atara ct s ur ger y. Britis h 
J o ur nal of O p ht h al m ol o g y, 1 9 8 8, 7 2, 8 1 5-8 1 9.  
3.  Mal vi n a B. E y d el m a n, et al. “ Sta n d ariz e d A n al ys es of C orre cti o n of Asti g m atis m 
b y Las er S yste ms t h at Res h a p e t h e C or n e a ”, J o ur nal of Refracti v e S ur ger y 
V ol u m e 2 2 J a n u ar y/ Fe br u ar y 2 0 0 6, p p 8 1 -9 5 .