Optimizing the Assessment of Refractive Outcomes After Cataract Surgery and Implantation of a Monofocal IOL
Phase: NA
Conditions: Cataract
Sponsor: Alcon Research

P a g e  1 of  5 4
a  N o v arti s  c o m p a n y
S h ort  Ti tl e
O pti mi zi n g  t h e Ass ess m e nt  of  R ef r a cti v e O ut c o m es  aft e r C at a r a ct  S u r g e r y
L o n g  T itl e
O pti mi zi n g  t h e Ass ess m e nt  of  R ef r a cti v e O ut c o m es  aft e r C at a r a ct  S u r g e r y 
a n d I m pl a nt ati o n  of  a  M o n of o c al I O L
Pr ot o c ol  N u m b er: 
St u d y   P h as e:
S p o ns or  N a m e  &  A d dr ess:
Te st  Pr o d u ct:
U S  I ND # / I D E #/  E u dr a C T :
I L Q 7 3 2-I0 0 1  / N C T 0 2 8 4 2 1 5 1
N ot A p plica ble
Alc o n Researc h, Lt d. a n d its af filiates (“ Alc o n”) 
6 2 0 1  S o ut h Free wa y
F ort W ort h, T e xas  7 6 1 3 4 - 2 0 9 9
A C R Y S O F ®  I Q M o n of ocal I O L ( M o del S N 6 0 W F) 
N ot A p plica ble
I n v esti g at or A gr e e m e nt
Pri n ci p al I n v esti g at or
N a m e
A d dr ess
I  h a v e r e a d t h e  cli ni c al st u d y  d es cri b e d,  h er ei n, 
r e c o g ni z e its  c o nfi d e nti alit y. I  a gr e e t o  c o n d u ct t his 
st u d y i n  a c c or d a n c e  wit h t h e  et hi c al  pri n ci pl es  c o nt ai n e d 
wit hi n t h e  D e cl ar ati o n  of  H elsi n ki,  a n d t h e  d es cri b e d 
st u d y i n  c o m pli a n c e  wit h t h e  pr ot o c ol,  G o o d  Cli ni c al 
Pr a cti c es ( G C P), I S O  1 4 1 5 5,  a n d  all  a p pli c a bl e 
r e g ul at or y r e q uir e m e nts. A d diti o n all y , I  will  c o m pl y 
wit h  all  pr o c e d ur es f or  d at a r e c or di n g  a n d r e p orti n g,  will 
p er mit  m o nit ori n g,  a u diti n g,  a n d i ns p e cti o n  of  m y 
r es e ar c h  c e nt er,  a n d will r et ai n  all r e c or ds  u ntil  n otifi e d 
b y  t h e  St u d y  S p o ns or.
Si g n at ur e
D at e
Pr o p ert y  of  Al c o n  L a b or at ori es
C o nfi d e nti al
M a y  n ot  b e  us e d,  di v ul g e d,  p u blis h e d,  or  ot h er wis e  dis cl os e d  wit h o ut t h e  c o ns e nt  of  Al c o n 
L a b or at ori es
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  2 of  5 4
T A B L E  O F   C O N T E N T S
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
T A B L E  O F  C O N T E N T S ........................................................................................................... 2
List  of  Ta bl es .............................................................................................................................. 5
List  of  Fi g ur es ............................................................................................................................ 5
1   
G L O S S A R Y  O F  T E R M S ....................................................................................... 6
2 
A B B R E VI A TI O N S ................................................................................................ 9
3 
P R O T O C O L   S U M M A RY.................................................................................... 1 0
4 
P R O T O C O L   AM E N D M E N T S ............................................................................ 1 3
5 
S C H E D U L E  O F  P R O C E D U R E S  A N D  A S S E S S M E N T S .................................. 1 4
6 
I NT R O D U C TI O N ................................................................................................ 1 5
6. 1 
R ati o n al e  a n d  B a c k gr o u n d ............................................................................... 1 5
6. 2 
P ur p os e  of t h e  St u d y ......................................................................................... 1 6
6. 3   
Ris ks  a n d  B e n efits ............................................................................................ 1 6
7 
S T U D Y   O BJ E C TIV E S ........................................................................................ 1 7
7. 1 
Pri m ar y   O bj e cti v e............................................................................................. 1 7
7. 1. 1
Pri m ar y   Eff e cti v e n ess E n d p oi nts ................................................................. 1 7
7. 1. 2
Pri m ar y   Eff e cti v e n ess  Ass ess m e nts ............................................................. 1 7
7. 2
..................................................................................... 1 8
7. 3 
S af et y   O bj e cti v e ............................................................................................... 1 8
7. 3. 1
S af et y  E n d p oi nt ............................................................................................ 1 8
7. 3. 2
A d diti o n al  S af et y   Ass ess m e nts .................................................................... 1 8
8 
I NV E S TI G A TI O N A L   P L A N ............................................................................... 1 9
8. 1 
St u d y   D esi g n .................................................................................................... 1 9
8. 2 
R ati o n al e f or  St u d y   D esi gn .............................................................................. 2 0
8. 3 
R ati o n al e f or  d ur ati o n  of tr e at m e nt/f oll o w - u p ................................................. 2 0
8. 4 
D at a  M o nit ori n g  C o m mitt e e ............................................................................ 2 0
8. 5 
P ur p os e  a n d  T i mi n g  of I nt eri m A n al ys es  a n d  R es ulti n g  D esi g n  A d a pt ati o ns .. 2 0
9 
S U BJ E C T   P O P U LA T I ON.................................................................................... 2 0
9. 1 
I ncl usi o n  Crit eri a.............................................................................................. 2 1
9. 2 
E x cl usi o n  Crit eri a ............................................................................................. 2 1
9. 3 
E x cl usi o n  Crit eri a  at  Ti m e  of S ur g er y .............................................................. 2 3
9. 4 
R es cr e e ni n g  of  S u bj e cts ................................................................................... 2 3

P a g e  3 of  5 4
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
1 0 
T R E A T M E N T ...................................................................................................... 2 3
1 0. 1 
I n v esti g ati o n al  Pr o d u ct ..................................................................................... 2 3
1 0. 1. 1 
Ot h er  M e di c al  D e vi c e  S p e cifi e d f or  Us e  D uri n g t h e  St u d y ......................... 2 5
1 0. 2 
Tr e at m e nt Assi g n m e nt /  R a n d o mi z ati o n .......................................................... 2 5
1 0. 3 
A c c o u nt a bilit y   Pr o c e d ur es ............................................................................... 2 5
1 0. 4 
Tr e at m e nt  M as ki n g ........................................................................................... 2 6
1 0. 5 
C h a n g es t o  C o n c o mit a nt  T r e at m e nts  or  Pr o c e d ur es......................................... 2 6
1 1 
S T U D Y   P R O C E D U R E S A N D  A S S E S S M E N T S  B Y   VI SI T .............................. 2 6
1 1 . 1 
S cr e e ni n g/ Pr e o p er ati v e  V isit ( Visit  0).............................................................. 2 7
1 1 . 2 
O p er ati v e  V isit ( Visit  0 0).................................................................................. 2 8
1 1 . 3 
P ost o p er ati v e  V isit ( Visit  1).............................................................................. 2 9
1 1 . 4 
P ost o p er ati v e  V isit ( Visit  2).............................................................................. 3 0
1 1 . 5 
S c h e d ul e  of  Pr o c e d ur es  a n d  Ass ess m e nts f or  Dis c o nti n u e d  S u bj e cts .............. 3 1
1 1 . 6 
I nf or m e d  C o ns e nt  a n d  S cr e e ni n g ..................................................................... 3 2
1 1 . 7 
U ns c h e d ul e d  V isits ........................................................................................... 3 2
1 1 . 8 
Dis c o nti n u e d  S u bj e cts ...................................................................................... 3 4
1 1 . 8. 1 
S cr e e n  F ail ur es ............................................................................................. 3 4
1 1 . 8. 2 
Dis c o nti n u ati o ns ........................................................................................... 3 4
1 1 . 9 
Cli ni c al  St u d y   Ter mi n ati o n ............................................................................... 3 5
1 1 . 1 0 
A b ort e d I m pl a nt ati o n ....................................................................................... 3 5
1 1 . 1 0. 1 
A b ort e d I niti al I m pl a nt ati o n ......................................................................... 3 5
1 1 . 1 0. 2   
A b ort e d  S e c o n d I m pl a nt ati o n....................................................................... 3 6
1 2 
D E VI C E  D E FI CI E N CI E S  A N D  A D V E R S E  E V E N T S ....................................... 3 6
1 2. 1   
G e n er al I nf or m ati o n ......................................................................................... 3 6
1 2. 2  
S eri o us  A d v ers e  E v e nts .................................................................................... 3 7
1 2. 3 
S p e cifi c  E v e nts  R el e v a nt t o t his  Pr ot o c ol ........................................................ 3 8
1 2. 3. 1 
C u m ul ati v e  S eri o us  A d v ers e  E v e nts ............................................................ 3 8
1 2. 3. 2  
P ersist e nt  S eri o us  A d v ers e  E v e nts ............................................................... 3 8
1 2. 4 
Te r mi n ol o g y ..................................................................................................... 3 9
1 2. 4. 1 
A d v ers e  D e vi c e  Eff e ct .................................................................................. 3 9
1 2. 4. 2  
S eri o us  A d v ers e  D e vi c e  Ef f e ct ..................................................................... 3 9
1 2. 4. 3 
A nti ci p at e d  S eri o us  A d v ers e  D e vi c e  Ef f e ct ................................................. 3 9
1 2. 4. 4 
U n a nti ci p at e d  S eri o us  A d v ers e  D e vi c e  Ef f e ct ............................................. 3 9
1 2. 4. 5 
D e vi c e  D efi ci e n ci es ...................................................................................... 3 9
1 2. 5 
R et ur n  Pr o d u ct  A n al ys is................................................................................... 4 0

P a g e  4 of  5 4
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
1 2. 6 
M o nit ori n g f or  A d v ers e  E v e nts ........................................................................ 4 0
1 2. 7  
Pr o c e d ur es f or  R e c or di n g  a n d  R e p orti n g ......................................................... 4 0
1 2. 7. 1 
I nt e nsity  a n d  C a us alit y  Ass ess m e nts ............................................................ 4 2
1 2. 7. 1. 1 
C a us alit y ................................................................................................... 4 2
1 2. 7. 1. 2 
I nt e nsity ( S e v erit y) ................................................................................... 4 2
1 2. 8 
U n m as ki n g  of t h e  St u d y  Inf or m ati o n ............................................................... 4 2
1 2. 9 
F oll o w -U p  of  S af et y  I nf or m ati o n ..................................................................... 4 3
1 2. 1 0 
Pr e g n a n c y  i n t h e  Cli ni c al  St u d y....................................................................... 4 3
1 3 
A N A L Y SI S  P L A N ............................................................................................... 4 3
1 3. 1 
S u bj e ct  E v al u a bilit y ......................................................................................... 4 3
1 3. 2 
A n al y sis  D at a  S ets ............................................................................................ 4 3
1 3. 2. 1 
S af et y   An al y sis  S et ....................................................................................... 4 3
1 3. 2. 2 
All I m pl a nt e d  A n al ys is  S et ( A A S) ............................................................... 4 3
1 3. 2. 3 
B est  C as e  A n al ys is  S et ( B A S)...................................................................... 4 3
1 3. 3   
D e m o gr a p hi cs  a n d  B as eli n e  C h ar a ct eristi cs .................................................... 4 4
1 3. 4 
Ef f e cti v e n ess A n al ys es ..................................................................................... 4 4
1 3. 4. 1 
Pri m ar y   Eff e cti v e n ess................................................................................... 4 4
1 3. 4. 1. 1 
St atisti c al  H y p ot h es es ............................................................................... 4 5
1 3. 4. 1. 2 
A n al y sis  M et h o ds ..................................................................................... 4 5
1 3. 4. 2 
S e c o n d ar y   Eff e cti v e n ess............................................................................... 4 5
1 3. 4. 2. 1 
St atisti c al  H y p ot h e s es ............................................................................... 4 5
1 3. 4. 2. 2 
A n al y sis  M et h o ds ..................................................................................... 4 5
1 3. 4. 3
............................................................................ 4 5
1 3. 4. 3. 1
............................................................. 4 6
1 3. 4. 3. 2
..................................................................................... 4 6
1 3. 5   
H a n dli n g  of  Missi n g  D at a ................................................................................ 4 7
1 3. 6 
M ulti pli cit y ....................................................................................................... 4 7
1 3. 7 
S af et y   An al y sis ................................................................................................. 4 8
1 3. 8 
I nt eri m A n al ys es ............................................................................................... 4 8
1 3. 9 
A d a pti v e  St u d y   D esi g n..................................................................................... 4 8
1 3. 1 0 
S a m pl e  Si z e J ustifi c ati o n .................................................................................. 4 8
1 4 
D A T A  H A N D LI N G  A N D  A D MI NI S T R A TI V E  R E Q UI R E M E N T S .................. 4 9
1 4. 1 
S u bj e ct  C o nfi d e nti alit y ..................................................................................... 4 9
1 4. 2 
C o m pl eti o n  of  S o ur c e  D o c u m e nts  a n d  C as e  R e p ort  F or ms ............................. 5 0
1 4. 3   
D at a  R e vi e w  a n d  Cl arifi c ati o ns........................................................................ 5 1

P a g e  5 of  5 4
1 4. 4 
S p o ns or  a n d  M o nit or i n g  R es p o nsi biliti es ........................................................ 5 1
1 4. 5 
R e g ul at or y   D o c u m e nt ati o n  a n d  R e c or ds  R et e nti o n ......................................... 5 1
1 4. 6 
Q u alit y   Ass ur a n c e  a n d  Q u alit y  C o ntr ol............................................................ 5 2
1 5 
E T HI C S ................................................................................................................ 5 2
1 6 
R E F E R E N C E S ..................................................................................................... 5 4
List  of  Ta bl es
Ta bl e 8 – 1 
S c h e d ul e  of  St u d y   Visits .................................................................................. 2 0
Ta bl e 1 0 – 1 
Te st Arti cl e ....................................................................................................... 2 3
List  of  Fi g u r es
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
Fi g ur e 8 – 1 
St u d y   D esi g n.................................................................................................... 1 9
Fi g ur e  1 2 – 1   
C at e g ori z ati o n  of  All  A d v ers e  E v e nts .............................................................. 3 6
Fi g ur e  1 2 – 2   
C at e g ori z ati o n  of  All  S eri o us  A d v ers e  E v e nt s................................................. 3 7
Fi g ur e 1 3 – 1 
C u m ul ati v e  L i n e  Pl ot....................................................................................... 4 7

P a g e  6 of  5 4
1 
G L O S S A R Y  O F   TE R M S
A C R Y S O F I Q  M o n of o c al 
I OL
T hr o u g h o ut t his  d o c u m e nt, i n v esti g ati o n al  pr o d u ct  will  b e 
r ef err e d t o  as A C R Y S O F I Q  M o n of o c al I O L  
( M o d el S N 6 0 W F),  M o d el  S N 6 0 W F  a n d  Te st Arti cl e .
A d v ers e  D e vi c e  Ef f e ct 
( A D E)
A d v ers e  e v e nt r el at e d t o t h e  us e  of  a n  i n v esti g ati o n al  m e di c al 
d e vi c e (t est  arti cl e)  or  c o ntr ol  arti cl e. N ot e:  T his  d efi niti o n 
i n cl u d es  a d v ers e  e v e nts res ulti n g fr o m i ns uffi ci e nt  or 
i n a d e q u at e i nstr u cti 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;  a n y  m alf u n cti o n;  a n d  us e  error  or 
i nt e nti o n al  mis us e  of t h e t est  arti cl e  or  c o ntrol  arti cl e .
A d v ers e  E v e nt ( A E) 
A n y   u nt o w ar d  m e di c al  o c c urr e n c e,  u ni nt e n d e d  dis e as e  or 
i nj ur y,  or  u nt o w ar d  cli ni c al si g ns (i n cl u di n g  a b n or m al 
l a b or at or y fi n di n gs) i n s u bj e cts,  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 n v esti g ati o n al  m e di c al  d e vi c e 
(t est arti cl e).  N ot e:  F or s u bj e cts, t his  d efi niti o n i n cl u d es 
e v e nts r el at e d t o t h e t est  arti cl e, t h e  c o ntr ol  arti cl e,  or t h e 
pr o c e d ur es i n v ol v e d.  F or  us ers  or  ot h er  p ers o ns, t his 
d efi niti o n is r estri ct e d t o  e v e nts r el at e d t o t h e t est  arti cl e.
A nti ci p at e d  S eri o u s 
A d v ers e  D e vi c e  Ef f e ct 
( A S A D E)
S eri o us  a d v ers e  d e vi c e  eff e ct  w hi c h  b y its  n at ur e, i n ci d e n c e, 
s e v erit y  or  o ut c o m e  h as  b e e n i d e ntifi e d i n t h e ris k 
m a n a g e m e nt fil e.
D e vi c e  D efi ci e n c y 
I na d e q u a c y   of  a  m e di c al  d e vi c e  wit h r es p e ct t o its i d e ntit y, 
q u alit y ,  d ura bilit y, r eli a bilit y, s af et y,  or  p erf or m a n c e. N ot e: 
T his  d efi niti o n i n cl u d es  m alf u n cti o ns,  us e  err ors,  a n d 
i n a d e q u at e l a b eli n g.
E nr oll e d  S u bj e cts
A n y  s u bj e ct  w h o si g ns  a n i nf or m e d  c o ns e nt f or m (IC F)  f or 
p arti ci p ati o n i n t h e st u d y .
I nt er v e nti o n al  St u d y 
A  st u d y i n  w hi c h  pr os p e cti v e s u bj e ct assi g n m e nt is  d e ci d e d 
b y   a  pr ot o c ol a n d  us e  of t h e  pr o d u ct is li n k e d t o t h e  d e cisi o n 
t o i n cl u d e t h e s u bj e ct i n t h e st u d y. I nt er v e nti o ns i n cl u d e,  b ut 
ar e  n ot r estri ct e d t o,  dr u gs,  c ells  a n d  ot h er  bi ol o gi c al 
pr o d u cts, s ur gi c al  pr o c e d ur es, r a di ol o gi c  pr o c e d ur es,  d e vi c es, 
b e h a vi or al tr e at m e nts,  pr o c ess - of-c ar e  c h a n g es,  a n d 
pr e v e nti v e c ar e . A d diti o n al  di a g n osti c  or  m o nit ori n g 
pr o c e d ur es  ar e  a p pli e d  a n d  m et h o ds  ot h er t h a n
e pi d e mi ol o gi c al  m et h o ds  ar e  b ei n g  us e d f or  a n al ysis  of  t h e 
d at a .
M alf u n cti o n
F ail ur e  of  a n i n v esti g ati o n al  m e di c al  d e vi c e t o  p erf or m i n 
a c c or d a n c e  wit h its i nt e n d e d  p ur p os e  w h e n  us e d i n 
a c c or d a n c e  wit h t h e i nstr u cti o ns f or  us e  or  cli ni c al 
i n v esti g ati o n  pl a n.
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  7 of  5 4
N o ns eri o us  A d v ers e  E v e nt 
A d v ers e  e v e nt t h at  d o es  n ot  m e et t h e  crit eri a f or  a s eri o us 
a d v ers e  e v e nt.
Pr e -s cr e e n e d  S u bj e cts 
C h art r e vi e w  c o m pl et e d o n  p ot e nti al s u bj e cts b y  st u d y sit e 
f or i n cl usi o n/ e x cl usi o n  crit eri a t h at  d o  n ot r e q uir e st u d y 
s p e cifi c t esti n g. T his is  b as e d  o n r o uti n e  cli ni c al t esti n g 
a n d/ or  c at ar a ct  e v al u ati o n.
S cr e e n e d  S u bj e cts 
A n y  s u bj e ct  w h o is  c o nsi d er e d f or t h e st u d y  a n d  m a y  or  m a y 
n ot  h a v e si g n e d a n I CF.
S eri o us  A d v ers e  D e vi c e 
Ef f e ct ( S A D E)
A d v ers e  d e vi c e  ef f e ct t h at  h as r es ult e d i n  a n y  of t h e 
c o ns e q u e n c es  c h ar a ct eristi c  of  a  s eri o us  a d v ers e  e v e nt.
S eri o us  A d v ers e  E v e nt 
( S A E)
A d v ers e  e v e nt t h at l e d t o  a n y   of t h e f oll o wi n g: 
 
D e at h.
 
A  s eri o us  d et eri or ati o n i n  h e alt h t h at  eit h er r es ult e d i n:
a) a lif e -t hr e at e ni n g ill n ess  or i nj ur y.
N ot e:  Lif e -t hre at e ni n g  m e a ns t h at t h e i n di vi d u al  w as 
at i m m e di at e ris k  of  d e at h fr o m t h e  e v e nt  as it 
o c c urr e d, i e, it  d o es  n ot i n cl u d e  a n  e v e nt  w hi c h 
h y p ot h eti c all y  mi g ht  h a v e  c a us e d  d e at h  h a d it 
o c c urr e d i n  a  m or e s e v er e f or m.
b) a n y   p ot e nti all y si g ht-t hr e at e ni n g  e v e nt  or  p er m a n e nt 
i m p air m e nt t o  a  b o d y str uct ur e  or  a  b o d y f u n cti o n.
c) i n-p ati e nt  h os pit ali z ati o n  or  pr ol o n g e d
h os pit ali z ati o n.
N ot e:  Pl a n n e d  h os pit aliz ati o n f or  a  pr e- e xisti n g 
c o n diti o n,  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 e d  a s eri o us  a d v ers e  e v e nt. I n  g e n er al, 
h os pit aliz ati o n si g nifi es t h at t h e i n di vi d u al r e m ai n e d 
at t h e  h os pit al  or  e m er g e n c y  w ar d f or  o bs er v ati o n 
a n d/ or tr e at m e nt ( us u all y i n v ol vi n g  a n  o v er ni g ht 
st a y) t h at  w o ul d  n ot  h a v e  b e e n  a p pro pri at e i n t h e 
p h ysi ci a n's  offi c e  or  a n  o ut -p ati e nt s etti n g. 
C o m pli c ati o ns t h at  o c c ur  d uri n g  h os pit aliz ati o n  ar e 
a d v ers e  e v e nts. If  a  c o m pli c ati o n  pr ol o n gs 
h os pit aliz ati o n  or f ulfills  a n y  ot h er s eri o us  crit eri a, 
t h e  e v e nt is s eri o us. W h e n i n  d o u bt  as t o  w h et h er 
“ h os pit aliz ati o n ”  o c c urr e d, t h e  e v e nt s h o ul d  b e 
c o nsi d er e d s eri o us.
d) a  m e di c al  or s ur gi c al i nt er v e nti o n t o  pr e v e n t  a)  or  b), 
or  a n y  o c ul ar s e c o n d ar y s ur gi c al i nt er v e nti o n 
e x cl u di n g  p ost eri or  c a ps ul ot o m y.
e) a n y  i n dir e ct  h ar m as  a  c o ns e q u e n c e  of i n c orr e ct 
di a g n osti c t est r es ults  w h e n  us e d  wit hi n 
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  8 of  5 4
m a n uf a ct ur er's i nstr u cti o ns f or  us e.
 
F et al  distr ess, f 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 e ct.
R ef er  t o  S e cti o n 1 2  f or  a d diti o n al S A Es.
Si g nifi c a nt  N o n - S eri o us 
A d v ers e  E v e nt
A  si g nifi c a nt  n o n -s eri o us  a d v ers e  e v e nt is  a s y m pt o m ati c, 
d e vi c e -r el at e d,  n o n-si g ht t hr e at e ni n g  a d v ers e  e v e nt t h at 
w arr a nts  dis c o nti n u ati o n  of  a n y  c o nt a ct l e ns  w e ar f or  gr e at er 
t h a n  or  e q u al t o  2  w e e ks.
R ef er t o  S e cti o n  7 f or  a d diti o n al  Si g nifi c a nt  N o n- S eri o us 
A Es.
U n a nti ci p at e d  S eri o us 
A d v ers e  D e vi c e  Ef f e ct 
( U S A D E)
S eri o us  a d v ers e  d e vi c e  eff e ct  w hi c h  b y its  n at ur e, i n ci d e n c e, 
s e v erit y  or  o ut c o m e  h as  n ot  b e e n i d e ntifi e d i n t h e ris k 
m a n a g e m e nt fil e .
Us e  Err or
A ct  or  o missi o n  of  a n  a ct t h at r es ults i n  a  dif f er e nt  m e di c al 
d e vi c e r es p o ns e t h a n i nt e n d e d  b y   m a n uf a ct ur er  or  e x p e ct e d 
b y   us er. N ot e:  T his  d efi niti o n i n cl u d es sli ps, l a ps es,  a n d 
mist a k es.  A n  u n e x p e ct e d  p h ysi ol o gi c al r es p o ns e  of t h e 
s u bj e ct  d o es  n ot i n its elf  c o nstit ut e  a  us e  err or.
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  9 of  5 4
2   
A B B R E VI A TI O N S
A b b r e vi ati o n
D efi niti o n
A A S
All i m pl a nt e d  a n al y sis s et
A C D
A nt eri or  c h a m b er  d e pt h
A D E
A d v ers e  d e vi c e  ef f e ct
A E
A d v ers e  e v e nt
A L
A xi al l e n gt h
A M D
A g e -r el at e d  m a c ul ar  d e g e n er ati o n
A S A D E
A nti ci p at e d s eri o us a d v ers e  d e vi c e  ef f e ct
B A S
B est  c as e  a n al y sis s et
C D V A
C orr e ct e d  dist a n c e  vis u al  a c uit y
C E
E ur o p e a n  C o nf or mit y
CI
C o or di n ati n g I n v esti g at or
D
Di o pt er
D o H
D e cl ar ati o n  of  H elsi n ki
D F U
Dir e cti o ns f or  us e
E D C
El e ctr o ni c  d at a  c a pt ur e
e C R F
El e ctr o ni c  c as e r e p ort f or m
E U
E ur o p e a n  U ni o n
F D A
U S  F o o d  a n d  Dr u g  A d mi nistr ati o n
G C P
G o o d  Cli ni c al  Pr a cti c e
I CF
I nf or m e d  c o ns e nt f or m
I C H
I nt er n ati o n al  C o nf er e n c e  o n  H ar m o ni z ati o n
I E C
I n d e p e n d e nt  Et hi cs  Co m mitt e e
I OL
I ntr a o c ul ar l e ns
I O P
I ntr a o c ul ar  pr ess ur e
I P
I n v esti g ati o n al  pr o d u ct
I RB
I nstit uti o n al  R e vi e w  Bo ar d
I S O
I nt er n ati o n al  Or g a ni z ati o n f or  St a n d ar di z ati o n
L A S I K
L as er -assist e d i n sit u  k er a t o mile usis
L R I
Li m b al r el a xi n g i n cisi o n
M O P
M a n u al  of  pr o c e d ur es
N/ A
N ot  a p pli c a bl e
O D
Ri g ht  e y e
O S
L eft e y e
P C
P ost eri or  c a ps ul ot o m y
P C O
P ost eri or  c a ps ul ar  o p a cifi c ati o n
S A D E
S eri o us  a d v ers e  d e vi c e  eff e ct
S A E
S eri o us  a d v ers e  e v e nt
S D
St a n d ar d  d e vi ati o n
S O P
St a n d ar d  o p er ati n g  pr o c e d ur es
S SI
S e c o n d ar y  s ur gi c al i nt er v e nti o n
U D V A
U n c orr e ct e d  dist a n c e  vis u al  a c uit y
U N S V
U ns c h e d ul e d  visit
U S
U nit e d  St at es
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  1 0 of  5 4
A b b r e vi ati o n
D efi niti o n
U S A D E
U n a nti ci p at e d s eri o us  a d v ers e  d e vi c e  ef f e ct
V A
Vi s u al A c uit y
3 
P R O T O C O L   S U M M A RY
I n v esti g ati o n  T y p e
D e vi c e
St u d y  T y p e
I nt er v e nti o n al (S e e  Gl oss ar y   of  T er ms f or f ull  d efi niti o n)
I n v esti g ati o n al 
P r o d u ct
A C R Y S O F I Q  M o n of o c al  I ntr a o c ul ar  L e ns (I OL)
( M o d el S N 6 0 W F)
P u r p os e  a n d 
R ati o n al e
T h e  p ur p os e  of t his st u d y is t o  e v al u at e  w h et h er  a n  a ut o m at e d 
r efr a cti o n  d e vi c e  c a n  b e  us e d t o  p ers o n ali z e t h e  A- co nst a nt  as 
w ell  as st a n d ar d  r efr a cti o n (i e, t o  a  cli ni c ally i nsi g nifi c a nt 
dif f er e n c e). Err ors/ n ois e fr o m r efr a cti o n  pl a y s  a si g nifi c a nt r ol e, 
a n d it  w o ul d  b e i m p ort a nt t o  k n o w if  a n  a ut o m at e d  m et h o d  h as 
a n y   a d v a nt a g es  o v er  c o n v e nti o n al  m a nif est r efr a cti o n f or 
A- c o nst a nt  o pti mi z ati o n.
P ri m a r y  O bj e cti v e 
T o  d e m o nstr at e  e q ui v al e n c y ,  at  e a c h  of t h e  3  cli ni c al sit es, 
b et w e e n I O L  S R K/ T  A - co nst a nt  esti m at e d  b as e d  o n  p ost o p er ati v e
m a nif est s p h eri c al  e q ui v al e nt r efr a cti o n  at  3  m o nt hs  a n d I O L 
A- c o nst a nt  esti m at e d  b as e d  o n  p ost o p er ati v e s p h eri c al  e q ui v al e nt 
fr o m a ut or efr a cti o n usi n g  T o p c o n ® K R -1 W at  3  m o nt hs.
E n d p oi nt (s)  a n d 
ass ess m e nts  r el at e d 
t o  P ri m a r y 
O bj e cti v e(s)

A ut o m at e d  R efr a cti o n
 
A nt eri or  C h a m b er  D e pt h ( A C D)
 
K er at o m etr y
 
A xi al  L e n gt h ( A L)
 
M a nif est  R efr a cti o n
 
I OL P o w er (i m pl a nt e d)
 
W hit e -t o-W hit e  Dist a n c e
S e c o n d a r y 
O bj e cti v es 
N ot  A p pli c a bl e
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  1 1 of  5 4
E n d p oi nt(s)  a n d 
Ass ess m e nts  R el at e d 
t o  S e c o n d a r y 
O bj e cti v e(s)
N ot  A p pli c a bl e
S af et y  E n d p oi nts 
a n d  A ss ess m e nts 

A d v ers e  E v e nt ( A E) rat es  of  A C R Y S O F I Q  M o n of o c al 
I OL ( M o d el  S N 6 0 W F) a n d  us e  of t h e  T o p c o n  K R- 1 W 
will  b e  c oll e ct e d s e p ar at el y
 
I ntr a o c ul ar  Pr ess ur e (I O P)
 
Slit -L a m p  E x a mi n ati o n
 
Dil at e d  F u n d us  E x a mi n ati o n
 
I OL  O bs er v ati o ns
 
S u bj e cti v e  P ost eri or  C a ps ul ar  O p a cifi c ati o n ( P C O)
Ass ess m e nt
 
P ost eri or  C a ps ul ot o m y ( P C)
 
S u r gi c al  Pr o bl e ms
 
Ot h er  Pr o c e d ur es  at  S ur g er y
 
A Es
 
S e c o n d ar y   S ur gi c al I nt er v e nti o ns ( S SIs)
 
D e vi c e  D efi ci e n ci es
St u d y  D esi g n
Pr os p e cti v e ;  o bs er v er-m as k e d  (e x a mi n er  p erf or mi n g  m a nif est 
r efr a cti o n is m as k e d t o t h e r efr a cti v e t ar g et  a n d r efr a cti v e  err or 
fr o m t h e s ur gi c al  pl a n ni n g  a n d t h e  o p er ati v e  visit ); n o n-
r a n d o mi z e d; t ot al  d ur ati o n  of  a s u bj e ct’s  p arti ci p ati o n i n t h e st u d y
is a p pr o xi m at el y  4. 5  m o nt hs.
S u bj e ct  P o p ul ati o n
A d ults ( 2 2  y e ars  a n d  ol d er)  wit h  c at ar a ct i n  o n e or  b ot h  e y es 
r e q uiri n g s ur g er y  wit h i m pl a nt ati o n  of  a  m o n of o c al I OL.
K e y I n cl usi o n 
C rit e ri a
( S e e S e cti o n  9. 1)

Pl a n n e d  c at ar a ct r e m o v al  b y  p h a c o e m ulsifi c ati o n  wit h 
i m pl a nt ati o n  of  a  m o n of o c al I O L
 
Pr e o p er ati v e  k er at o m etri c  asti g m atis m  ≤ 1. 0   D
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  1 2 of  5 4
K e y  E x cl usi o n
C rit e ri a
(S e e  S e cti o n  9. 2)

Hist or y   of  a nt eri or s e g m e nt ( c or n e al,  a nt eri or  c h a m b er, 
s ul c us)  or  p ost eri or s e g m e nt ( u v e al,  vitr e o -r eti n al)  p at h ol o g y
 
Hist or y   of r e c urr e nt  a nt eri or s e g m e nt / p ost eri or s e g m e nt 
i nfl a m m ati o n
 
Cli ni c all y  si g nifi c a nt, i n t h e  o pi ni o n  of t h e In v esti g at or,  a n y
c or n e al  d ys tr o p hy  or  a n y   ot h er  c or n e al  a b n or m alit y/ p at h ol o g y
 
Cli ni c all y  si gnifi c a nt , i n t h e  o pi ni o n  of t h e In v esti g at or, 
s e v er e  dr y  e ye
 
Di a g n osis of  a m bl y o pi a
 
S y st e mi c  m e di c ati o ns t h at, i n t h e  o pi ni o n  of t h e  In v est i g at or, 
m a y   c o nf o u n d t h e  o ut c o m e  or i n cr e as e t h e ris k of 
c o m pli c ati o ns  t o t h e s u bj e ct  or  ot h er  m e di c ati o ns i n cl u di n g 
a nti c h oli n er gi cs,  al p h a  a dr e n er gi c  bl o c ki n g  a g e nts  wit h 
si mil ar si d e  eff e cts 
D at a  A n al ysis  a n d 
S a m pl e  Si z e 
J ustifi c ati o n
D at a  A n al ysis: T h e  pri m ar y   a n alys is s et f or  eff e cti v e n ess 
a n al ys es  will  b e t h e All- I m pl a nt e d A n al ys is  S et. T his  i n cl u d es  all 
e y es  wit h s u c c essf ul I O L  i m pl a nt ati o n. A n al y sis  b as e d  o n t h e 
st u d y e y e  will  b e  c o nsi d er e d  pri m ar y. A d diti o n al s u p p orti v e 
a n al ys es  m a y   b e  c o n d u ct e d u si n g t h e  B est -C as e  A n al y sis  S et. 
T his  i n cl u d es  all  e yes s u c c essf ull y  i m pl a nt e d  wit h t h e I O L t h at 
h a d
 
at l e ast  1  p ost o p er ati v e  visit;
 
n o  m a c ul ar  d e g e n er ati o n  at  a n y  ti m e;  a n d
 
n o  m aj or  pr ot o c ol  vi ol ati o n
T h e  S af et y  A n al ys is  S et  will i n cl u d e  all  e yes  wit h  att e m pt e d I O L  
i m pl a nt ati o n (s u c c essf ul  or  a b ort e d  aft er  c o nt a ct  wit h t h e  e ye)  T h e 
S af et y   An al y sis  S et  will  b e  us e d f or t h e s af et y   a n al ys es. If t h e 
2- si d e d  9 0 %  c o nfi d e n c e i nt er v als f or t h e  m e a n  diff er e n c e i n I O L 
A- c o nst a nts is  c o nt ai n e d  wit hi n (- 0. 1 5,  0. 1 5), t h e n  e q ui v al e n c e 
will  b e  c o n cl u d e d.  D es cri pti v e st atisti cs ( m e a n,  m e di a n, st a n d ar d 
d e vi ati o n,  n u m b er  of s u bj e cts/ e y es,  mi ni m u m,  m a xi m u m,  a n d 
(t w o-si d e d)  9 0 %  c o nfi d e n c e i nt er v al)  will  b e  pr o vi d e d f or 
eff e cti v e n ess  e n d p oi nts.
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  1 3 of  5 4
D es cri pti v e st atisti cs f or  A Es will  b e  pr es e nt e d s e p ar at el y.
S a m pl e  Si z e  J ustifi c ati o n: A  mi ni m u m  of  1 6 5 s u bj e cts  will  b e 
e nr oll e d t o  e ns ur e  at l e ast  1 4 4  e v al u a bl e s u bj e cts ( 4 8  e v al u a bl e 
s u bj e cts  p er sit e)  c o m pl et e t h e st u d y.
Wi t h  4 8  e v al u a bl e s u bj e cts  p er sit e, st u d y  h as  9 0 %  c h a n c e t o
s h o w t h at t h e  m e a n  diff er e n c e i n I O L  A-c o nst a nts  c al c ul at e d  wit h 
 
p ost - o p  m a nif est s p h eri c al  e q ui v al e nt r efr a cti o n  at 
3 m o nt hs  vs.
 
p ost -o p s p h eri c al  e q ui v al e nt fr o m  a ut or efr a cti o n usi n g 
T o p c o n K R -1 W at  3  m o nt hs
is  wit hi n t h e  e q ui v al e n c e  m ar gi n  of ± 0. 1 5 f o r  e a c h sit e  ass u mi n g 
t h at t h e  m e a n  a n d t h e st a n d ar d  d e vi ati o n  of  a  p air e d  diff er e n c e  ar e 
0  a n d  0. 3 5 r es p e cti v el y . 
St a n d ar d  d e vi ati o n of  0. 3 5 is  b as e d  o n t h e st a n d ar d  d e vi ati o n of 
t h e  diff er e n c e i n  A-c o nst a nt  b et w e e n t h e first  a n d t h e s e c o n d  e y e 
i n s u bj e cts i m pl a nt e d  wit h A C R Y S O F I Q  M o n of o c al I O L   
 
 ( A C R Y S O F I Q  R e S T O R® M ultif o c al  + 2. 5 D).
K e y  W o r ds f o r 
P osti n g i n  R e gist ri es
Pr os p e cti v e , int er v e nti o n al,  m ulti - ce nt er st u d y; b ei n g  c o n d u ct e d 
i n t h e  U S  a n d Ir el a n d; 1 8 3  e nr oll e d  1 4 4  c o m pl et e d  su bj e cts
4 
P R O T O C O L   AM E N D M E N T S
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
M o difi c ati o n  of t h e  pr ot o c ol is  pr o hi bit e d  wit h o ut  pri or  writt e n  a gr e e m e nt i n t h e f or m  of  a 
pr ot o c ol  a m e n d m e nt.  All  a m e n d m e nts  m ust b e  cr e at e d  b y t h e  St u d y   S p o ns or a n d  m ust  b e 
a p pr o v e d  b y t h e a n I n d e p e n d e nt  Et hi cs  C o m mitt e e (I E C )/ I nstit uti o n al  R e vi e w  B o ar d (I RB)
pri or t o i m pl e m e nt ati o n  e x c e pt  w h e n r e q uir e d t o  miti g at e i m m e di at e s af et y ris ks  or  w h e n t h e 
c h a n g es i n v ol v e  o nl y l o gisti c al  or  a d mi nistr ati v e r e visi o ns. 

P a g e  1 5 of  5 4
6 
I N T R O D U C TI O N
6. 1 
R ati o n al e  a n d  B a c k g r o u n d
F oll o wi n g  c at ar a ct s ur g er y , t h er e is  a  distri b uti o n i n r efr a cti v e o ut c o m es r el ati v e t o t h e 
i nt e n d e d r efr a cti v e t ar g et (t y pi c all y  e m m etr o pi a).  T h e r efr a cti v e o ut c o m e  distri b uti o n  will 
h a v e  a  m e a n  offs et (r el ati v e t o t ar g et)  as  w ell  as s o m e fi nit e s pr e a d ( e g, st a n d ar d  d e vi ati o n). 
Pr e vi o usl y   w e  h a v e  a n al yz e d t h e s pr e a d i n  o ut c o m es (f or st a n d ar d - of-c ar e s ur g er y)  u si n g  a n 
“ err or  b u d g et ”  a n al ys is.  T his  a n al ysis  pr o vi d es t h e f oll o wi n g  esti m at e d f or r efr a cti v e 
o ut c o m e  v ari a n c e (i e, t h e s q u ar e  of t h e st a n d ar d  d e vi ati o n i n s p h eri c al  e q ui v al e nt  err or):
 
P ost o p er ati v e r efr a cti o n  – 2 5. 6 %
 
I OL  pl a c e m e nt ( a xi al  p ositi o n,  d e c e ntr ati o n, tilt)  – 1 6. 8 %
 
C or n e a  a nt eri or  as p h eri cit y   – 1 6. 8 %
 
C or n e a  p ost eri or/ a nt er i or r a di us r ati o – 1 1 . 4 %
 
C or n e al  a nt eri or r a di us  m e as ur e m e nt  – 9. 8 %
 
I OL  st e p si z e – 5. 8 %
 
C or n e a r efr a cti v e i n d e x  – 4. 7 %
 
A xi al l e n gt h  m e as ur e m e nt  – 3. 7 %
 
I OL  m a n uf a ct uri n g  t ol er a n c e – 2. 1 %
 
Vi tr e o us r efr a cti v e i n d e x – 2. 1 %
 
A q u e o us r efr a cti v e i n d e x  – 0. 9 %
 
C or n e a  p ost eri or  as p h eri cit y   – 0. 2 %
 
C or n e a t hi c k n ess  – 0. 1 %
T h e r es ults fr o m t h e  a n al y sis s h o w t h at:
 
N ois e i n t h e  p ost o p er ati v e r efr a cti o n is  a  m aj or  c o ntri b ut or
 
U n c ert ai nt y  i n t h e I O L l o c ati o n i n t h e  e ye is  als o  a l ar g e  c o m p o n e nt

A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
M ost  of t h e r e m ai ni n g  c o ntri b ut ors r el at e t o i n a d e q u at e  pr e o p er ati v e  c h ar a ct eri z ati o n 
of t h e  e y e
C o n v e nti o n al  cli ni c al  wis d o m  h ol ds t h at  e a c h s ur g e o n  will  h a v e  u ni q u e  o ut c o m es  d u e t o 
f a ct ors  p arti c ular t o  t h eir s urgi c al t e c h ni q u e, i n h er e nt  cli ni c m e as ur e m e nt  pr a cti c es  a n d 
e q ui p m e nt .  T h e  g e n er al  c o n c e pt is t h at s ur gi c al t e c h ni q u e a n d i n s o m e i nst a n c es 

P a g e  1 6 of  5 4
c o m pli c ati o ns   will i m p a ct t h e fi n al r esti n g l o c ati o n  of t h e I O L.  Ot h er sit e- s p e cifi c f a ct ors 
s u c h  as  bi o metr y   d e vi c e  c ali br ati o n  or  p osto p er ati v e r efr a cti o n  pr o c e d ur e s p e cifi cs  c o ul d  als o 
i nfl u e n c e t h e  offs et.  S ur g e o ns  ar e  e n c o ur a g e d t o tr a c k  o ut c o m es  a n d  mi ni mi z e t h e  offs et  by 
“ p ers o n ali zi n g ” t h e I O L   p o w er  e q u ati o n  c o nst a nt(s) r el at e d t o t h e I O L  p ositi o n ( eg, t h e 
“ A- c o nst a nt ”) (G al e 2 0 0 9) .  T his r e q uir es  a n aly z i n g  pr eo p er ati v e bi o m etr y , i m pl a nt e d l e ns 
p o w er ,  a n d p ost o p er ati v e r efr a cti o n (ty pi c all y  c oll e ct e d fr o m  m a nif est r efr a cti o n) f or  a 
p o p ul ati o n  of  5 0 +  e y es  p er I O L  m o d el ( S h e ar d  2 0 1 4).  C h a n g es i n t h e A- c o nst a nt  of  0. 1 5 D  or 
l ess  ar e  n ot  c o nsi d er e d  cli ni c all y si g nifi c a nt,  b as e d  o n t h e i m p a ct  o n r efr a cti v e  o ut c o m e 
distri b uti o ns ( Arist o d e m o u  2 0 11).
6. 2 
P u r p os e  of t h e  St u d y
T h e  p ur p os e  of  t his st u d y is t o  e v al u at e  w h et h er  a n  a ut o m at e d r efr a cti o n  d e vi c e  c a n  b e  u s e d 
t o  p ers o n ali z e t h e A- c o nst a nt  as  w ell  as st a n d ar d r efr a cti o n (i e, t o  a  cli ni c all y  i nsi g nifi c a nt 
dif f er e n c e).  Err ors/ n ois e fr o m r efr a cti o n  pl a ys  a si g nifi c a nt r ol e,  a n d it  w o ul d  b e i m p ort a nt t o 
k n o w if  a n  a ut o m at e d  m et h o d  h as  a n y  a d v a nt a g es  o v er  c o n v e nt i o n al  m a nif est r efr a cti o n f or 
A- c o nst a nt  o pti mi z ati o n.
6. 3 
Ris k s  a n d  B e n efits
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
T h e I O L  b ei n g  us e d i n t his st u d y  is  a  U S  F o o d  a n d  Dr u g  A d mi nistr ati o n (F D A )-a p pr o v e d 
A C R Y S O F I Q  M o n of o c al I OL  ( M o d el  S N 6 0 W F).  C urr e ntl y, t his I O L r e pr es e nts t h e i n d ustr y 
st a n d ar d  of c ar e f or  p ati e nts w h o  d e v el o p  c at ar a ct  a n d r e q uir e  c at ar a ct s ur g er y  wit h  a 
m o n of o c al I O L  i m pl a nt ati o n. T his I O L   h as  b e e n  w ell st u di e d i n  pr e vi o us  Al c o n  cli ni c al 
st u di es a n d t h e s af et y  a n d  ef f e cti v e n ess  of t his I O L  h as  b e e n  w ell d o c u m e nt e d  a n d 
est a blis h e d.
H o w e v er , th er e  m a y   als o  b e pr e vi o usl y  u ni d e ntifi e d ris ks wit h us e  of  t h e  M o d el  S N 6 0 W F 
I OL. A n y f or es e e a bl e ris k t o s u bj e cts i n t his  cli ni c al st u d y  will  b e  mi ni mi z e d  b y  c o m pli a n c e 
wit h t h e  eli gi bilit y   crit eri a, st u d y  pr o c e d ur es, a n d  cli ni c al  m o nit ori n g . R ef er t o t h e  Dir e cti o ns 
f or  Us e (D F U ) f or  a d diti o n al i nf or m ati o n.
T h e  T o p c o n K R -1 W  W a v e -Fr o nt  A n al y z er  d e vi c e  us e d t o  o bt ai n  a ut or efr a cti o n  d at a is  a  n o n -
si g nifi c a nt ris k  d e vi c e.  T h er e is  n o  dir e ct  cli ni c al  b e n efit t o t h e s u bj e ct’s  p arti ci p ati o n i n t his 
st u d y. 
All  ot h er t est  pr o c e d ur es i n t his st u d y   ar e st a n d ar d  cli ni c al  m e as ur e me nts f or  pr e- o p er ati v e 
a n d  p ost -o p er ati v e  c at ar a ct s ur g er y; t h er ef or e t h er e  ar e  v er y li mit e d  n o n -si g nifi c a nt ris ks t o 
t h e s u bj e ct t h at  c o ul d  e m a n at e fr o m t h es e st u dy  ass ess m e nts.

P a g e  1 7 of  5 4
All  d e vi c es  us e d i n t his st u d y  t o  c o m pl et e  ass ess m e nts  ar e  F D A  a p pr o v e d  a n d  will  b e  us e d 
a c c or di n g t o t h e  m a n uf a ct ur er ’s i nstr u cti o ns.
7 
S T U D Y O B J E C TI V E S
7. 1 
P ri m a r y  O bj e cti v e
T o   d e m o nstr at e e q ui v al e n c y 1, at  e a c h  of t h e  3  cli ni c al sit es,  b et w e e n I O L   S R K/ T A- c o nst a nt
esti m at e d  b as e d  o n  p ost o p er ati v e m a nif est s p h eri c al  e q ui v al e nt r efr a cti o n  at  3  m o nt hs  a n d 
I OL  A - co nst a nt  esti m at e d  b as e d  o n  p ost o p er ati v e s p h eri c al  e q ui v al e nt fr o m a ut or efr a cti o n 
usi n g  T o p c o n K R -1 W at  3  m o nt hs 2.

1 A  m ar gi n  of  ± 0. 1 5 is  c h os e n  b as e d  o n  a n i n d e p e n d e nt  e xt er n al i n v esti g ati o n t h at 
h as  est a blis h e d  0. 1 5  D  as t h e t hr es h ol d f or  cli ni c al si g nifi c a n c e i n t h e  A -c o nst a nt 
(Arist o d e m o u  2 0 1 1).

2 T h e  3- m o nt h p ost o p er ati v e  visit  h as  b e e n  est a blis h e d  as t h e  p oi nt  of r efr a cti v e 
st a bilit y i n  m ulti pl e  pri or  cli ni c al st u di es.
7. 1. 1 
P ri m a r y  Eff e cti v e n ess  E n d p oi nts
 
I OL  A - co nst a nts  esti m at e d  b as e d  o n  pr e o p er ati v e  bi o m etr y , I O L  p o w er  a n d 
p ost o p er ati v e  m a nif est s p h eri c al  e q ui v al e nt r efr a cti o n  at  3  m o nt hs.
 
I OL  A - co nst a nt  esti m at e d  b as e d  o n  pr e o p er ati v e  bi o m etr y , I O L  p o w er  a n d 
p ost o p er a ti v e s p h eri cal  e q ui v al e nt fr o m  a ut or efr a cti o n usi n g  T o p c o n K R - 1 W at 
3 m o nt hs .
7. 1. 2 
P ri m a r y  Eff e cti v e n ess  Ass ess m e nts
 
A ut or efr a cti o n  usi n g  T o p c o n K R -1 W
 
A C D
 
A L
 
W hit e -t o-W hit e  Dist a n c e
 
K er at o m etr y
 
M a nif est  R efr a cti o n

A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
I OL  P o w er  I m pl a nt e d

P a g e  1 8 of  5 4
7. 2

 
 

 

 
7. 3 
S af et y  O bj e cti v e
 
A E r at es f or A C R Y S O F I Q  M o n of o c al I O L  ( M o d el  S N 6 0 W F) a n d  us e  of  To p c o n 
K R -1 W  will  b e  c oll e ct e d s e p ar at el y
7. 3. 1 
S af et y  E n d p oi nt
 
M o nit or  A Es  r el at e d t o t h e I O L  a nd st u d y   ass ess m e nts  at  all  p osto p er ati v e  visits
7. 3. 2 
A d diti o n al  S af et y  Ass ess m e nts
 
I O P
 
Slit -L a m p  E x a mi n ati o n
 
Dil at e d  F u n d us  E x a mi n ati o n
 
I OL  O bs er v ati o ns
 
S u bj e cti v e  P C O  Ass ess m e nt
 
P C
 
S ur gi c al  Pr o bl e ms
 
Ot h er  Pr o c e d ur es  at  S ur g er y
 
A Es (i n cl u di n g S SI s)

A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
D e vi c e  D efi ci e n ci es

P a g e  2 0 of  5 4
A t ot al  of  4  s c h e d ul e d visits  ar e  pl a n n e d i n cl u di n g t h e  S cr e e ni n g/ V isit  0 a n d t h e  O p er ati v e 
V isit/ Visit  0 0.  S c h e d ul e d  p osto p er ati v e  visits  m ust o c c ur  at t h e f oll o wi n g i nt er v als: 
2 0- 4 0 d a y s, a n d  8 0- 1 0 0 d a y s. S e e  Ta bl e  8- 1  S c h e d ul e  of  St u d y   Visits.
T a bl e 8 – 1
S c h e d ul e  of  St u d y  Vi sits
Ti m e F r o m I m pl a n t atio n
St u d y  V isit
S cr e e ni n g /  Pr e o p er ati v e ( D a y -2 8 t o  D a y   0) 
Vi sit  0
O p er ati v e ( D a y  0)
Vi sit  0 0
2 0- 4 0 d a y s
Vi sit 1
8 0- 1 0 0 d a y s
Vi sit 2
8. 2 
R ati o n al e f o r  St u d y  D esi g n
T his st u d y  will  n ot b e  e v al u ati n g  a n i n v esti g ati o n al  pr o d u ct (I P). It is  a st u d y i nt e n d e d t o 
e v al u at e  c urr e nt  a v ail a bl e ass ess m e nts ( a ut o m at e d  vs .   m a n u al)  wit h  w hi c h  m a nif est 
r efr a cti o n  d at a is  o bt ai n e d t o  u n d erst a n d, if  d at a fr o m  a n  a ut o m at e d r efr a ct or  c a n  b e  utili z e d 
t o  o pti mi z e t h e A- c o nst a nt  as  w ell  as  m a n u al s u bj e cti v e r efr a cti o n ( i e, t o  a  cli ni c all y 
i nsi g nifi c a nt  diff er e n c e).  T h us, t h e  eff e cti v e n ess  a n al ys es  will  b e  c o n d u ct e d  o n si n gl e  e y e 
o ut c o m es  a n d f or t his r e as o n  o nl y   on e  e y e (s ur g e o n  d et er mi n ati o n)  will  b e  p art  of  a n d 
f oll o w e d t hr o u g h t h e  e ntir e st u d y. At  e a c h  of t h e  3 sit es, t h e  e x a mi n er  p erf or mi n g t h e 
m a nif est r efr a cti o n  at t h e  p ost o p er ati v e f oll o w -u p  visits  will  b e  m as k e d t o t h e r efr a cti v e 
t ar g et  a n d r efr a cti v e  err or fr o m t h e s ur gi c al  pl a n ni n g  a n d t h e  o p er ati v e  visit.
8. 3 
R ati o n al e f o r  d u r ati o n  of t r e at m e nt/f oll o w -u p
T h e i m pl a nt ati o n  a n d  us e  of t h e  m ar k et e d  M o d el  S N 6 0 W F I O L  is i n  a c c or d a n c e  wit h t h e 
D F U f or t his I O L.
8. 4 
D at a  M o nit o ri n g  C o m mitt e e
N ot  A p pli c a bl e
8. 5 
P u r p os e  a n d  Ti mi n g  of I nt e ri m  A n al ys es  a n d  R es ulti n g  D esi g n 
A d a pt ati o ns
N ot  A p pli c a bl e
9 
S U B J E C T  P O P U L A TI O N
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
T h e st u d y   p o p ul ati o n  c o nsists  of m al e  a n d f e m al e s u bj e cts  2 2  y e ars  a n d  ol d er wit h  a 
di a g n osis  of  c at ar a ct i n  o n e  or  b ot h  e y es r e q uiri n g s ur g er y   wit h i m pl a nt ati o n  of  a  m o n of o c al 
I OL  i n t h e  c a ps ul ar  b a g. O nl y   o n e  e ye  will  b e  e nr oll e d i n t h e st u d y   p er s ur g e o n 
d et er mi n ati o n.  If  b ot h  e y es  ar e  eli gi bl e t h e n t h e  e y e  u n d er g oi n g s ur g er y first s h o ul d  b e 

P a g e  2 1 of  5 4
e nr oll e d ( as  p er  Fi g ur e  8 -1). A p pr o xi m at el y   3  c e nt ers  w orl d wi d e  will  p arti ci p at e i n t his st u d y 
wit h  a t ar g et  of  a p pr o xi m at el y  5 5 s u bj e cts  p er sit e.  Sit e s p e cifi c t ar g ets  m a y  b e  a dj ust e d 
b as e d  o n i n di vi d u al sit e  c a p a biliti es.  E nr oll m e nt  pr oj e cti o ns  ar e  as f oll o ws:
 
1 8 3 s u bj e cts  ar e  e x p e ct e d t o  b e  e nr oll e d ( 1 0 % s cr e e n f ail ur e r at e is  e x p e ct e d)
 
1 6 5  eli gi bl e  s u bj e cts t h at  m e et i n cl usi o n/ e x cl usi o n  crit eri a ( 1 3 %  dis c o nti n u ati o n r at e)
 
1 4 4 s u bj e cts t o s u c c essf ull y   c o m pl et e t h e fi n al stu d y   visit ( Visit  3)
N O T E : If  o n e  or  b ot h  e y es  h a v e c at ar a cts,  o nl y t h e  e y e  b ei n g  ass ess e d  will  n e e d t o  m e et t h e 
i n cl usi o n  a n d  e x cl usi o n  crit eri a.
9. 1 
I n cl usi o n  C rit e ri a
S u bj e cts  eli gi bl e f or i n cl usi o n i n t his st u d y   m ust f ulfill all  of t h e f oll o wi n g  crit eri a:
1. S u bj e ct  m ust  b e  a bl e t o  u n d erst a n d  a n d  si g n  a n  I EC/ I RB  a p pr o v e d  I CF
2. Wi lli n g  a n d  a bl e t o  att e n d  all s c h e d ul e d st u dy  visits  as r e q uir e d  p er  pr ot o c ol
3. A d ults ( 2 2  y e ars  or  ol d er  at t h e ti m e  of  e nr oll m e nt i n t h e st u d y)  di a g n os e d  wit h 
c at ar a ct i n  o n e  or  b ot h  e y es
4. Pl a n n e d  c at ar a ct r e m o v al  b y   p h a c o e m ulsifi c ati o n  wit h i m pl a nt ati o n  of  a  m o n of o c al 
I OL;  l as er r efr a cti v e  pr o c e d ur es f or i n cisi o ns ( pri m ar y a n d si d e p ort), c a ps ul o r h e xis 
a n d l e ns fr a g m e nt ati o n  ar e  all o w e d
5. Pr e o p er ati v e  k er at o m etri c  asti g m atis m  ≤ 1. 0   D
9. 2 
E x cl usi o n  C rit e ri a
S u bj e cts f ulfilli n g  a n y
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
of t h e f oll o wi n g  crit eri a  ar e  n ot  eli gi bl e f or i n cl usi o n i n t his st u d y :
1. W o m e n  of  c hil d b e ari n g  p ot e nti al,  d efi n e d  as  all  w o m e n  w h o  ar e  p h ys i ol o gi c all y 
c a p a bl e  of  b e c o mi n g  pr e g n a nt  a n d  w h o  ar e  n ot  p ost m e n o p a us al f or  at l e ast  1  y e ar  or 
ar e l ess t h a n  6  w e e ks  si n c e st erili z ati o n,  ar e  e x cl u d e d fr o m  p arti ci p ati o n if  a n y   of t h e 
f oll o wi n g  a p ply:
a. t h e y  ar e  c urr e ntl y  pr e g n a nt
b. h a v e  a  p ositi v e  uri n e  pr e g n a n c y  t est r es ult at  S cr e e ni n g / Visit  0
c. i nt e n d t o  b e c o m e  pre g n a nt  d uri n g t h e st u d y   p eri o d
d. ar e  br e ast -f e e di n g

P a g e  2 2 of  5 4
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
2. Hist or y   of a n y  c o n diti o n  wit h  ass o ci at e d fl u ct u ati o n  of  h or m o n es t h at  c o ul d l e a d t o 
r efr a cti v e  c h a n g es
3. Hist or y   of  a nt eri or s e g m e nt ( c or n e al,  a nt eri or  c h a m b er, s ul c us)  or  p ost eri or s e g m e nt 
( u v e al,  vitr e o-r eti n al)  p at h ol o g y i n cl u di n g r eti n al  v as c ul ar  o c cl usi v e  dis e as e, r eti n al 
d et a c h m e nt  or  p eri p h er al r eti n al l as er  p h ot o c o a g ul ati o n,  a g e -r el at e d  m a c ul ar 
d e g e n er ati o n ( A M D ),  gl a u c o m a,  di a b eti c r eti n o p at h y, r eti nitis  pi g m e nt os a  a n d  a n y 
o pti c  n er v e  p at h ol o g y
4. Hist or y   of r e c urr e nt  a nt eri or s e g m e nt / p ost eri or s e g m e nt i nfl a m m ati o n
5. Cli ni c all y  si g nifi c a nt, i n t h e  o pi ni o n  of t h e I n v esti g at or,  a n y  c or n e al  dys tr o p h y  or  a n y 
ot h er  c or n e al  a b n or m alit y/ p at h ol o g y  ( e pit h eli al, str o m al  or  e n d ot h eli al) i n cl u di n g  b ut 
n ot li mit e d t o t h e f oll o wi n g:  k er atitis,  k er at o c o nj u n cti vitis  a n d  k er at o u v ei tis
6. Cli ni c all y  si g nifi c a nt, i n t h e  o pi ni o n  of th e  I n v esti g at or, s e v er e  dr y  e ye
7. Hist or y   of  pr e vi o us i ntr a o c ul ar  or  c or n e al s ur g er y
8. Di a g n osis of  a m bl y o pi a
9. S y st e mi c  m e di c ati o ns t h at, i n t h e  o pi ni o n  of t h e  I n v esti g at or,  m a y  c o nf o u n d t h e 
o ut c o m e  or i n cr e as e t h e ris k of  c o m pli c ati o ns t o t h e s u bj e ct (e g, Ta m us oli n 
H y dr o c hl ori d e  – Fl o m a x)  or  ot h er  m e di c ati o ns i n cl u di n g  a nti c h oli n er gi cs,  al p h a 
a dr e n er gi c  bl o c ki n g  a g e nts  wit h si mil ar si d e  ef f e cts (e g, s mall  p u pil/fl o p p y  iris 
s yn dr o m e)
1 0. C o n c urr e nt  p arti ci p ati o n i n  a n ot h er  cli ni c al  st u d y t h at, i n t h e In v esti g at or ’s  o pi ni o n, 
m a y   c o nf o u n d th e r es ults  of t h e  c urr e nt st u d y
1 1. A n y   ot h er  o c ul ar  or sys t e mi c  c o-m or bi dit y  t h at, i n t h e  o pi ni o n  of t h e I n v esti g at or, 
m a y   c o nf o u n d t h e r es ults  of t his st u d y or  pr o hi bit t h e  c o m pl eti o n  of t h e st u d y  
ass ess m e nts  or i n cr e as e t h e ris k f or t h e s u bj e ct
1 2. S u bj e cts  wit h  c o n diti o ns t h at i n cr e as e t h e ris k  of  z o n ul ar r u pt ur e  d uri n g  c at ar a ct 
e xtr a cti o n  pr o c e d ur e t h at  m a y   aff e ct t h e  p ost o p er ati v e c e ntr ati o n  or tilt  of t h e l e ns
1 3. A n y   ot h er  pl a n n e d  o c ul ar s urgi c al  pr o c e d ur es i n cl u di n g  b ut  n ot li mit e d t o  li m b al 
r el a xi n g i n cisi o n (L R I)/ Asti g m ati c  K er at ot o m y  a n d l as er-assist e d i n sit u 
k er at o mil e usis ( L A SI K)

P a g e  2 3 of  5 4
9. 3 
E x cl usi o n  C rit e ri a  at  Ti m e  of  S u r g e r y
1. S ur gi c al  c o m pli c ati o ns i n cl u di n g  b ut  n ot li mit e d t o l oss  of  z o n ul ar i nt e grit y/ z o n ul ar 
w e a k n ess,  z o n ul ar r u pt ur e,  a nt eri or  or  p ost eri or  c a ps ul e r u pt ur e,  a n y  e vi d e n c e  of fl ui d 
mis dir e cti o n  d uri n g t h e  c at ar a ct  pr o c e d ur e  wit h  pr o gr essi v e s h all o wi n g  of t h e  a nt eri or 
c h a m b er ,  u n c o ntr oll a bl e I O P
2. M e c h a ni c al  or  sur gi c al  m a ni p ul ati o n  of t h e  p u pil
3. E x c essi v e iris  m o bilit y
4. I na bilit y  t o  pl a c e t h e I O L i n t h e  c a ps ul ar  b a g d u e t o s ur gi c al  c o m pli c ati o ns
N O T E: S u bj e cts  w h o s atisf y   a ny  of t h e  E x cl usi o n  Crit eri a  at t h e  T i m e  of  S ur g er y  n ot e d 
i n  S e cti o n 9 . 3  will  b e f oll o w e d f or s af ety if t h e y  ar e i m pl a nt e d  or t h e I O L t o u c h es t h e 
e y e ;  a n d  d at a fr o m t h es e s u bj e cts  will  n ot  b e  p art  of t h e  eff e cti v e n ess  d at a s et.
9. 4 
R es c r e e ni n g  of  S u bj e cts
R es cr e e ni n g  of s u bj e cts is  n ot  all o w e d i n t his st u d y.
1 0 
T R E A T M E N T
T hr o u g h o ut t h e  cli ni c al st u d y , t h e I n v esti g at or is r es p o nsi bl e f or t h e  a c c o u nti n g  of  all I P a n d 
m ust  e ns ur e t h at t h e  cli ni c al st u d y  pr o d u ct is  us e d i n  a c c or d a n c e  wit h t h e  m a n uf a ct ur er ’s 
D F U.
Sit e t e m p er at ur e  m o nit ori n g  of I O Ls is  n ot r e q uir e d. 
1 0. 1 
I n v esti g ati o n al  P ro d u ct
T a bl e 1 0 – 1 
Te st A rti cl e
Te st  Pr o d u ct 
A C R Y S O F I Q M o n of o c al  I O L ( M od el  S N 6 0 W F)
M a n uf a ct ur er 
Al c o n
I n di c ati o n f or  us e 
I m pl a nt ati o n f or  vis u al  c orr e cti o n  of  a p h a ki a s e c o n d ar y t o r e m o v al 
o f  a  c at ar a ct o us l e ns i n s u bj e cts  wit h  a n d  wit h o ut  pr es by o pi a,  w h o 
d esir e  dist a n c e  visi o n. 
I nt e n d e d  P ur p os e i n 
t h e  c urr e nt st u d y
I m pl a nt ati o n f or  vis u al  c orr e cti o n  of  a p h a ki a s e c o n d ar y t o r e m o v al 
of  a  c at ar a ct o us l e ns i n s u bj e cts  wit h  a n d  wit h o ut  pr es b y o p i a,  w h o 
d esir e  dist a n c e  visi o n.
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  2 4 of  5 4
Pr o d u ct  d es cri pti o n 
a n d  p ar a m et ers 
a v ail a bl e f or t his 
st u d y
O pti c  T y p e:   Bi c o n v e x T o ri c   As p he ri c O pti c
O pti cs  M at eri al : Ultr a vi ol et  a n d  bl u e li g ht filt eri n g A c r yl at e/ 
M et h a cr yl ate  C o p ol y m er
O pti c  P o w ers : 6. 0- 3 4. 0  D i n  0. 5 0  D st e ps
I n d e x  of  R efr a cti o n:  1. 5 5
H a pti c  C o nfi g ur ati o n : S T A B L E F O R C E ® H a pt i cs
H a pti c  M at eri al : Ultr a vi ol et  a n d  bl u e li g ht filt eri n g A c r yl at e
M et h a cr yl ate  C o p ol y m er ( B o ett n er  1 9 6 2)
O pti c  Di a m et er ( m m) : 6. 0
O v er all  L e n gt h ( m m):  1 3. 0
H a pti c  A n gl e: 0°
F or m ul ati o n 
N/ A
Us a g e
I OLs ar e i m pl a nt a bl e  m e di c al  d e vi c es  a n d  ar e i nt e n d e d f or l o n g -
t er m  us e  o v er t h e lif eti m e  of t h e ps e u d o p h a ki c  s u bj e ct.
N u m b er/ A m o u nt  of
Pr o d u ct t o  b e 
Pr o vi d e d t o t h e 
S u bj e ct
T h e I n v esti g at or is t o  k e e p  a  c urr e nt r e c or d  of t h e  dis p e nsi n g  of  all 
pr o d u ct s.  T his r e c or d  will  b e  m a d e  a v ail a bl e t o t h e  S p o ns or’s 
m o nit or t o  a c c o u nt f or  all  pr o d u ct s. A n y  dis cr e p a n c y  a n d/ or 
d efi ci e n c y   m ust  b e r e c or d e d,  wit h  a n  e x pl a n ati o n.
P a c k a gi n g 
d es cri pti o n
E a c h I O L  will  b e i n di vi d u all y   p a c k a g e d a n d  will  h a v e  a  u ni q u e 
s eri al  n u m b er.  T h e I OL  p a c k a g e  will  c o nt ai n t h e f oll o wi n g it e ms:
 
T h e I O L
 
A s u bj e ct r e gistr ati o n  c ar d ( L e ns I m pl a nt  C ar d)
 
A s u bj e ct i d e ntifi c ati o n  c ar d
 
A d h esi v e l a b els  c o nt ai ni n g t h e I O L i nf or m ati o n  a n d  u ni q u e 
s eri al  n u m b er
 
A  p a c k a g e i ns ert  c o nt ai ni n g  dir e cti o ns f or  us e
L a b eli n g  d es cri pti o n 
Pr o d u ct  m ust  b e l o c all y  pr o c ur e d b y  t h e sit e vi a  c o m m er ci al 
c h a n n el  a n d  will  arri v e i n  c o u ntr y   c o m pli a nt  c o m m er ci al  p a c k a gi n g 
wit h  c o m m er ci al l a b el.
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  2 5 of  5 4
St or a g e  c o n diti o ns 
O n c e  d esi g n at e d f or st u d y  us e,  pr o d u ct  m ust  b e st or e d i n  a s af e, 
s e c ur e l o c ati o n  wit h li mit e d  a c c ess s e p ar at e d fr o m  g e n er al st o c k. 
Tr a ns p ort ati o n  of  pr o d u ct fr o m  o n e  a d dr ess t o  a n ot h er  m ust  b e 
d o c u m e nt e d  a n d  a  T r a ns p ort ati o n  Lo g ( or si mil ar  d o c u m e nt ati o n) 
utili z e d f or  a p pr o pri at e  a c c o u nt a bilit y.
Fi n al  Dis p ositi o n 
At t h e  c o n cl usi o n  of t h e st u d y , r e m ai ni n g  pr o d u ct  m a y  b e r et ur n e d 
t o t h e In v esti g at or ’s  g e n er al st o c k.
N O T E: R et ur n  d efi ci e nt  pr o d u ct t o t h e  m a n uf a ct ur er f oll o wi n g 
e a c h  m a n uf a ct ur er ’s r es p e cti v e  c o m pl ai nt  pr o c ess.  R ef er t o
S e cti o n 1 2. 5 f or f urt h er  d et ails  o n t h e r et ur n  pr o c ess f or  Al c o n 
pr o d u ct.  A d diti o n all y , t h e In v esti g at or  m ust f oll o w  a n y  r e c alls fr o m 
t h e  distri b ut or/ m a n uf a ct ur er.
S u p pl y
T h e I n v esti g at or  will l o c all y   pr o c ur e t h e I P t hr o u g h t h eir st a n d ar d 
c o m m er ci al  c h a n n el.
A d diti o n al 
i nf or m ati o n
I n  or d er t o i m pl a nt I OLs i n st u d y  s u bj e cts, t h e s ur g e o ns 
p arti ci p ati n g i n t h e st u d y  m ust  b e li c e ns e d o p ht h al m ol o gists  wit h 
c at ar a ct s ur g er y  e x p eri e n c e a n d tr ai n e d  o n t h e  pr ot o c ol .  E a c h 
s urg e o n  will f oll o w t h eir st a n d ar d  of  c ar e t o i m pl a nt t h e I OL 
f oll o wi n g r es p e cti v e  D F U i nstr u cti o ns f or I O L i m pl a nt.
1 0. 1. 1 
Ot h e r  M e di c al  D e vi c e  S p e cifi e d f o r  Us e  D u ri n g t h e  St u d y
T h e  T o p c o n  K R -1 W  W a v e -Fr o nt  A n al y z er  will  b e  us e d t o  c a pt ur e  a ut or efr a cti o n  v al u es f or 
t h e  pri m ar y  e n d p oi nt. T his  d e vi c e is C E  M ar k e d ,  F D A  a p pr o v e d a n d  will  b e  us e d f oll o wi n g 
t h e  m a n uf a ct ur er’s i nstr u cti o ns.
1 0. 2 
Tr e at m e nt Assi g n m e nt /  R a n d o mi z ati o n
O nl y   aft er si g ni n g t h e I CF ,  a s u bj e ct  will  b e  assi g n e d  a s u bj e ct  n u m b er  b y t h e  el e ctr o ni c  d at a 
c a pt ur e s ys t e m.  S u bj e cts  will  n ot  b e r an d o mi z e d i n t his st u d y . All s u bj e cts  will  b e i m pl a nt e d 
wit h  M o d el S N 6 0 W F I O L i n t h e s el e ct e d st u d y e y e a n d  m e as ur e d  o n  a ut o m at e d r efr a cti o n 
d e vi c e,  T o p c o n  K R -1 W  pr e o p er ati v el y  a n d  at  p ost o p er ati v e  visits .
1 0. 3 
A c c o u nt a bilit y  P r o c e d u r es
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
T h e I n v esti g at or  or  d el e g at e  m ust  pr o c ur e t h e I P  t hr o u g h t h eir st a n d ar d  c o m m er ci al  c h a n n el. 
O n c e  d esi g n at e d f or st u d y  us e, t h e I P   will  b e st or e d i n  a s af e, s e c ur e l o c ati o n  wit h li mit e d 
a c c ess s e p ar at e d fr o m  g e n er al st o c k.  T r a ns p ort ati o n  of I P fr o m  o n e  a d dr ess t o  a n ot h er  m ust 

P a g e  2 6 of  5 4
b e  d o c u m e nt e d  a n d  a  T r a ns p ort ati o n  Lo g ( or si mil ar  d o c u m e nt ati o n)  utili z e d f or  a p pr o pri at e 
a c c o u nt a bilit y. T hr o u g h o ut t h e st u d y , t h e I n v esti g at or  or  d el e g at e  m ust  m ai nt ai n r e c or ds  of I P 
us e f or  e a c h s u bj e ct.  T his r e c or d  m ust  b e  m a d e  a v ail a bl e t o t h e S p o ns or ’s m o nit or f or t h e 
p ur p os es  of  v erif y i n g t h e  a c c o u nti n g  of I P s u p pli es. A n y  dis cr e p a n ci es  a n d/ or  d efi ci e n ci es 
m ust  b e r e c or d e d  al o n g  wit h  a n  e x pl a n ati o n.  All I P   m ust  b e  a c c o u nt e d f or  b y  St u d y  S p o ns or 
p ers o n n el,  a n d i n  n o  c as e  b e  us e d i n a n  u n a ut h ori z e d  m a n n er .
 
If  p ossi bl e, r et ur n t o t h e  St u d y  S p o ns or, I P ass o ci at e d  wit h  a  d e vi c e  d efi ci e n c y .  R ef er 
t o S e cti o n  1 2 of t his  pr ot o c ol f or  a d diti o n al i nf or m ati o n  o n t h e r e p orti n g  of  d e vi c e 
d efi ci e n ci es a n d t o t h e  M a n u al  of  Pr o c e d ur es ( M O P ) f or i nfor m ati o n  o n r et ur n  of  I P
ass o ci at e d  wit h t h es e  e v e nts.
T h e I n v esti g at or is r es p o nsi bl e f or  pr o p er  dis p ositi o n  of  all  u n us e d I P   at t h e  c o n cl usi o n  of t h e 
st u d y t o t h e I n v esti g at or’s  g e n er al st o c k.
1 0. 4 
Tr e at m e nt  M as k i n g
T h e  e x a mi n e r p erf or mi n g t h e  m a nif est r efr a cti o n  m ust  b e  m as k e d t o t h e r efr a cti v e t ar g et  a n d 
r efr a cti v e err or fr o m t h e s urgi c al  pl a n ni n g  a n d t h e  o p er ati v e  visit , r es p e cti v el y.
1 0. 5 
C h a n g es t o  C o n c o mit a nt  Tr e at m e nts  o r  P r o c e d u r es
Aft er t h e s u bj e ct is  e nr oll e d i nt o t h e st u d y , t h e I n v esti g at or  m ust i nstr u ct t h e s u bj e ct t o  n otif y 
t h e st u d y sit e  a b o ut:
 
A n y   n e w  m e di c ati o ns 
 
Alt er ati o ns i n  d os e  or  d os e s c h e d ul es f or  c urr e nt  m e di c ati o ns, 
 
A n y   m e di c al  pr o c e d ur e  or  h os pit ali z ati o n t h at  o c c urr e d  or is  pl a n n e d
 
A n y   n o n-dr u g t h er a pi es (i n cl u di n g  p h ys i c al t h er a p y  a n d  bl o o d tr a nsf usi o ns). 
T h e I n v esti g at or  m ust  d o c u m e nt t his i nf or m ati o n i n t h e s u bj e ct’ s  c as e  hist or y s o ur c e 
d o c u m e nts.
1 1 
S T U D Y   P R O C E D U R E S A N D  A S S E S S M E N T S B Y   VI SI T
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
T h e f oll o wi n g s e cti o n  o utli n es t h e  ass ess m e nts t o  b e  p erf or m e d i n t his  cli ni c al  st u d y. 
Ass ess m e nts  ar e  d es cri b e d i n  d et ail i n t h e I L Q 7 3 2 -I 00 1  M O P,  a n d  ar e  o utli n e d i n t a b ul ar 
f or m at i n  S e cti o n  5  of t his  pr ot o c ol. 

P a g e  2 7 of  5 4
A Es , S A Es i n cl u di n g  S SI s  a n d d e vi c e  d efi ci e n ci es ar e  ass ess e d  a n d r e p ort e d  at  all  s c h e d ul e d 
a n d  u ns c h e d ul e d  visits ( U N S V) f or  e a c h s u bj e ct,  b e gi n ni n g  at t h e ti m e t h e i nf or m e d  c o ns e nt 
is  o bt ai n e d.
1 1. 1 
S c r e e ni n g/ P r e o p e r ati v e  V isit ( Visit  0)
Vi sit  0:  - 2 8-0  D a ys  P r i o r t o  Visit  0 0
B el o w is  a list  of st u d y  pr o c e d ur es t o  b e  d o n e  at  V isit  0. All  as s ess m e nts  m ust  b e  d o c u m e nt e d 
i n t h e s o ur c e  d o c u m e nt ati o n  a n d el e ctr o ni c  c as e r e p ort f or m ( e C R F), i f  a p pli c a bl e.
N O T E: At t h e  S cr e e ni n g/ Pr e o p er ati v e  V isit ( Visit  0)  all  ass ess m e nts t o  b e  c o m pl et e d 
m o n o c ul arl y   o n t h e st u d y  e ye  o nl y,  w h er e  a p pli c a bl e.
N O T E: P er t h e I n v esti g at or ’s  dis cr eti o n,  d at a fr o m  pr e vi o us  c at ar a ct  e v al u ati o n  visit(s)  m a y 
b e  us e d.  T his  d at a  m a y  c o m e fr o m  m or e t h a n  o n e r o uti n e  visit  c o n d u ct e d  wit hi n  4  m o nt hs  of 
t h e  S cr e e ni n g/ Visit  0  wit h t h e  e x c e pti o n  of t h os e  ass ess m e nts t h at  ar e  cr u ci al to t h e I O L  
p o w er  c al c ul ati o n.
N O T E: T o   e ns ur e t h e st a bilit y  of r efr a cti o n, s u bj e cts  w h o  c urr e ntl y w e ar  c o nt a ct l e ns es t h e y
m ust dis c o nti n u e t h eir  us e pri or t o  c o m pl eti n g t h e  S cr e e ni n g/ Pr e o p er ati v e  V isit ( Visit  0)  as 
f oll o ws:
 
H ar d  or ri gi d  c o nt a ct l e ns es -  3 w e e ks 
 
S oft  c o nt a ct l e ns es  – 2  w e e ks
1. R e vi e w st u d y  s p e cifi c i n cl usi o n/ e x cl usi o n  crit eri a ( e g,  a g e,  pr e vi o us  o c ul ar  hist or y) t o 
e ns ur e t h at  a  p ot e nti al s u bj e ct  m e ets  all  q u alifi c ati o ns f or  p arti ci p ati o n i n t h e st u d y .
2. F or  a  p ot e nti al s u bj e ct  m e eti n g  all  e ntr y  crit eri a  vi a  pr e -s cr e e ni n g, i n vit e  hi m/ h er t o 
p arti ci p at e i n t h e st u d y ,  a n d  c arr y  o ut t h e i nf or m e d  c o ns e nt  pr o c ess if t h e y  ar e 
i nt er est e d.  R ef er t o S e cti o n  1 1 . 7 I nf or m e d  C o ns e nt  Pr o c e d ur es.
3. P erf or m  a  uri n e  pr e g n a n c y t est,  I F
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
t h e s u bj e ct is  a  w o m a n  of  c hil d b e ari n g  p ot e nti al.
4. Ass ess  A C D,  A L a n d  w hit e -t o-w hit e  dist a n c e.
5. P erf or m  k er at o m etr y   m e as ur e m e nts t o  e v al u at e t h e  c ur v at ur e  of t h e  a nt eri or s urf a c e 
of t h e  e y e.
6. Ass ess l e ns t hi c k n ess.

P a g e  2 8 of  5 4
7. C a pt ur e  a b err o m etr y , t o p o gr a p h y,  k er at o m etry,   p u pill o m etr y  a n d  a ut or efr a cti o n wit h 
t h e T o p c o n K R -1 W  W a v e -Fr o nt  A n al y z er .
8. P erf or m  m a nif est r efr a cti o n .
9.   M e as ur e  a n d r e c or d  u n c orr e ct e d dist a n c e  vis u al  a c uit y  ( U D VA) a n d  c orr e ct e d 
dist a n c e  vis u al  a c uit y ( C D V A)
1 0. D o c u m e nt t h e t ar g et r esi d u al r efr a cti v e  err or  b as e d  o n t h e I O L   c al c ul ati o n  p o w er.
1 1. M e as ur e  a n d r e c or d p h ot o pi c p u pil  di a m et er ( dil at e d  a n d  u n dil at e d).
1 2. C o n d u ct slit -l a m p  e x a mi n ati o n.
1 3. C o n d u ct  dil at e d f u n d us  e x a mi n ati o n.
1 4. P erf or m t o n o m etr y  t o  m e as ur e I O P.
1 5. R e c or d  a n y  A Es.  R ef er  t o  S e cti o n 1 2 f or f urt her  d et ails.
1 6.   E v al u at e s u bj e ct  a g ai nst  all  e ntr y  crit eri a. If s u bj e ct f ails  crit eri a,  s cr e e n f ail t h e 
s u bj e ct.
1 7. I de ntif y  th e s ur gi c al  e y e f or t his st u d y ( d et er mi n e d  b y t h e I n v esti g at or)
1 8. Pr o c e e d  wit h s c h e d uli n g t h e s ur g er y .
1 1. 2 
O p e r ati v e  Vi sit ( Visit  0 0)
Vi sit  0 0: D a y  0,  St u d y  E y e I m pl a nt ati o n
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
B el o w is  a list  o f  pr o c e d ur es t o  b e  c o m pl et e d  at Vi sit  0 0. A cti viti es i n v ol vi n g  m ulti pl e 
d el e g at e d st af f  m e m b ers  m a y  b e  p erf or m e d i n  p ar all el. All  ass ess m e nts  m ust  b e  d o c u m e nt e d 
i n s o ur c e  d o c u m e nt ati o n  a n d e C R F , if  a p pli c a bl e.
1. Pri or t o s ur g er y , r e vi e w i n cl usi o n/ e x cl usi o n  crit eri a  a n d  e ns ur e t h e s u bj e ct  h as  b e e n 
pr o p erl y  c o ns e nt e d f or  p arti ci p ati o n i n t h e st u d y .
2. D o c u m e nt  a n y  c h a n g es t o  o c ul ar  a n d  n o n -o c ul ar  c o n c o mit a nt  m e di c ati o ns.
3. R e c or d  o p er ati v e  e y e.
4. M e as ur e  a n d r e c or d  p h ot o pi c  p u pil  di a m et er ( dil at e d  a n d  u n dil at e d).

P a g e  2 9 of  5 4
5. Pr e p ar e s u bj e ct f or s ur g er y i n  a c c or d a n c e t o sit e -s p e cifi c  o p er ati n g  pr o c e d ur es.
6.   R e c or d t h e f ol di n g  a n d i ns erti o n i nstr u m e nt  us e d.
7. R e c or d t h e fi n al i n cisi o n si z e  a n d i n cisi o n sit e.
8. R e c or d  a n y s ur gi c al  pr o bl e ms,  c o m pli c ati o ns,  or  ot h er  pr o c e d ur es t h at  o c c ur  d uri n g 
s urg er y .  Ot h er  pr o c e d ur es i n cl u d e t h os e  p erf or m e d  o utsi d e  of r o uti n e  c at ar a ct s ur g er y.
9. R e c or d t h e l e ns i nf or m ati o n t h at is l o c at e d  o n t h e I O L  sti c k er.  B ot h s u c c essf ul  a n d 
a b ort e d (if  a p pli c a bl e)  I OL  i nf or m ati o n s h o ul d  b e r e c or d e d.
1 0. R e c or d  a n y  A Es i n cl u di n g  S SIs.
N O T E: S A Es i n cl u di n g  S SI s  m ust  b e  e nt er e d i nt o  t h e e C R F s yst e m wit hi n  2 4  h o urs 
of t h e I n v esti g at or ’s  k n o wl e d g e.  R ef er t o S e cti o n  1 2 f or f urt h er  d et ails.
1 1. R e c or d  a n y  d e vi c e  d efi ci e n ci es.  R ef er t o  S e cti o n  1 2 f or f urt h er  d et ails.
1 1. 3 
P ost o p e r ati v e  Vi sit ( Visit 1)
Vi sit  1: 2 0- 4 0 D a ys  P ost  St u d y  E y e I m pl a nt ati o n
B el o w is  a list  o f  pr o c e d ur es t o  b e  c o m pl et e d  at Vi sit 2.  All  ass ess m e nts  m ust  b e  d o c u m e nt e d 
i n s o ur c e  d o c u m e nt ati o n  a n d e C R F , if  a p pli c a bl e.
N O T E :
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
All  p ost o p er ati v e  ass ess m e nts t o  b e  c o m pl et e d  m o n o c ul arl y  o n t h e  o p er ati v e  e y e 
o nl y ,  as  a p pli c a bl e.
1. D o c u m e nt  a n y  c h a n g es t o  m e di c al/ o c ul ar  hist or y   a n d  o c ul ar  a n d  n o n-o c ul ar 
c o n c o mit a nt  m e di c ati o ns.
2. R e c or d l e ns t hi c k n ess of t h e I O L .
3. C a pt ur e  a b err o m etr y , t o p o gr a p h y,  k er at o m etr y,  p u pill o m etr y  a n d  a ut or efr a cti o n  wit h 
t h e T o p c o n K R -1 W  W a v e -Fr o nt  A n al y z er.
4. P erf or m  m a nif est r efr a cti o n.
5. M e as ur e  a n d r e c or d  U D V A  a n d  C D VA.
6. P erf or m slit -l a m p  e x a mi n ati o n  of t h e  a nt eri or s e g m e nt. In cl u d e  d o c u m e nt a ti o n  of IO L  
o bs er v ati o ns, if  a n y.  

P a g e  3 0 of  5 4
7. O bs er v e  a n y  I OL  p ositi o n  c h a n g es (i e, tilt  a n d  d e c e ntr ati o n)  o c c urri n g si n c e t h e 
pr e vi o us  visit.
8. Ass ess s u bj e cti v e  P C O,  a n d r e c or d i nf or m ati o n f or  a n y  P C t h at  h as  o c c urr e d si n c e 
s urg er y , if  a p pli c a bl e.
9. P erf or m t o n o m etr y  t o  m e as ur e I O P.
1 0. R e c or d  a n y  A Es i n cl u di n g  S SI s
N O T E: S A Es i n cl u di n g  S SI s  m ust  b e  e nt er e d i nt o t h e  e C R F wit hi n  2 4  h o urs  of t h e 
I n v esti g at or’s  k n o wl e d g e.  R ef er t o S e cti o n  1 2  f or f urt h er  d et ails.
1 1. R e c or d  a n y  d e vi c e  d efi ci e n ci es.  R ef er t o  S e cti o n  1 2 f or f urt h er d et ails.
1 1. 4 
P ost o p e r ati v e  Vi sit ( Visit 2)
Vi sit  2: 8 0- 1 0 0 D a ys  P ost  St u d y  E y e I m pl a nt ati o n
B el o w is  a list  o f  pr o c e d ur es t o  b e  c o m pl et e d  at Vi sit 3.  All  ass ess m e nts  m ust  b e  d o c u m e nt e d 
i n s o ur c e  d o c u m e nt ati o n  a n d e C R F, if  a p pli c a bl e.
N O T E:
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
All  p ost o p er ati v e  as s ess m e nts t o  b e  c o m pl et e d  m o n o c ul arl y  o n t h e  o p er ati v e  e y e 
o nl y ,  as  a p pli c a bl e.
1. D o c u m e nt  a n y  c h a n g es t o  m e di c al/ o c ul ar  hist or y   a n d  o c ul ar  a n d  n o n-o c ul ar 
c o n c o mit a nt  m e di c ati o ns.
2. Ass ess  A C D,  A L   a n d  w hit e-t o-w hit e  dist a n c e.
3. Ass ess l e ns t hi c k n ess of t h e I O L .
4. P erf or m  k er at o m etr y   m e as ur e m e nts t o  e v al u at e t h e  c ur v at ur e  of t h e  a nt eri or s urf a c e 
of t h e  e y e.
5. C a pt ur e  a b err o m etr y , t o p o gr a p h y,  k er at o m etr y,  p u pill o m etr y  a n d  a ut or efr a cti o n  wit h 
t h e T o p c o n K R -1 W  W a v e -Fr o nt  A n al y z er.
6. R e c or d  a ct u al l e ns  p ositi o n, t h e  pl a n e  b is e cti n g t h e I O L.
7.   R e c or d  c a ps ul or h e xis  di a m et er.
8. P erf or m  m a nif est r efr a cti o n.

P a g e  3 1 of  5 4
9. M e as ur e  a n d r e c or d  U D V A  a n d  C D VA.
1 0. M e as ur e  a n d r e c or d  p h ot o pi c  p u pil  di a m et er ( dil at e d  a n d  u n dil at e d).
9. P erf or m slit -l a m p  e x a mi n ati o n  of t h e  a nt eri or s e g m e nt. In cl u d e  d o c u m e nt ati o n of I O L  
o bs er v ati o ns, if  a n y.
1 0. C o n d u ct  dil at e d f u n d us  e x a mi n ati o n.
1 1. O bs er v e  a n y  I OL  p ositi o n  c h a n g es (i e, tilt  a n d  d e c e ntr ati o n)  o c c urri n g si n c e t h e 
pr e vi o us  visit.
1 2. Ass ess s u bj e cti v e  P C O,  a n d r e c or d i nf or m ati o n f or  a n y  P C t h at  h as  o c c urr e d si n c e 
s urg er y , if a p pli c a bl e.
1 3. P erf or m t o n o m etr y  t o  m e as ur e I O P.
1 4. R e c or d  a n y  A Es i n cl u di n g  S SI s
N O T E: S A Es i n cl u di n g  S SI s  m ust  b e  e nt er e d i nt o  e C R F wit hi n  2 4  h o urs  of t h e 
I n v esti g at or’s  k n o wl e d g e.  R ef er t o  S e cti o n 1 2 f or f urt h er  d et ails.
1 5. R e c or d  a n y  d e vi c e  d efi ci e n ci es.  R ef er  t o  S e cti o n 1 2  f or f urt h er  d et ails.
1 1. 5 
S c h e d ul e  of  P r o c e d u r es  a n d  Ass ess m e nts f o r  Dis c o nti n u e d 
S u bj e cts
S u bj e cts t h at  dis c o nti n u e fr o m t h e st u d y ,  all  eff orts  m ust  b e  m a d e t o  c o m pl et e t h e 
ass ess m e nts  n ot e d i n t h e t a bl e i n S e cti o n  5 f or  a n  E arly  E xit  V isit.
N O T E:
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
All  ass ess m e nts t o  b e  c o m pl et e d  m o n o c ul arl y   o n t h e  o p er ati v e  e ye  o nl y,  as 
a p pli c a bl e.
1. D o c u m e nt  a n y  c h a n g es t o  m e di c al/ o c ul ar  hist or y   a n d  o c ul ar  a n d  n o n-o c ul ar 
c o n c o mit a nt  m e di c ati o ns.
2. P erf or m  m a nif est r efr a cti o n.
3. M e as ur e  a n d r e c or d  U D V A  a n d  C D VA.
4. P erf or m slit -l a m p  e x a mi n ati o n  of t h e  a nt eri or s e g m e nt. In cl u d e  d o c u m e nt ati o n  of I O L  
o bs er v ati o ns, if  a n y.

P a g e  3 2 of  5 4
5. C o n d u ct  dil at e d f u n d us  e x a mi n ati o n.
6. O bs er v e  a n y  I OL  p ositi o n  c h a n g es (i e, tilt  a n d  d e c e ntr ati o n)  o c c urri n g si n c e t h e 
pr e vi o us  visit.
7. Ass ess s u bj e cti v e P C O,  a n d r e c or d i nf or m ati o n f or  a n y  P C t h at  h as  o c c urr e d si n c e 
s urg er y , if  a p pli c a bl e.
8. P erf or m t o n o m etr y  t o  m e as ur e I O P.
9. R e c or d  a n y  A Es i n cl u di n g  S SI s
N O T E: S A Es i n cl u di n g  S SI s  m ust  b e  e nt er e d i nt o  e C R F wit hi n  2 4  h o urs  of t h e 
I n v esti g at or’s  k n o wl e d g e.  R ef er t o  S e cti o n  1 2 f or f urt h er  d et ails.
1 0. R e c or d  a n y  d e vi c e  d efi ci e n ci es.  R ef er t o  S e cti o n  1 2 f or f urt h er  d et ails.
1 1. 6 
I nf o r m e d  C o ns e nt  a n d  S c r e e ni n g
T h e s u bj e ct  m ust  si g n t h e I CF  B E F O R E a n y st u d y s p e cifi c  pr o c e d ur es  or  ass ess m e nts  c a n  b e 
p erf or m e d. 
T h e I n v esti g at or  m ust  e x pl ai n t h e  p ur p os e  a n d  n at ur e  of t h e st u d y ,  a n d  h a v e t h e s u bj e ct r e a d, 
si g n,  a n d  d at e t h e I E C/I R B a p pr o v e d i nf or m e d  c o ns e nt  d o c u m e nt.  A d diti o n all y ,  h a v e t h e 
i n di vi d u al  o bt ai ni n g  c o ns e nt fr o m t h e s u bj e ct si g n  a n d  d at e t h e i nf or m e d  c o ns e nt  d o c u m e nt.
T h e I n v esti g at or  m ust  pr o vi d e  a  c o p y  of t h e si g n e d  d o c u m e nt t o t h e s u bj e ct  a n d  pl a c e t h e 
ori gi n al si g n e d  d o c u m e nt i n t h e s u bj e ct’s  c h art,  or  pr o vi d e  d o c u m e nt ati o n  as r e q uir e d  b y 
l o c al r e g ul ati o ns.
1 1. 7 
U ns c h e d ul e d  Vi sits
A n  U N S V is  d efi n e d  as f oll o ws:
 
O c ul ar  e x a mi n ati o n t h at is  n ot st a n d ar d  of  c ar e  a n d  n ot r e q uir e d  b y t h e  pr ot o c ol
 
E x a mi n ati o n  c o n d u ct e d  b y t h e st u d y st aff
 
N e w fi n di n gs,  or  a  c h a n g e t o  a  pr e vi o us fi n di n g  w as  dis c o v er e d

A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
N ot sit e st a n d ar d  of  c ar e /r o uti n e

P a g e  3 3 of  5 4
A n  U N S V m a y   or  m a y  n ot r es ult i n t h e  c a pt ur e  of  a n A E.  Li k e wis e  a n  A E  m a y   b e  c a pt ur e d 
wit h o ut t h e r e p ort  of  a n  U N S V ( e g, A E i d e ntifi e d s u bs e q u e nt t o st u d y   e ye  e x a mi n ati o n  b y  
n o n- st u d y  p ers o n n el).
D uri n g  all  U N S V s, it is r e c o m m e n d e d t h at t h e I n v esti g at or c o m pl et e t h e f oll o wi n g 
pr o c e d ur es as  a p pr o pri at e f or t h e  o p er ati v e  e ye : 
1. D o c u m e nt  a n y  c h a n g es t o  m e di c al/ o c ul ar  hist or y   a n d  o c ul ar  a n d  n o n-o c ul ar 
c o n c o mit a nt  m e di c ati o ns.
2. P erf or m  m a nif est r efr a cti o n.
3. M e as ur e  a n d r e c or d  u n c orr e ct e d  a n d  b est c orr e ct e d  dist a n c e  V A .
4. P erf or m slit -l a m p  e x a mi n ati o n  of t h e  a nt eri or s e g m e nt. In cl u d e  d o c u m e nt ati o n  of I O L  
o bs er v ati o ns, if  a n y.
5. C o n d u ct  dil at e d f u n d us  e x a mi n ati o n.
6. O bs er v e  a n y  I OL  p ositi o n  c h a n g es (i e, tilt  a n d  d e c e ntr ati o n)  o c c urri n g si n c e t h e 
pr e vi o us  visit.
7. Ass ess s u bj e cti v e  P C O,  a n d r e c or d i nf or m ati o n f or  a n y  P C t h at  h as  o c c urr e d si n c e 
s urg er y , if  a p pli c a bl e.
8. P erf or m t o n o m etr y  t o  m e as ur e I O P.
9. R e c or d  a n y  A Es i n cl u di n g  S SI s.
N O T E:
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
S A Es i n cl u di n g  S SI s  m ust  b e  e nt er e d i nt o  e C R F wit hi n  2 4  h o urs  of t h e 
I n v esti g at or ’s  k n o wl e d g e.  R ef er t o  S e cti o n  1 2 f or f urt h er  d et ails.
1 0. R e c or d  a n y  d e vi c e  d efi ci e n ci es.  R ef er t o  S e cti o n  1 2 f or f urt h er  d et ails.
T h e I n v esti g at or  m a y   p erf or m  a d diti o n al  pr o c e d ur es f or  pr o p er  di a g n osis  a n d tr e at m e nt  of t h e 
s u bj e ct. T h e I n v esti g at or  m ust  d o c u m e nt t his i nf or m ati o n i n t h e s u bj e ct’ s  c as e  hist or y s o ur c e 
d o c u m e nts.
If  d uri n g  a n U N S V t h e s u bj e ct is  dis c o nti n ui n g fr o m t h e st u d y, t h e n t h e I n v esti g at or  m ust 
c o n d u ct  E arl y  E xit/ E xit  pr o c e d ur es  a c c or di n g t o  S e cti o n  5, S c h e d ul e  of  St u d y   Pr o c e d ur es a n d 
Ass ess m e nts.

P a g e  3 4 of  5 4
1 1. 8 
Dis c o nti n u e d  S u bj e cts
1 1. 8. 1 
S c r e e n  F ail u r es
S u bj e cts  w h o  dis c o nti n u e fr o m t h e st u d y   pri or t o t h e  O p er ati v e  Visit ( Visit  0 0)  will  b e 
c at e g ori z e d  as s cr e e n f ail ur es.
T h e I n v esti g at or  m a y  r e pl a c e  a s u bj e ct  w h o f ails st u d y S cr e e ni n g/ V isit  0, b ut  t h e s u bj e ct 
n u m b er m ust n ot  b e r e -us e d. T h e I n v esti g at or  m ust  d o c u m e nt t h e r e as o n f or s cr e e n f ail ur e i n 
t h e s u bj e ct’s  c as e  hist or y s o ur c e  d o c u m e nts a n d  el e ctr o ni c  d at a  c a pt ur e ( E D C ).
1 1. 8. 2 
Dis c o nti n u ati o ns
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
Dis c o nti n u e d s u bj e cts  ar e i n di vi d u als  w h o  h a v e si g n e d i nf or m e d  c o ns e nt  a n d  w h o  v ol u nt aril y  
wit h dr a w  or  ar e  wit h dr a w n fr o m t h e st u d y   b y t h e In v esti g at or  at t h e  Vi sit  0 0/ O p er ati v e Vi sit 
a n d/ or  pri or t o  c o m pl eti n g  all st u d y  visits.
S u bj e cts t h at  m e et  E x cl usi o n  Crit eri a  at t h e ti m e  of s ur g er y ( r ef er t o S e cti o n  9 . 3)  m ust  b e 
c a pt ur e d  as  dis c o nti n u ati o ns.
Dis c o nti n u e d s u bj e cts  will  n ot  b e r e pl a c e d; s u bj e ct  n u m b ers  of  dis c o nti n u e d s u bj e cts  m ust 
n ot  b e r e -us e d.
S u bj e cts  m a y  dis c o nti n u e fr o m st u d y   at  a n y ti m e f or  a n y r e as o n.  S u bj e cts  m a y  als o  b e 
dis c o nti n u e d  at  a n y ti m e if, i n t h e  o pi ni o n  of t h e I n v esti g at or ,  c o nti n u e d st u d y  p arti ci p ati o n 
p os es  a ris k t o t h eir  h e alt h.
If  a s u bj e ct  dis c o nti n u es fr o m t h e st u d y  aft er Vi sit  0 0/ O p er ati v e Vi sit,  e v er y  eff ort m ust b e 
m a d e t o  k e e p t h e s u bj e ct i n t h e st u d y   a n d t o  c o nti n u e  wit h th e st u d y   ass ess m e nts  as s p e cifi e d 
i n t h e s c h e d ul e  of st u dy  pr o c e d ur es  a n d  ass ess m e nts  u ntil t h e fi n al  visit.
F or s u bj e cts  dis c o nti n ui n g fr o m t h e st u d y , t h e I n v esti g at or s h o ul d c o m pl et e  all  E arl y  E xit 
pr o c e d ur es  a c c or di n g t o  S e cti o n  5  S c h e d ul e  of  St u d y   Pr o c e d ur es  a n d Ass ess m e nts, if t h e 
s u bj e ct is  willi n g  a n d  a bl e,  a n d if i n t h e  o pi ni o n  of t h e I n v esti g at or it is  s af e f or t h e s u bj e ct t o 
d o s o.
T h e I n v esti g at or  m ust  d o c u m e nt t h e r e as o n f or st u d y   dis c o nti n u ati o n i n t h e s u bj e ct’s  c as e 
hist o r y s o ur c e  d o c u m e nts a n d  c o m pl et e t h e  e xit f or m i n  E D C .
T o   e ns ur e t h e s af ety  of  all s u bj e cts  w h o  dis c o nti n u e  e arl y,  In v esti g at ors  m ust  ass ess  e a c h 
s u bj e ct  a n d, if  n e c ess ar y,  a d vis e t h e m  of  a n y t h er a pi es  a n d/ or  m e di c al  pr o c e d ur es t h at  m a y  b e 
n e e d e d t o  m ai nt a i n t h eir  h e alt h.

P a g e  3 5 of  5 4
1 1. 9 
Cli ni c al  St u d y  Te r mi n ati o n
T h e  St u d y   S p o ns or r es er v es t h e ri g ht t o  cl os e t h e i n v esti g ati o n al sit e  or t er mi n at e t h e st u d y i n 
its  e ntir et y  at  a n y ti m e, f or r e as o n a bl e  c a us e.
If t h e  cli ni c al st u dy is  pr e m at ur el y t er mi n at e d  or s us p e n d e d  b y t h e St u d y   S p o ns or: 
 
T h e  St u d y   S p o ns or  m ust:
 
I m m e di at el y  n otif y t h e I n v esti g at or(s)  a n d s u bs e q u e ntl y  pr o vi d e i nstr u cti o ns f or 
st u d y t er mi n ati o n.  
 
I nf or m t h e I n v esti g at or  a n d t h e r e g ul at or y  a ut h oriti es  of t h e 
t er mi n ati o n/s us p e nsi o n  a n d t h e r e as o n(s) f or t h e t er mi n ati o n/s us p e nsi o n. 
 
T h e I n v esti g at or  m ust:
 
Pr o m ptl y   n otif y t h e I E C/I R B  of t h e t er mi n ati o n  or s us p e nsi o n  a n d  of t h e r e as o ns. 
 
Pr o vi d e s u bj e cts  wit h r e c o m m e n d ati o ns f or  p ost -st u d y tr e at m e nt  o pti o ns  as 
n e e d e d.
T h e I n v esti g at or  m a y  t er mi n at e t h e sit e’s  p arti ci p ati o n i n t h e st u d y f or r e as o n a bl e  c a us e.  
1 1. 1 0 
A b o rt e d I m pl a nt ati o n 
1 1. 1 0. 1 
A b o rt e d I niti al I m pl a nt ati o n
I F t h e I O L i m pl a nt  w as  a b ort e d  a n d t h e t est  arti cl e di d  n ot t o u c h t h e  e ye  T H E N
 
A  s e c o n d  att e m pt is  p er mitt e d
 
If t h e s u bj e ct is r e q uir e d t o  dis c o nti n u e fr o m t h e st u d y, f oll o w st a n d ar d  of  c ar e f or 
I OL  i m pl a nt ati o n 
I F t h e I OL  i m pl a nt  w as  a b ort e d  a n d t h e t est  arti cl e di d t o u c h t h e  e ye  T H E N
 
A  s e c o n d  att e m pt is  p er mitt e d
 
If t h e s u bj e ct is  dis c o nti n u e d fr o m t h e st u dy
o 
E n c o ur a g e t h e s u bj e ct t o  att e n d  all f oll o w- u p st u d y  visits f or s af et y  e v al u ati o n 
o n t his  e y e  o nl y
o
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
St a n d ar d  of  c ar e f oll o w e d f or I O L i m pl a nt ati o n 

P a g e  3 6   of 5 4
1 1. 1 0. 2 
A b o rt e d  S e c o n d I m pl a nt ati o n
I F t h e s e c o n d  att e m pt t o i m pl a nt t h e IO L   w as  a b ort e d  a n d t h e t est  arti cl e di d  n ot  to u c h t h e 
e y e  o n  eit h er  att e m pt  T H E N
 
S u bj e ct  m ust  b e  dis c o nti n u e d fr o m t h e st u d y
 
St a n d ar d  of  c ar e f oll o w e d f or I O L  i m pl a nt ati o n 
I F t h e s e c o n d  att e m pt t o i m pl a nt t h e IO L   w as  a b ort e d  a n d t h e t est  arti cl e di d  t o u c h t h e  e ye  o n 
eit h er  att e m pt  T H E N
 
T his  e y e  m ust  b e f oll o w e d f or  all st u d y   visits f or s af ety  e v al u ati o n  o nl y
 
St a n d ar d  of  c ar e f oll o w e d f or I O L  i m pl a nt ati o n
1 2 
D E VI C E  D E FI CI E N CI E S  A N D  A D V E R S E  E V E N T S
1 2. 1 
G e n e r al I nf o r m ati o n
A n  A E is  a n y  u nt o w ar d  m e di c al  o c c urr e n c e,  u ni nt e n d e d  dis e as e  or i nj ur y,  or  u nt o w ar d 
cli ni c al si g ns (i n cl u di n g  a b n or m al l a b or at or y  fi n di n gs) i n s u bj e cts,  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  cli ni c al i n v esti g ati o n.
Fi g u r e  1 2 – 1 
C at e g o ri z ati o n  of  All  A d v e rs e  E v e nts
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  3 7   of 5 4
Fi g u r e  1 2 – 2 
C at e g o ri z ati o n  of  All  S e ri o us  A d v e rs e  E v e nts
1 2. 2 
S e ri o us  A d v e rs e  E v e nts
A  s eri o us  a d v ers e  e v e nt is  a n A E t h at l e d t o  a n y  o f t h e f oll o wi n g: 
 
D e at h.
 
A s eri o us  d et eri or ati o n i n t h e  h e alt h  of t h e s u bj e ct t h at eit h er r es ult e d i n:
a) a lif e -t hr e at e ni n g ill n ess  or i nj ur y. 
N O T E: Lif e -t hr e at e ni n g  m e a ns t h at t h e i n di vi d u al  w as  at i m m e di at e ris k  of  d e at h 
fr o m t h e  e v e nt  as it  o c c urr e d, i e, it  d o es  n ot i n cl u d e  a n  e v e nt  w hi c h  h y p ot h eti c all y 
mi g ht  h a v e  c a us e d  d e at h  h a d it  o c c urr e d i n  a  m or e s e v er e f or m.
b) a n y   p ot e nti all y si g ht-t hr e at e ni n g  e v e nt  or  p er m a n e nt i m p air m e nt t o  a  b o d y 
str u ct ur e  or  a  b o d y f u n cti o n. 
c) i n-p ati e nt  h os pit ali z ati o n  or  pr ol o n g e d  h os pit ali z ati o n. 
N O T E: Pl a n n e d  h os pit aliz ati o n f or  a  pr e -e xisti n g  c o n diti o n,  w it 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 e d  a  S A E. I n  g e n er al,  h os pit aliz ati o n 
si g nifi es t h at t h e i n di vi d u al r e m ai n e d  at t h e  h os pit al  or  e m er g e n c y  w ar d f or 
o bs er v ati o n  a n d/ or tr e at m e nt ( us u all y i n v ol vi n g  a n  o v er ni g ht st a y) t h at  w o ul d  n ot 
h a v e b e e n  a p pr o pri at e i n t h e  p h ysi ci a n's  offi c e  or  a n  o ut -p ati e nt s etti n g. 
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6

P a g e  3 8 of  5 4
C o m pli c ati o ns t h at  o c c ur  d uri n g  h os pit aliz ati o n  ar e  A Es. If  a  c o m pli c ati o n 
pr ol o n gs  h os pit aliz ati o n  or f ulfills  a n y  ot h er s eri o us  crit eri a, t h e  e v e nt is s eri o us. 
W h e n i n  d o u bt  as t o  w h e t h er  “ h os pit aliz ati o n ”  o c c urr e d, t h e  e v e nt s h o ul d  b e 
c o nsi d er e d s eri o us.
d) a  m e di c al  or s ur gi c al i nt er v e nti o n t o  pr e v e nt  a)  or  b)  or  a n y  o c ul ar s e c o n d ar y 
s ur gi c al i nt er v e nti o n ( e x cl u di n g  P C).
e) a n y  i n dir e ct  h ar m  as  a  c o ns e q u e n c e  of i n c orr e ct  di a g n osti c t est r es ults  w h e n  us e d 
wit hi n  m a n uf a ct ur er ’s i nstr u cti o ns f or  us e.
 
F et al  distr ess, f 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 e ct.
1 2. 3  
S p e cifi c  E v e nts  R el e v a nt t o t his  P r ot o c ol
I n  a d diti o n t o r e p orti n g  all  A Es (s eri o us  a n d  n o n-s eri o us) m e eti n g t h e  d efi niti o ns, t h e 
I n v esti g at or  m ust r e p ort  a n y  o c c urr e n c e  of t h e f oll o wi n g  as  a n  S A E:
1 2. 3. 1 
C u m ul ati v e  S e ri o us  A d v e rs e  E v e nts
 
C y st oi d  m a c ul ar  e d e m a
 
H y p o p y o n
 
E n d o p ht h al mitis
 
L e ns  disl o c ati o n
 
P u pill ar y   bl o c k
 
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
1 2. 3. 2 
P e rsist e nt  S e ri o us  A d v e rs e  E v e nts
 
C or n e al str o m al  e d e m a
 
C y st oi d  m a c ul ar  e d e m a
 
Iritis

A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
R ais e d I O P r e q uiri n g tr e at m e nt
T his list is  c o nsist e nt  wit h t h e  c at e g ori es  pr o vi d e d i n I . S.  E N I S O  1 1 9 7 9- 7: 2 0 1 4. A  p ersist e nt 
A E is  a n  A E t h at is  pr es e nt  at t h e  c o n cl usi o n  of  a  cli ni c al i n v esti g ati o n  p er I. S.  E N  I SO 

P a g e  3 9 of  5 4
1 1 9 7 9- 1.  A n y   ot h er  p ot e nti all y si g ht-t hr e at e ni n g  e v e nt  m a y  als o  b e  c o nsi d er e d s eri o us  b as e d 
o n t h e j u d g m e nt  of t h e  I nv esti g at or  a n d  m ust b e r e p ort e d  a p pr o pri at el y  as  d eli n e at e d i n 
S e cti o n  1 2. 6.
1 2. 4 
Te r mi n ol o g y
1 2. 4. 1 
A d v e rs e  D e vi c e  Eff e ct
A n  A D E is  a n  A E r el at e d t o t h e  cli ni c al i n v esti g ati o n.   T his  d efi niti o n i n cl u d es  A Es r es ulti n g 
fr o m i ns uffi ci e nt  or i n a d e q u at e i nstr u cti o ns f or  us e,  d e pl o ym e nt, i m pl a nt ati o n, i nst all ati o n,  or 
o p er ati o n;  a n y  m alf u n cti o n;  a n d  us e  err or  or i nt e nti o n al  m is us e  of t h e d e vi c e . 
1 2. 4. 2 
S e ri o us  A d v e rs e  D e vi c e  Eff e ct 
A  S A D E is  a n  A D E t h at  h as r es ult e d i n  a n y  of t h e  c o ns e q u e n c es  c h ar a ct eristi c  of  a  S A E.
1 2. 4. 3 
A nti ci p at e d  S e ri o us  A d v e rs e  D e vi c e  Eff e ct
A n  A S A D E is  a  S A D E  w hi c h  b y  its  n at ur e, i n ci d e n c e, s e v erit y,  or  o ut c o m e  h as  b e e n 
i d e ntifi e d i n t h e ris k  a n al ysis r e p ort.
1 2. 4. 4 
U n a nti ci p at e d  S e ri o us  A d v e rs e  D e vi c e  Eff e ct
A n  U S A D E is  a  S A D E  w hi c h  b y its  n at ur e, i n ci d e n c e, s e v erit y  or  o ut c o m e  h as  n ot  b e e n 
i d e ntifi e d i n t h e ris k  a n al ysis r e p ort.
1 2. 4. 5 
D e vi c e  D efi ci e n ci es
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
A  d e vi c e  d efi ci e n c y  is  a n i n a d e q u a c y  of  a  m e di c al  d e vi c e  wit h r es p e ct t o its i d e ntit y,  q u alit y, 
d ur a bilit y , r eli a bilit y, s af et y,  or  p erf or m a n c e.  T his  d efi niti o n i n cl u d es  m alf u n cti o ns,  us e 
err ors,  a n d i n a d e q u at e l a b eli n g.  M alf u n cti o n is  d efi n e d  as  a f ail ur e  of  a  m e di c al  d e vi c e  t o 
p erf or m i n  a c c or d a n c e  wit h its i nt e n d e d  p ur p os e  w h e n  us e d i n  a c c or d a n c e  wit h t h e 
i nstr u cti o ns f or  us e  or  cli ni c al i n v esti g ati o n  pl a n.  Us e  err or is  d efi n e d  as  a n  a ct  or  o missi o n  of 
a n  a ct t h at r es ults i n  a  dif f er e nt  m e di c al  d e vi c e r es p o ns e t h a n i nt e n d e d b y   m a n uf a ct ur er  or 
e x p e ct e d  b y   us er; t his i n cl u d es sli ps, l a ps es,  a n d  mist a k es. A n  u n e x p e ct e d  p h y si ol o gi c al 
r es p o ns e  of t h e s u bj e ct  d o es  n ot i n its elf  c o nstit ut e  a  us e  err or.
A  d e vi c e  d efi ci e n c y   m a y  or  m a y  n ot  b e  ass o ci at e d  wit h s u bj e ct h ar m (i e,  A D E  or  S A D E); 
h o w e v er ,  n ot  all A D Es  or  S A D Es  ar e  d u e t o  a  d e vi c e  d efi ci e n c y .  T h e I n v esti g at or m ust
d et er mi n e t h e  a p pli c a bl e  c at e g or y  f or t h e i d e ntifi e d  or s us p e ct  d e vi c e  d efi ci e n c y  a n d r e p ort 
a n y  s u bj e ct h ar m s e p ar at el y.  E x a m pl es  of  d e vi c e  d efi ci e n ci es i n cl u d e t h e f oll o wi n g:

P a g e  4 0 of  5 4
 
F ail ur e t o  m e et  pr o d u ct s p e cifi c ati o ns ( e g, i n c orr e ct I O L  p o w er,)
 
I OL  d ef e ct
 
Br o k e n  I OL   o pti c
 
Br o k e n  I OL  h a pti c
 
S cr at c h e d  I OL  o pti c
 
U ns e al e d  d e vi c e  p a c k a gi n g
 
L a c k  of  effi c a c y
 
A ut or efr a ct or  err ors  a n d  ot h er  di a g n osti c  e q ui p m e nt r el at e d  d efi ci e n ci es
1 2. 5 
R et u r n  P r o d u ct  A n al ysis
St u d y   S p o ns or r e pr es e nt ati v es  a n d t h eir  c o nt a ct i nf or m ati o n  ar e  pr o vi d e d i n t h e  M O P t h at 
a c c o m p a ni es t his  pr ot o c ol.
Al c o n  Pr o d u cts  ass o ci at e d  wit h  d e vi c e  d efi ci e n ci es  a n d/ or  pr o d u ct r el at e d  A Es  m ust b e 
r et ur n e d  as s p e cifi e d i n t h e  M O P  a n d  m ust i n cl u d e t h e  C o m pl ai nt  #  a n d  w hi c h  will  b e 
pr o vi d e d  b y t h e  S t u d y  S p o ns or.
1 2. 6 
M o nit o ri n g f o r  A d v e rs e  E v e nts
At  e a c h  visit,  aft er t h e s u bj e ct  h as  h a d t h e  o p p ort u nit y  t o s p o nt a n e o usly  m e nti o n  a n y 
pr o bl e ms, t h e I n v esti g at or  m ust i n q uir e  a bo ut  A Es  b y   as ki n g t h e st a n d ar d  q u esti o ns:
 
“ H a v e  y o u  h a d  a n y  h e alt h  pr o bl e ms si n c e  y o ur l ast st u d y   visit ? ”
 
“ H a v e t h er e  b e e n  a n y  c h a n g es i n t h e  m e di ci n es  y o u t a k e si n c e  y o ur l ast st u d y   visit ? ”
A Es  m ust b e r e p ort e d f or  a n y   cli ni c all y r el e v a nt  c h a n g e, i n t h e  o pi ni o n  of t h e I n v esti g at or, i n 
c o n c o mit a nt  m e di c ati o n(s) t h at is t h e r es ult  of  a n  u nt o w ar d ( u nf a v or a bl e  a n d  u ni nt e n d e d) 
c h a n g e  i n  a s u bj e ct's  m e di c al  h e alt h.
C h a n g es i n  a n y  pr ot o c ol -s p e cifi c  o c ul ar  o r sys t e mi c  p ar a m et er  e v al u at e d  d uri n g t h e st u d y  ar e 
t o  b e r e vi e w e d  by t h e I n v esti g at or . A n y  u nt o w ar d ( u nf a v or a bl e  a n d  u ni nt e n d e d)  c h a n g e i n  a 
pr ot o c ol -s p e cifi c  p ar a m et er  or  q u esti o n n air e r es p o ns e t h at is  cli ni c all y  r el e v a nt, i n t h e 
o pi ni o n  of t h e I n v esti g a t or, is t o  b e r e p ort e d  as  a n A E.  T h es e  cli ni c all y r el e v a nt  c h a n g es  will 
b e r e p ort e d r e g ar dl ess  of  c a us alit y . 
1 2. 7 
P r o c e d u r es f o r  R e c o r di n g  a n d  R e p o rti n g 
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
All  A Es  m ust  b e  d o c u m e nt e d  o n t h e  A E  el e ctr o ni c  c as e r e p ort f or m ( e C R F ) b y  t h e sit e  a n d 
ar e  m o nit or e d  o n  a r o uti n e  b asis  b y t h e  St u d y  S p o ns or. 

P a g e  4 1 of  5 4
A Es  ar e  c oll e ct e d fr o m t h e ti m e  of i nf or m e d  c o ns e nt.  A n y  pr e - e xisti n g  m e di c al  c o n diti o ns  or 
s ym pt o ms  pr es e nt i n  a s u bj e ct  ar e  n ot  c o nsi d er e d  A Es i n t h e st u d y . A q u e o us  c ells  a n d fl ar e, 
c or n e al  e d e m a, r ais e d I O P   a n d s u p erfi ci al  p u n ct at e  k er atitis  ar e  e x a m pl es  of  e arly 
p ost o p er ati v e fi n di n gs t h at  ar e t y pi c all y  o bs er v e d f oll o wi n g  o c ul ar s ur g er y . T h es e  ar e  n ot 
c o nsi d er e d A Es if t h e y   c a n  b e r e as o n a bly  e x p e ct e d t o r es ol v e  wit hi n  a  w e e k  a n d  n ot r es ult i n 
a n y   u nt o w ar d l o n g t er m vis u al  o ut c o m e i m p a ct.
T h e I n v esti g at or  m ust  pr o m ptl y   d o c u m e nt  all A D Es  a n d  S A Es  wit h  d et ails i n cl u di n g t h e  d at e 
of  o c c urr e n c e, s e v erit y , tr e at m e nt (if  a p pli c a bl e),  o ut c o m e,  a n d  ass ess m e nts  of t h e s eri o us n ess 
a n d  c a us alit y. In  a d diti o n, t h e I n v esti g at or  m u st  pr o m ptl y  d o c u m e nt  all  d e vi c e  d efi ci e n ci es  o n 
t h e D e vi c e  D efi ci e n c y e C R F.  T h e sit e  m ust s u b mit  all  a v ail a bl e i nf or m ati o n  o n  A D Es,  S A Es, 
a n d  d e vi c e  d efi ci e n ci es t o t h e  S t u d y  S p o ns or i m m e di at ely  as f oll o ws:
 
A D Es  o r  S A Es  a r e  d o c u m e nt e d  o n t h e  A d v ers e  D e vi c e Eff e ct  a n d  S eri o us  A d v ers e 
E v e nt  e C R F  wit hi n  2 4  h o u rs  of t h e I n v esti g at o r’s  o r sit e’s  a w a r e n ess. 
 
D e vi c e  d efi ci e n ci es  a r e  d o c u m e nt e d  o n t h e  D e vi c e  D efi ci e n c y  e C R F  wit hi n  2 4  h o u rs 
of t h e I n v esti g at o r’s  o r sit e’s  a w a r e n ess .  Pl e as e i n cl u d e  a  p ri nt e d  c o p y  of t h e 
c o m pl et e d  D e vi c e  D efi ci e n c y  e C R F wit h  p r o d u ct  r et u r ns. 
 
A d diti o n al  r el e v a nt i nf o r m ati o n  aft e r i niti al  r e p o rti n g is t o  b e  e nt e r e d i nt o t h e  e C R F 
as s o o n  as t h e  d at a  b e c o m e  a v ail a bl e. 
 
D o c u m e nt  a n y  c h a n g es t o  c o n c o mit a nt  m e di c ati o ns  o n t h e  a p p r o p ri at e  e C R Fs.
 
All  r el e v a nt  d o c u m e nt ati o n s u c h  as  Dis c h a r g e  S u m m a r y,  A ut o ps y  R e p o rt, 
C e rtifi c at e  of  D e at h  et c,  m ust b e f a x e d t o t h e  S t u d y  S p o ns o r  at 
N O T E: S h o ul d t h e  E D C s y st e m  b e c o m e  n o n -o p er ati o n al, t h e sit e  m ust  c o m pl et e t h e
a p pr o pri at e  p a p er  A d v ers e  D e vi c e  Eff e ct  a n d  S eri o us  A d v ers e  E v e nt  F or m or  D e vi c e 
D efi ci e n c y  F or m .  T h e  c o m pl et e d f or m is f a x e d t o t h e S t u d y  S p o ns or  at 
  wit hi n  2 4  h o urs  of t h e I n v esti g at or’s  or sit e’s  a w ar e n ess;  h o w e v er, t h e r e p ort e d 
i nf or m ati o n  m ust  b e  e nt er e d i nt o t h e  E D C s yst e m  o n c e it  b e c o m es  o p er ati o n al.
S p o ns o r   r e p res e nt ati v es  a n d t h ei r   c o nt a ct i nf o r m ati o n  a r e  p ro vi d e d i n t h e  M a n u al  of
P r o c e d u r es t h at  a c c o m p a ni es t his  p r ot o c ol .
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
F urt h er ,  d e p e n di n g  u p o n t h e  n at ur e  of t h e A E  or  d e vi c e  d efi ci e n c y   b ei n g r e p ort e d, t h e  St u d y 
S p o ns or  m a y  r e q u est  c o pi es  of  a p pli c a bl e  p orti o ns  of t h e s u bj e ct’s  m e di c al r e c or ds. T h e 
I n v esti g at or  m ust  als o r e p ort  all  A Es  a n d  d e vi c e  d efi ci e n ci es t h at  c o ul d  h a v e l e d t o  a  S A D E 
a c c or di n g t o t h e r e q uir e m e nts  of r e g ul at or y   a ut h oriti es  or IE C /IR B .

P a g e  4 2 of  5 4
1 2. 7. 1 
I nt e nsit y  a n d  C a us alit y Ass ess m e nts 
F or  e v er y   AE i n t h e st u d y , t h e I n v esti g at or  m ust  ass ess t h e  c a us ality ( R el at e d  or  N ot  R el at e d 
t o t h e cli ni c al i n v esti g ati o n. A n  ass ess m e nt  of  c a us alit y  will  als o  b e  p erf or m e d  b y   a S t u d y 
S p o ns or  p h y si ci a n  utili zi n g th e s a m e  d efi niti o ns,  as s h o w n  b el o w:
1 2. 7. 1. 1 
C a us alit y
R el at e d 
A n  A E  m a y   b e cl assifi e d  as  eit h er  d efi nit el y  r el at e d  or  p ossi bl y r el at e d t o t h e 
cli ni c al i n v esti g ati o n.  W h er e  a  dir e ct  c a us e  a n d  eff e ct r el ati o ns hi p  wit h t h e 
cli ni c al i n v esti g ati o n h as  n ot  b e e n  d e m o nstr at e d,  b ut t h er e is  a r e as o n a bl e 
p ossi bilit y  t h at t h e  A E  w as  c a us e d  by t h e  cli ni c al i n v esti g ati o n, t h e n  c a us alit y  
s h o ul d  b e  ass u m e d  u ntil it  c a n  b e  d e m o nstr at e d t h at t h e  A E is  n ot r el at e d t o 
t h e  cli ni c al i n v esti g ati o n.
N ot  R el at e d 
A n  A E  cl assifi e d  as  n ot r el at e d  m a y   eit h er  b e  d efi nit el y  u nr el at e d  or si m pl y 
u nli k el y  t o  b e r el at e d (i e, t h er e  ar e  ot h er  m or e li k el y  c a us es f or t h e  A E).
W h er e  a p pr o pri at e, t h e I n v esti g at or  m ust  ass ess t h e i nt e nsit y  (s e v erity)  of t h e  A E  as  mil d, 
m o d er at e,  or s e v er e  b as e d  o n  m e di c al j u d g m e nt  wit h  c o nsi d er ati o n  of  a n y s u bj e cti v e 
s ym pt o m(s),  as  d efi n e d  b el o w: 
1 2. 7. 1. 2 
I nt e nsit y ( S e v e rit y)
Mil d 
A n  A E is  mil d if t h e s u bj e ct is  a w ar e  of  b ut  c a n  e asil y t ol er at e t h e si g n  or 
s ym pt o m.
M o d e r at e 
A n  A E is  m o d er at e if t h e si g n  or s y m pt o m r es ults i n  dis c o mf ort si g nifi c a nt 
e n o u g h t o  c a us e i nt erf er e n c e  wit h t h e s u bj e ct’s  us u al  a cti viti es.
S e v e r e 
A n  A E is s e v er e if t h e si g n  or s y m pt o m is i n c a p a cit ati n g  a n d r es ults i n t h e 
s u bj e ct’s i n a bilit y t o  w or k  or  e n g a g e i n t h eir  us u al  a cti viti es.
1 2. 8 
U n m as k i n g  of t h e  St u d y I nf o r m ati o n
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
T his st u d y  is  n ot  m as k e d. H o w e v er t h e  e x a mi n er  p erf or mi n g  m a nif est r efr a cti o n is  m as k e d t o 
t h e r efr acti v e t ar g et  a n d r efr a cti v e  err or fr o m t h e s ur gi c al  pl a n ni n g  a n d t h e  o p er ati v e  visit .

P a g e  4 3 of  5 4
1 2. 9 
F oll o w -U p  of  S af et y I nf o r m ati o n
T h e I n v esti g at or is r es p o nsi bl e f or  a d e q u at e  a n d s af e  m e di c al  c ar e  of s u bj e cts  d uri n g t h e 
st u d y  a n d f or  e ns uri n g t h at  a p pr o pri at e  m e di c al  c ar e  a n d r el e v a nt f oll o w-u p  pr o c e d ur es  ar e 
m ai nt ai n e d  aft er t h e st u d y . T h e I n v esti g at or  m ust pr o vi d e t h e  S t u d y  S p o ns or  wit h  a n y  n e w 
s af et y i nf or m ati o n ( w hi c h i n cl u d es  n e w  A Es  a n d  c h a n g es t o  pr e vi o usl y  r e p ort e d A Es) t h at 
m a y   aff e ct t h e s af ety  e v al u ati o n  of t h e  d e vi c e.  A n y   a d diti o n al  d at a fr o m t h es e f oll o w- u p 
pr o c e d ur es p erf or m e d  u p t o  6  m o nt hs  aft er s u bj e ct  e xit  m ust  b e  d o c u m e nt e d  a n d  a v ail a bl e 
u p o n t h e  S t u d y  S p o ns or’s r e q u est. 
1 2. 1 0 
P r e g n a n c y i n t h e  Cli ni c al  St u d y 
If  a  w o m a n  b e c o m es  pr e g n a nt  d uri n g t h e st u dy,  t his i nf or m ati o n m ust b e  d o c u m e nt e d  b y  
M e di c al  S af et y i n t h e  a p pr o pri at e  d o c u m e nt ati o n .  Pr e g n a n c y is  n ot r e p ort a bl e  as  a n A E; 
h o w e v er ,  c o m pli c ati o ns  m a y  b e r e p ort a bl e  a n d  will  b e  d e ci d e d  o n  a  c as e- b y- c as e  b asis. A n 
Al c o n  pr e p ar e d f or m  will  b e  utili z e d t o  c a pt ur e  all  pr e g n a n c y- r el at e d i nf or m ati o n  u ntil  birt h 
of t h e  c hil d.
1 3 
A N A L Y SI S  P L A N
1 3. 1 
S u bj e ct  E v al u a bilit y
T h e fi n al s u bj e ct  e v al u a bilit y   will  b e  d et er mi n e d  pri or t o l o c ki n g t h e  d at a b as e.
1 3. 2   
A n al ysis  D at a  S ets
1 3. 2. 1 
S af et y  A n al ysis  S et
All s u bj e cts  wit h  att e m pt e d I O L  i m pl a nt ati o n (s u c c essf ul  or  a b ort e d  aft er  c o nt a ct  wit h t h e 
e y e) i n  at l e ast  o n e  e y e  will  b e  c o nsi d er e d  e v al u a bl e  a n d i n cl u d e d i n t h e s af et y   a n alys is s et. 
T h e s af et y  a n al ys is s et  will  b e  us e d f or t h e s af ety  a n al ys es. A d diti o n all y ,  a n y A E e x p eri e n c e d 
b y   a s u bj e ct  d uri n g t h e s cr e e ni n g  p eri o d  will  b e  pr es e nt e d s e p ar at ely i n t h e s af et y  a n al ysis.
1 3. 2. 2 
All I m pl a nt e d  A n al ysis  S et ( A A S)
All s u bj e cts  wit h s u c c essf ul I O L  i m pl a nt ati o n i n t h e st u d y e y e  will  b e i n cl u d e d i n t h e A A S. 
T h e  pri m ar y   a n alys is s et f or t h e  pri m ar y  a n d  e x pl or at or y  a n al ys es  will  b e t h e A A S.
1 3. 2. 3 
B est  C as e  A n al ysis  S et ( B A S)
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
B A S  will i n cl u d e t h e s u bj e cts i n  A A S  wit h t h e  e y e  wi t h t h e I O L  w hi c h  h a d 

P a g e  4 4 of  5 4
 
at l e ast  1  p ost o p er ati v e  visit,
 
n o  m a c ul ar  d e g e n er ati o n  at  a n y  ti m e;  a n d
 
n o  m aj or  pr ot o c ol  vi ol ati o n
T h e  B A S is  a s u p p orti v e  a n al ys is s et f or t h e  pri m ar y  a n d  e x pl or at or y  a n alys es.
1 3. 3 
D e m o g r a p hi cs  a n d  B as eli n e  C h a r a ct e risti cs
D e m o gr a p hi c  a n d  b as eli n e  c h ar a ct eristi cs  will  b e s u m m ari z e d  usi n g fr e q u e n c y   distri b uti o ns 
f or  c at e g ori c al  p ar a m et ers  a n d  d es cri pti v e st atisti cs ( n u m b er,  m e a n, st a n d ar d  d e vi ati o n, a n d 
m e di a n ,  mi ni m u m,  m a xi m u m) f or  c o nti n u o us  p ar a m et ers.  D e m o gr a p hi c  c h ar a ct eristi cs  will 
i n cl u d e  a g e,  g e n d er, r a c e  a n d  et h ni cit y.  
D e m o gr a p hi cs  a n d  b as eli n e  c h ar a ct eristi cs s u m m ari es  will  b e  pr es e nt e d f or t h e  A A S f or 
o v er all  a n d  b y sit e. 
1 3. 4 
Eff e cti v e n ess A n al ys es
1 3. 4. 1 
P ri m a r y  Eff e cti v e n ess
T h e  pri m ar y   o bj e cti v e  of t his st u d y is t o  d e m o nstr at e  e q ui v al e n c y  at  e a c h  of t h e  3  cli ni c al 
sit es,  b et w e e n I O L  S R K/ T  A- co nst a nt  esti m at e d  b as e d  o n  p ost o p er ati v e  m a nif est s p h eri c al 
e q ui v al e nt r efr a cti o n  at  3  m o nt hs  a n d I O L   S R K/ T  A- co nst a nt  esti m at e d  b as e d  o n 
p ost o p er a ti v e s p h eri c al  e q ui v al e nt fr o m  aut or efr a cti o n usi n g  T o p c o n K R - 1 W at  3  m o nt hs.  T h e 
pri m ar y   e n d p oi nts t o  b e  us e d f or t h e  pri m ar y  a n al ysis  ar e:
 
I OL  S R K/ T   A-c o ns t a nt  esti m at e d  b as e d  o n t h e  pr eo p er ati v e  bi o m etr y , I O L  p o w er  a n d 
p ost o p er ati v e  m a nif est s p h eri c al  e q ui v al e nt r efr a cti o n  at  3  m o nt hs  a n d
 
I OL  S R K/ T   A-c o nst a nt  esti m at e d  b as e d  o n t h e  pr e o p er ati v e  bi o m etr y , I O L  p o w er  a n d 
p ost o p er ati v e s p h eri c al  e q ui v al e nt fr o m  a ut or efr a cti o n  usi n g  T o p c o n K R - 1 W
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
at 
3 m o nt hs. 
T h e  pri m ar y   a n alys is  d at a s et  will  b e t h e A A S.

P a g e  4 5 of  5 4
1 3. 4. 1. 1 
St atisti c al  H y p ot h es es
T h e  n ull  a n d  a lt er n ati v e  h yp ot h es es f or t h e  pri m ar y  a n al ys is  ar e:
  :  μ(   ) ≤   − 0. 1 5      μ(   ) ≥  0. 1 5  
  :   − 0.1 5 <   (   ) <   0. 1 5
W h er e  μ (   )  r ef ers t o t h e  m e a n  diff er e n c e  b et w e e n t h e  e n d p oi nts list e d i n  S e cti o n  1 3. 4. 1 
f or  e a c h sit e.  T his  hy p ot h esis  will  b e  ass ess e d s e p ar at el y f or  e a c h sit e wit h  a  p air e d t- t est.
1 3. 4. 1. 2 
A n al ysis  M et h o ds
T w o- si d e d  9 0 %  c o nfi d e n c e i nt er v al  will  b e  c o nstr u ct e d f or t h e  m e a n  of t h e  p air e d  dif f er e n c e 
b et w e e n t h e t w o  esti m at e d  S R K/ T   A-c o nst a nts s e p ar at el y f or  e a c h sit e. If t h e t w o -si d e d  9 0 % 
c o nfi d e n c e i nt er v al f all  wit hi n (- 0. 1 5,  0. 1 5), t h e n  e q ui v al e n c e  will  b e  c o n cl u d e d.
D es cri pti v e st atisti cs ( m e a n,  m e di a n, st a n d ar d  d e vi ati o n,  n u m b er  of  e y es,  mi ni m u m, 
m a xi m u m,  a n d  t w o-si d e d  9 0 %  c o nfi d e n c e i nt er v al)  will  b e  pr o vi d e d f or  e a c h sit e f or t h e 
eff e cti v e n ess  e n d p oi nts  a n d  als o f or t h e  dif f er e n c e. 
1 3. 4. 2 
S e c o n d a r y  Eff e cti v e n ess
T h er e  ar e  n o s e c o n d ar y  eff e cti v e n ess  a n al ys es i n t his st u d y.
1 3. 4. 2. 1 
St atisti c al  H y p ot h es es
N ot  A p pli c a bl e
1 3. 4. 2. 2 
A n al ysis  M et h o ds
N ot  A p pli c a bl e
1 3. 4. 3

A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
 
 
 
 

P a g e  4 8 of  5 4
1 3. 7 
S af et y  A n al ysis
T h e s af et y  a n al ys es  will i n cl u d e t h e f oll o wi n g s af et y   ass ess m e nts:
 
A d v ers e  e v e nt s i n cl u di n g  S SIs
 
Slit -la m p  e x a m i n ati o n
 
Dil at e d  fu n d us  e x a m i n ati o n
 
S ur gi c al p r o bl e ms
 
S u bj e ct i v e P C O
 
P C
 
I OL  o bs er v ati o ns
 
I OL  p ositi o n  c h a n g e
 
I O P
 
D e vi c e  d efi ci e n ci es
D es cri pti v e st atisti cs  g e n er at e d f or s af et y  p ar a m et ers  will  b e  b as e d  u p o n t h e t y p e  of 
p ar a m et er (i e,  w h et h er t h e  d at a  ar e  c at e g ori c al  or  c o nti n u o us)  b ei n g  a n al y z e d.  F or  c at e g ori c al 
p ar a m et ers, t h e st atisti cs  us e d t o s u m m ari z e t h e  d at a  will i n cl u d e s a m pl e si z e,  n u m b er i n t h e 
c at e g or y,  a n d  p er c e nt i n t h e  c at e g or y.  F or  c o nti n u o us  p ar a m et ers, s a m pl e si z e,  m e a n,  m e di a n, 
st a n d ar d  d e vi ati o n,  mi ni m u m,  a n d  m a xi m u m  will  b e  pr es e nt e d
1 3. 8 
I nt e ri m A n al y s es
N o f or m al i nt eri m  a n al ys es  ar e  pl a n n e d.
1 3. 9 
A d a pti v e  St u d y  D esi g n
N o  a d a pt ati o ns  ar e  pl a n n e d i n t his st u d y .
1 3. 1 0 
S a m pl e  Si z e  J ustifi c ati o n
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
A  mi ni m u m  of  1 6 5 s u bj e cts  will  b e  e nr oll e d t o  e ns ur e  at l e ast  1 4 4  e v al u a bl e s u bj e cts 
( 4 8 e v al u a bl e s u bj e cts  p er sit e)  c o m p l et e t h e st u d y. 
Wi t h  4 8  e v al u a bl e s u bj e cts  p er sit e, st u d y  h as  9 0 %  c h a n c e t o s h o w t h at t h e  m e a n  diff er e n c e 
i n IO L   A-c o nst a nts  c al c ul at e d  wit h  p ost o p er ati v e m a nif est s p h eri c al  e q ui v al e nt r efr a cti o n  at 
3 m o nt hs  a n d  p ost o p er ati v e s p h eri c al  e q ui v al e nt fr o m  a ut or efr a cti o n  at  3  m o nt hs is  wit hi n t h e 

P a g e  4 9 of  5 4
e q ui v al e n c e  m ar gi n  of  ± 0. 1 5 f or  e a c h sit e  ass u mi n g t h at t h e  m e a n  a n d t h e st a n d ar d  d e vi ati o n 
( S D)  of  a  p air e d  diff er e n c e  ar e  0  a n d  0. 3 5 r es p e cti v el y. 
T h e  S D  of  0. 3 5 is  b as e d  o n t h e  S D  of t h e  dif f er e n c e i n t h e  esti m at e d A- c o nst a nt  b et w e e n t h e 
first  a n d t h e s e c o n d  e yes i n s u bj e cts i m pl a nt e d  wit h  A C R Y S O F I Q  M o n of o c al I O L   
 
(A C R Y S O F I Q  R e S T O R  M ultif o c al  + 2. 5 D).
1 4 
D A T A   H A N D LI N G A N D  A D MI NI S T R A TI V E 
R E Q UI R E M E N T S
1 4. 1 
S u bj e ct  C o nfi d e nti a lit y
T h e I n v esti g at or  m ust  e ns ur e t h at t h e s u bj e ct’ s  a n o n ymit y  is  m ai nt ai n e d t hr o u g h o ut t h e 
c o urs e  of t h e st u d y.  In  p arti c ul ar , t h e I n v esti g at or  m ust  k e e p  a n  e nr oll m e nt l o g  wit h 
c o nfi d e nti al i d e ntif y i n g i nf or m ati o n t h at  c orr es p o n ds t o t h e s u bj e ct  n u m b ers  an d i niti als  of 
e a c h st u d y  p arti ci p a nt.  At t h e  e n d  of t h e  cli ni c al st u d y , t h e  St u d y  S p o ns or  will  c oll e ct  a  c o p y 
of t h e  e nr oll m e nt l o g  wit h o ut  a n y i d e ntif yi n g s u bj e ct i nf o r m ati o n
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
.  All  d o c u m e nts 
s u b mitt e d t o t h e  St u d y  S p o ns or  will i d e ntif y t h e s u bj e cts  e x cl usi v el y  b y  n u m b er  a n d 
d e m o gr a p hi c i nf or m ati o n.  N o  ot h er  p ers o n all y  i d e ntif yi n g i nf or m ati o n  will  b e tr a ns mitt e d t o 
t h e  St u d y  S p o ns or.
T h e  St u d y   S p o ns or  m a y r el e as e  a n o n ymi z e d st u d y  d at a t o  e xt er n al r es e ar c h ers f or  p ur p os es 
of f ut ur e r es e ar c h  dir e ctl y  r el at e d t o t h e st u d y  o bj e cti v es,  or f ut ur e r es e ar c h t h at is  b e yo n d t h e 
s c o p e  of t h e  c urr e nt st u d y  o bj e cti v es.  T h e  I CF e x pl ai ns t his t o st u d y  s u bj e cts. A n o n y m i z ati o n 
m e a ns t h at  all i d e ntifi a bl e i nf or m ati o n  will  b e r e m o v e d fr o m t h e  d at as et  a n d  all li n ks t o t h e 
s u bj ects i n t h e st u d y   will  b e r e m o v e d. A n o n y m i z ati o n  of t h e  d at a  will  m ai nt ai n 
c o nfi d e nti alit y   of t h e s u bj e cts  w h o  p arti ci p at e i n t h e st u d y s o t h at t h e y  c a n n ot  b e i d e ntifi e d  b y 
e xt er n al r es e ar c h ers.  T h e  a n o n y mi z e d  d at a s et  will  c o nt ai n r e c or ds fr o m  all  of t h e s u bj e cts i n 
t h e  c urr e nt st u d y,  b ut t h e  a n o n ymi z ati o n  pr o c ess  mi g ht  c h a n g e t h e  d at a s et i n s o m e  w a y s, s o 
e xt er n al r es e ar c h ers  will  b e i nf or m e d t h at t h e y   mi g ht  n ot  b e  a bl e t o  d u pli c at e s o m e  of t h e 
r es ults fr o m t his st u d y.  
E xt er n al r es e ar c h ers  w h o r e q u est  p e r missi o n t o  us e  a n o n ymi z e d  d at a fr o m st u di es f or  a  n e w 
m e di ci n e  or  n e w i n di c ati o n  of  a  m e di ci n e (st u di es f or  a p pr o v e d  m e di ci n al  pr o d u cts, s m all 
m ol e c ul e  g e n eri cs,  a n d  d e vi c es  ar e  e x cl u d e d)  m ust  b e  a p pr o v e d  b y  a  c e ntr al i n d e p e n d e nt 
r e vi e w  p a n el t h at  will  a dj u di c at e t h e s ci e ntifi c r e q u est  a n d t h e  c o m p et e n c y  of t h e  e xt er n al 
r es e ar c h er(s),  as  w ell  as t h e  d et er mi n e  a p pli c a bilit y t o  c urr e nt st a n d ar d  o p er ati n g  pr o c e d ur es 
(S O Ps ). If  a p pr o v e d,  a  d at a s h ari n g  a gr e e m e nt  will  b e  e x e c ut e d  b et w e e n t h e  St u d y  S p o ns or 
a n d t h e  e xt er n al r es e ar c h er(s),  c o m mitti n g t o  a s p e cifi e d  a n al ys is  a n d  p u bli c ati o n ti m eli n e. 

P a g e  5 0 of  5 4
A n o n y mi z e d  d at a  will  b e r el e as e d t o  e xt er n al r es e ar c h ers  o nl y   aft er  E U  a n d/ or  U S 
s u b missi o n  of t h e i n v esti g ati o n al  dr u g/ bi ol o gi c f or t h e st u d y  i n di c ati o n. T h e  St u d y  S p o ns or 
will  n ot  b e  a bl e t o i nfl u e n c e t h e  a n al ys es t h at  ar e  p erf or m e d  b y  e xt er n al r es e ar c h ers  usi n g t h e 
d at a fr o m t his st u d y   o n c e t h e a n o n y m i z e d  d at a  ar e r el e as e d.
1 4. 2 
C o m pl eti o n  of  S o u r c e  D o c u m e nts  a n d  C as e  R e p o rt  F o r ms
T h e  n at ur e  a n d l o c ati o n  of  all s o ur c e  d o c u m e nts  will  b e i d e ntifi e d t o  e ns ur e t h at  ori gi n al  d at a 
r e q uir e d t o  c o m pl et e t h e e C R F s e xist  a n d  ar e  a c c essi bl e f or  v erifi c ati o n  b y  t h e sit e  m o nit or, 
a n d  all  dis cr e p a n ci es  m ust b e  a p pr o pri at el y  d o c u m e nt e d  vi a t h e  q u er y  r es ol uti o n  pr o c ess. 
St u d y   m o nit ors  ar e a p p oi nt e d  b y  t h e  St u d y  S p o ns or  a n d  ar e i nd e p e n d e nt  of st u d y  sit e st aff.
If  el e ctr o ni c r e c or ds  ar e  m ai nt ai n e d, t h e  m et h o d  of  v erifi c ati o n  m ust  b e  d et er mi n e d i n
a d v a n c e  of st arti n g t h e st u d y. 
At  a  mi ni m u m, s o ur c e  d o c u m e nts i n cl u d e t h e f oll o wi n g i nf or m ati o n  f or  e a c h s u bj e ct:
 
S u bj e ct i d e ntifi c ati o n ( n a m e, s e x, r a c e/ et h ni cit y)
 
D o c u m e nt ati o n  of s u bj e ct  eli gi bilit y
 
D at e  of i nf or m e d  c o ns e nt
 
D at es  of  visits
 
D o c u m e nt ati o n t h at  pr ot o c ol s p e cifi c  pr o c e d ur es  w er e  p erf or m e d
 
R es ults  of st u d y   p ar a m et ers,  as r e q uir e d  by t h e  pr ot o c ol
 
I P a c c o u nt a bilit y  r e c or ds
 
D o c u m e nt ati o n  of  A Es  a n d  ot h er s af et y  p ar a m et ers (if  a p pli c a bl e)
 
R e c or ds r e g ar di n g  m e di c al  hist ori es  a n d t h e  us e  of  c o n c o mit a nt t h er a pi es  pri or t o  a n d 
d uri n g t h e st u d y

A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
D at e  of  st u d y c o m pl eti o n  a n d r e as o n f or  e arl y  dis c o nti n u ati o n, if  a p pli c a bl e
It is r e q uir e d t h at t h e  a ut h or  of  a n  e ntr y i n t h e s o ur c e  d o c u m e nts  b e i d e ntifi a bl e.  Dir e ct  a c c ess 
t o s o ur c e  d o c u m e nt ati o n ( m e di c al r e c or ds)  m ust  b e  all o w e d f or t h e  p ur p os e  of  v erif yi n g t h at 
t h e  d at a r e c or d e d  o n t h e e C R F  ar e  c o nsist e nt  wit h t h e  ori gi n al s o ur c e  d at a.
O nl y d esi g n at e d i n di vi d u als at t h e sit e  will c o m pl et e t h e  e C R Fs.  T h e  e C R Fs  m ust b e 
c o m pl et e d at r e g ul ar i nt er v als f oll o wi n g t h e  cli ni c al st u d y visi t s c h e d ul e. It is  e x p e ct e d t h at 
all  d at a r e p ort e d  h a v e  c orr es p o n di n g  e ntri es i n t h e s o ur c e  d o c u m e nts.   T h e  Pri n ci p al 
I n v esti g at or is r es p o nsi bl e f or r e vi e wi n g a n d  c ertif y i n g t h at t h e e C R Fs  ar e  a c c ur a t e  a n d 
c o m pl et e.  T h e  o nl y  s u bj e ct i d e ntifi ers  r e c or d e d  o n t h e e C R Fs  will b e s u bj e ct  n u m b er ,  a n d 
s u bj e ct d e m o gr a p h i c i nf or m ati o n. 

P a g e  5 1 of  5 4
1 4. 3 
D at a  R e vi e w  a n d  Cl a rifi c ati o ns
A  t ar g et e d r e vi e w  of e C R F  d at a t o t h e s u bj e ct’ s s o ur c e  d at a  will  b e  c o m pl et e d  b y t h e sit e 
m o nit or t o  e ns ur e  c o m pl et e n ess  a n d  a c c ur a c y.  Aft er t h e  e C R Fs  h a v e  b e e n  c o m pl et e d , 
a d diti o n al  d at a  cl arifi c ati o ns  a n d/ o r  a d diti o ns  m a y  b e  n e e d e d  as  a r es ult  of t h e  d at a  cl e a ni n g 
pr o c ess.  D at a  cl arifi c ati o ns  ar e  d o c u m e nt e d  a n d  ar e  p art  of  e a c h s u bj e ct’ s e C R F . 
1 4. 4 
S p o ns o r  a n d  M o nit o ri n g  R es p o nsi biliti es
T h e  St u d y   S p o ns or will  d esi g n at e  a  m o nit or t o  c o n d u ct t h e  a p pr o pri at e sit e  visits  at t h e 
a p pr o pri at e i nt er v als.  T h e  cli ni c al i n v esti g ati o n  will  b e  m o nit or e d t o  e ns ur e t h at t h e ri g hts 
a n d  w ell -b ei n g  of t h e s u bj e cts  ar e  pr ot e ct e d, t h e r e p ort e d  d at a  ar e  a c c ur at e,  c o m pl et e,  a n d 
v erifi a bl e fr o m t h e s o ur c e  d o c u m e nts,  a n d t h e st u d y  is  co n d u ct e d i n  c o m pli a n c e  wit h t h e 
c urr e nt  a p pr o v e d  pr ot o c ol ( a n d  a m e n d m e nts[s], if  a p pli c a bl e),  wit h  c urr e nt  G C P,  a n d  wit h 
a p pli c a bl e r e g ul at or y  r e q uir e m e nts.
All sit es  m ust h a v e  a sit e i niti ati o n.  Pri or t o s cr e e ni n g s u bj e cts  or  p erf or mi n g t h e i nf or m e d 
c o ns e nt  pr o c ess  o n  a n y s u bj e ct, t h e sit e  m ust r e c ei v e  a  Sit e  A cti v ati o n  N otifi c ati o n fr o m  a n 
a p pr o pri at e  St u d y  S p o ns or r e pr es e nt ati v e.  M o nit ori n g  will  b e  c o n d u ct e d  p eri o di c all y   w hil e 
t h e  cli ni c al st u d y is  o n g oi n g.  M o nit ori n g  m et h o ds  m a y i n cl u d e sit e  visits, t ele p h o n e,  writt e n 
a n d f a x  c orr es p o n d e n c e.  Cl os e -o ut  visits  will t a k e  pl a c e  aft er t h e l ast  visit  of t h e l ast  s u bj e ct 
or  aft er  d at a b as e l o c k .
A  C o or di n ati n g  I n v esti g at or ( CI) m a y   b e i d e ntifi e d  b y t h e St u d y   S p o ns or. I n  c as es  w h er e  a CI
is r e q uir e d, t h e St u d y   S po ns or will s el e ct t h e  CI b as e d  u p o n t h eir  e x p eri e n c e,  q u alifi c ati o ns, 
a cti v e st u d y   p arti ci p ati o n,  a n d t h eir  willi n g n ess  a n d  a v ail a bilit y t o t a k e  o n t his r ol e. T h e  CI
will  b e  b o u n d  b y   c o nfi d e nti alit y  o bli g ati o ns  d es cri b e d i n  a s e p ar at e  c o nfi d e nti alit y  a gr e em e nt 
b et w e e n t h e  CI a n d t h e  St u d y   S p o ns or.
A d diti o n all y , a St u d y   S p o ns or r e pr es e nt ati v e  will  pr o vi d e tr ai ni n g  o n  pr o p er  o p er ati o n  of t h e 
T o p c o n K R -1 W  W a v efr o nt A n al y z er a n d  ot h er st u d y   ass ess m e nts as  a p pr o pri at e .  D et ail e d 
i nstr u cti o ns  ar e  c o v er e d i n t h e  M O P. A  c o p y  of  c oll e ct e d i m a g es  f or m st u d y  ass ess m e nts m a y  
b e s e nt  el e ctr o ni c all y t o t h e  S p o ns or .  T h es e i m a g es  m ust  b e  m as k e d t o s u bj e ct i d e ntifi c ati o n 
i nf or m ati o n.
1 4. 5 
R e g ul at o r y  D o c u m e nt ati o n  a n d  R e c o r ds  R et e nti o n
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
T h e I n v esti g at or is r e q uir e d t o  m ai nt ai n  u p -t o-d at e,  c o m pl et e r e g ul at or y   d o c u m e nt ati o n  as 
i n di c at e d  by t h e  St u d y  S p o ns or  a n d t h e I n v esti g at or ’s fil es  will  b e r e vi e w e d  as  p art  of t h e 

P a g e  5 2 of  5 4
o n g oi n g st u d y  m o nit ori n g.  Fi n a n ci al i nf or m ati o n is  n ot s u bj e ct t o r e g ul at or y  i ns p e cti o n  a n d is 
t o  b e  k e pt s e p ar at el y. 
A d diti o n all y , t h e I n v esti g at or  m ust  k e e p st u d y r e c or ds  a n d s o ur c e  d o c u m e nts  u ntil t h e  St u d y 
S p o ns or  pr o vi d es  writt e n  a p pr o v al f or t h eir  d estr u cti o n. If t h e I n v esti g at or r etir es, r el o c at es, 
or f or  a n y  ot h er r e as o n wit h dr a ws fr o m r es p o nsi bilit y   of  k e e pi n g t h e st u d y r e c or ds, t h e n t h e 
St u d y   S p o ns or  m ust  b e  n otifi e d  a n d s uit a bl e  arr a n g e m e nts  m a d e f or r et e nti o n  of st u d y 
r e c or ds  a n d s o ur c e  d o c u m e nts  n e e d e d t o  c o m ply  wit h  n ati o n al  a n d i nt er n ati o n al r e g ul ati o ns 
( g e n er all y 2  y e ars  aft er  dis c o nti n ui n g  cli ni c al  d e v el o p m e nt  or  aft er t h e  l ast m ar k eti n g 
a p pr o v al).
1 4. 6 
Q u alit y  Ass u r a n c e  a n d  Q u alit y  C o nt r ol
T h e  St u d y   S p o ns or will s e c ur e  a gr e e m e nt fr o m  all i n v ol v e d  p arti es t o  e ns ur e  dir e ct  a c c ess t o 
all st u d y  r el at e d sit es, s o ur c e  d at a  a n d  d o c u m e nts,  a n d r e p orts f or t h e  p ur p os e  of  m o nit ori n g 
a n d  a u diti n g  b y t h e  St u d y   S p o ns or,  a n d i ns p e cti o n  b y  d o m esti c  a n d f or ei g n r e g ul at or y 
a ut h oriti es.  Q u alit y   c o ntr ol  will  b e  a p pli e d t o  e a c h st a g e  of  d at a  h a n dli n g t o  e ns ur e t h at  all 
d at a  ar e r eli a bl e  a n d  h a v e  b e e n  pr o c ess e d  c orr e ctl y . A gr e e m e nts  m a d e  b y t h e  St u d y   S p o ns or
wit h t h e I n v esti g at or/I nstit uti o n  a n d  a n y   ot h er  p arti es i n v ol v e d i n t h e  cli ni c al st u d y  will  b e 
pr o vi d e d i n  writi n g  as  p art  of t h e  pr ot o c ol  or  as  a s e p ar at e  a gr e e m e nt.
1 5 
E T HI C S
T his  cli ni c al st u d y  m ust b e  c o n d u ct e d i n  a c c or d a n c e  wit h t h e  et hi c al  pri n ci pl es c o nt ai n e d 
wit hi n:
 
T h e  D e cl ar ati o n  of  H elsi n ki ( D o H ), a n d i n  c o m pli a n c e  wit h t h e I nt er n ati o n al 
C o nf er e n c e  o n  H ar m o ni z ati o n ( I CH) E 6  G C P  C o ns oli d at e d  G ui d eli n e
 
I S O  1 4 1 5 5: 2 0 1 1  Cli ni c al i n vesti g ati o n  of  m e di c al  d e vi c es f or  h u m a n s u bj e cts  – G o o d 
cli ni c al  pr a cti c e

A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
S O Ps  of  t h e  St u d y  S p o ns or a n d  c o ntr a ct r es e ar c h  or g a ni z ati o ns  p arti ci p ati n g i n t h e 
c o n d u ct  of t h e  cli ni c al  st u d y a n d  all  ot h er  a p pli c a bl e r e g ul ati o ns. 
T h e I n v esti g at or  a n d  all  cli ni c al st u d y  st aff m ust c o n d u ct t h e  cli ni c al st u d y  i n  c o m pli a n c e 
wit h t h e  pr ot o c ol.  T h e I n v esti g at or  m ust e ns ur e t h at  all  p ers o n n el i n v ol v e d i n t h e  c o n d u ct  of 
t h e st u d y  ar e  q u alifi e d t o  p erf or m t h eir  assi g n e d r es p o nsi biliti es t hr o u g h r el e v a nt  e d u c ati o n, 
tr ai ni n g,  a n d  e x p eri e n c e.
B ef or e  cli ni c al st u d y  i niti ati o n, t his  pr ot o c ol, t h e I C F,  a ny  ot h er  writt e n i nf or m ati o n  gi v e n t o 
s u bj e cts,  a n d  a n y  a d v ertis e m e nts  pl a n n e d f or s u bj e ct r e cr uit m e nt  m ust  b e  a p pr o v e d  b y  a n 

P a g e  5 3 of  5 4
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
I E C/I R B.  T h e I n v esti g at or  m ust  pr o vi d e  d o c u m e nt ati o n  of t h e I E C/IR B  a p pr o v al t o t h e  St u d y  
S p o ns or .  T h e  a p pr o v al  m ust  b e  d at e d  a n d  m ust i d e ntif y t h e  a p pli c a bl e  pr ot o c ol,  a m e n d m e nts 
(if  a ny),  I CF,  all  a p pli c a bl e r e cr uiti n g  m at eri als,  writt e n i nf or m ati o n f or s u bj e ct,  a n d s u bj e ct 
c o m p e ns ati o n  pr o gr a ms.  T h e I E C/I R B  m ust  b e  pr o vi d e d  wit h  a  c o p y   of t h e a n y   p eri o di c 
s af et y  u p d at es,  a n d  all  ot h er i nf or m ati o n  as r e q uir e d  b y l o c al r e g ul ati o n  a n d/ or t h e I E C/I R B. 
At t h e  e n d  of t h e st u d y, t h e I n v esti g at or  m ust n otif y  t h e I E C/IR B  a b o ut t h e st u d y ’s 
c o m pl eti o n.  T h e I E C/I R B  als o  m ust b e  n otifi e d if t h e st u d y  is t er mi n at e d  pr e m at ur ely.  
Fi n all y , t h e I n v esti g at or m ust r e p ort t o t h e I E C/IR B  o n t h e  pr o gr ess  of t h e st u d y   at i nt er v als 
sti p ul at e d  b y t h e I E C/I R B.
Vo l u nt ar y i nf or m e d  c ons e nt  m ust b e  o bt ai n e d fr o m  e v er y  s u bj e ct  pri or t o t h e i niti ati o n  of  a n y 
s cr e e ni n g  or  ot h er st u d y- r el at e d  pr o c e d ur es.  T h e I n v esti g at or  m ust  h a v e  a  d efi n e d  pr o c ess f or 
o bt ai ni n g  c o ns e nt.  S p e cifi c all y , t h e I n v esti g at or,  or d el e g at e , m ust e x pl ai n t h e  cli ni c al st u d y 
t o  e a c h  p ot e nti al s u bj e ct  a n d t h e s u bj e ct  m ust i n di c at e  v ol u nt ar y  c o ns e nt  b y si g ni n g  a n d 
d ati n g t h e  a p pr o v e d  I CF .  T h e s u bj e ct  m ust  b e  pr o vi d e d  a n  o p p ort u nit y t o  as k  q u esti o ns  of t h e 
I n v esti g at or,  a n d if r e q uir e d  b y l o c al r e g ul ati o n,  ot h er  q u alifi e d p ers o n n el.  T h e I n v esti g at or 
m ust  pr o vi d e t h e s u bj e ct  wit h  a  c o p y  of t h e  c o ns e nt f or m  writt e n i n  a l a n g u a g e t h e s u bj e ct 
u n d erst a n ds.  T h e  c o ns e nt  d o c u m e nt  m ust  m e et  all  a p pli c a bl e l o c al l a ws  a n d  pr o vi d e s u bj e cts 
wit h i nf or m ati o n r e g ar di n g t h e  p ur p os e,  pr o c e d ur es, r e q uir e m e nts,  a n d r estri cti o ns  of t h e 
st u d y,  al o n g  wit h  a n y  k n o w n ris ks  a n d  p ot e nti al  b e n efits  ass o ci at e d  wit h t h e I P, t h e  a v ail a bl e 
c o m p e ns ati o n,  a n d t h e  est a blis h e d  pr o visi o ns f or  m ai nt ai ni n g  c o nfi d e nti alit y   of  p ers o n al, 
pr ot e ct e d  h e alt h i nf or m ati o n.  S u bj e cts  will  b e t ol d  a b o ut t h e  v ol u nt ar y  n at ur e  of  p arti ci p ati o n 
i n t h e st u d y  a n d m ust b e  pr o vi d e d  wit h  c o nt a ct i nf or m ati o n f or t h e  a p pr o pri at e i n di vi d u als 
s h o ul d  q u esti o ns  or  c o n c er ns  aris e  d uri n g t h e st u d y. T h e s u bj e ct  als o  m ust b e t ol d t h at t h eir 
r ec or ds  m a y   b e  a c c ess e d  b y  a p pr o pri at e  a ut h oriti es  a n d  S p o ns or-d esi g n at e d  p ers o n n el.  T h e 
I n v esti g at or  m ust  k e e p t h e  ori gi n al, si g n e d  c o py  of t h e  c o ns e nt  a n d  m ust  pr o vi d e  a  d u pli c at e 
c o p y  t o  e a c h s u bj e ct a c c or di n g t o l o c al r e g ul ati o ns. 
T h e  St u d y   S p o ns or  ass ur es t h at t h e  k e y  d esi g n  el e m e nts  of t his  pr ot o c ol  will  b e r e gist er e d i n 
w w w . cli ni c altri als. g o v as r e q uir e d  b y  c urr e nt r e g ul ati o ns  a n d, if  a p pli c a bl e,  ot h er  p u bli c 
d at a b as es  as r e q uir e d  b y  l o c al  c o u ntr y r e g ul atio ns. I n  a d diti o n, r es ults  of t his st u d y   will  b e 
m a d e  p u bli cl y   a v ail a bl e i n w w w . cli ni c altri als. g o v r e g ar dl ess  of  o ut c o m e  as r e q uir e d  by 
c urr e nt r e g ul ati o ns  a n d, if  a p pli c a bl e, i n  ot h er  p u bli c  d at a b as es  as r e q uir e d  b y  l o c al  c o u ntr y 
r e g ul ati o ns.
A m e n d m e nts  m a y   n e c essit at e t h at t h e i nf or m e d  c o ns e nt  a n d  ot h er st u d y-r el at e d  m at eri al  b e 
r e vis e d. If t h e  c o ns e nt f or m is r e vis e d,  all s u bj e cts  c urr e ntly  e nr oll e d i n t h e st u d y  m ust si g n 
t h e  a p pr o v e d, r e vis e d i nf or m e d  c o ns e nt,  as r e q uir e d  b y t h e I E C/IR B . 

P a g e  5 4 of  5 4
1 6 
R E F E R E N C E S
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6
Arist o d e m o u  P ,  K n o x  C art wri g ht  N E,  S p arr o w J M, J o h nst o n  R L. Intr a o c ul ar l e ns f or m ul a 
c o nst a nt  o pti mi z ati o n  a n d  p arti al  c o h er e n c e i nt erf er o m etr y   bi o m etr y: refr a cti v e  o ut c o m es i n 
8 1 0 8  e y es  aft er  c at ar a ct s ur g er y. J C at ar a ct  R efr a ct  S ur g.  2 0 1 1; 3 7 ( 1): 5 0- 6 2.
B o ett n er E A, W olt er J R. Tr a ns missi o n of t h e o c u lar m e di a. I n vest O p ht h al m ol. 1 9 6 2; 1: 7 7 6 -
8 3.
G al e  R P ,  S al d a n a  M, J o h nst o n  R L,  Z u b er b u hl er  B,  M c Ki b bi n  M.  B e n c h m ar k st a n d ar ds f or 
r efr a cti v e  o ut c o m es  aft er  N H S  c at ar a ct s ur g er y.   E ye ( L o n d).  2 0 0 9; 2 3( 1), 1 4 9- 5 2.
I S O  1 4 1 5 5: 2 0 11  Cli ni c al i n v esti g ati o n  of  m e di c al  d e vi c es f or  h u m a n s u bj e cts  - G o o d  cli ni c al 
pr a cti c e.
S h e ar d  R.  O pti mis i n g  bi o m etr y f or  b est  o ut c o m es i n  c at ar a ct s ur g er y.  E ye ( L o n d). 
2 0 1 4; 2 8 ( 2):1 1 8- 2 5.
S n e d e c or G W,   Co c hr a n W G.  St atisti c al  M et h o ds.   Ei g ht h  E diti o n. A m es (I A):  I o w a  St at e 
U ni v ersit y   Pr ess;  1 9 8 9.

                                                                                                                
                                                                                     
D at e/ Ti m e 
( m m/ d d/ y y y y  G M T): 
Si g n e d  b y:
J u stifi c ati o n :
0 6/ 2 3/ 2 0 1 6 1 4: 1 9: 0 0
0 6/ 2 1/ 2 0 1 6 1 7: 0 5: 4 2
0 6/ 2 1/ 2 0 1 6 1 5: 2 3: 1 0
0 6/ 2 1/ 2 0 1 6 1 5: 1 9: 5 4
A l c o n - B usi n ess  Us e  O nl y  
 
Eff e cti v e  D at e:   
D o c u m e nt:   
V e rsi o n:   
St at us:   
Pri nt e d  B y:  
Pri nt  D at e:   
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 0 5 9 7
2 3-J u n- 2 0 1 6