Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population
Phase: NA
Conditions: Aphakia, Corneal Astigmatism
Sponsor: Alcon Research



Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
I n v esti gat or A gree me nt: 
 
•  
I h a ve rea d t he cli nical st u d y des cri be d h erei n, r ec o g nize its c o nfi de ntialit y, a n d 
a gree t o c o n d uct t he des cri be d trial i n c o m plia nce wit h G o o d Cli nical Practice 
( G C P), t he et hical pri nci ples c o ntai ne d wit hi n t he Declarati o n of Helsi n ki, t his 
pr ot oc ol, all a p plica ble re g ulat or y a ut h orit y re g ulati o ns, a n d c o n diti o ns of  a p pr o val 
i m p ose d b y t he re vie wi n g I R B or re g ulat or y a ut h orit y. 
•  
I will s u per vise all testi n g of t he d e vice i n v ol vi n g h u ma n s u bjects a n d e ns ure t hat 
t he re q uire m e nts relati n g t o o btai ni n g i nf or me d c o nse nt a n d I R B re view a n d 
a p pr o val  are met  i n acc or da nce  wit h  a p plica ble  l o cal a n d  g o ver n me nt al  re g ulati o ns. 
•  
I ha v e  rea d a n d  u n dersta n d  t he a p pr o priat e  use  of  t he i n vesti gati o nal pr o d uct(s)  as 
descri be d i n t he pr ot o c ol, pr o d uct i nf or mati o n, or ot her s o urces pr o vi de d b y t he 
S p o ns or.  
•  
I u n d ersta n d  t he p ote ntial  ris ks a n d si de effects  of  t he i n vesti gati o nal pr o d uct(s).  
•  
I a gree t o mai ntai n a de q u ate a n d acc urate rec or ds i n acc or da nce wit h g o v er n me nt 
re g ulati o ns a n d t o ma ke t h ose rec or ds a vaila bl e f or i ns pecti o n. 
•  
I a gree t o c o m pl y wit h all ot her re q uir e me nts re gar di n g t he o bli gati o ns of cli nical 
I n v esti gat ors a n d all ot her perti ne nt re q uir e me nts of t he S p o ns or a n d g o ver n me nt 
a ge ncies.  
•  
I a gree t o e ns ure t hat all ass ociates, c ollea g ues, a n d e m pl o yees assisti n g i n t he 
c o n d uct of t he st u d y are i nf or me d of t heir o bli gati o ns i n mee ti n g t he a b o v e 
c o m mit me nts. 
 
Pri nci pal I n v esti gat or:  
 
 
Na me a n d  pr ofessi o nal 
p ositi o n:  
A d dress:  
 
 
 
Si g nat ure  
Date  
Ha ve y o u e v er bee n dis q ualifie d as a n I n v esti gat or b y a n y Re g ulat or y A ut h orit y?  
 N o  
Yes  
Ha ve  y o u e v er bee n i n v ol ve d i n a st u d y or ot h er researc h t hat was ter mi nat e d?  
 N o  
Yes  
If yes, pleas e e x plai n here: 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
T a ble of C o nte nts  
Cli nical I n vesti gati o n of t he Vis ual O utc o mes a n d Safet y of Acr y S of ® I Q P a n O pti x® T oric  
Trif ocal I O Ls i n  Asia n  P o p ulati o n  ....................................................................................... 1  
Ta ble  of  C o nte nts  ....................................................................................................................... 3  
List  of  Ta bl es......................................................................................................................................... 6  
List  of  Fi g ures  ............................................................................................................................ 6  
1 
G L O S S A R Y  O F  T E R M S  .................................................................................................... 7  
2 
LI S T O F A C R O N Y M S  A N D  A B B R E VI A TI O N S  .............................................................. 1 1  
3 
P R O T O C O L  S U M M A R Y  ................................................................................................. 1 3  
4 
P R O T O C O L  A M E N D M E N T S  ......................................................................................... 2 1  
4. 1  
A me n d me nts  ...................................................................................................... 2 2  
5 
I N T R O D U C TI O N ............................................................................................................. 2 2  
5. 1  
Rati o nale  a n d Bac k gr o u n d  ................................................................................ 2 2  
5. 2  
P ur p ose of t he St u d y  .......................................................................................... 2 2  
5. 3  
Ris ks a n d Be nefits  ............................................................................................. 2 3  
5.3.1  
K n o w n a n d  P ote ntial  Ris ks  ................................................................ 2 3  
5.3.2  
P ote ntial  Be nefits  ............................................................................... 2 4  
6 
S T U D Y  O BJ E C TI V E S  ...................................................................................................... 2 4  
6. 1  
Pri mar y  Effecti ve ness  O bjecti ve(s)  ................................................................... 2 4  
 
 
6. 2  
Safet y  O bjecti ve(s)  ............................................................................................ 2 6  
 
 
7 
I N V E S TI G A TI O N A L P L A N  ............................................................................................. 2 7  
7. 1  
St u d y  Desi g n ...................................................................................................... 2 7  
7. 2  
Rati o nale f or  St u d y  Desi g n ................................................................................ 2 7  
 
 
 
7. 3  
Data  M o nit ori n g  C o m mittee  .............................................................................. 2 8  
8 
S T U D Y  P O P U L A TI O N  ............................................................................................................. 2 8  
8. 1  
I n cl usi o n Criteria ............................................................................................... 2 8  
8. 2  
E x cl usi o n Criteria  .............................................................................................. 2 9  
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
8. 4  
Rescree ni n g  of  S u bjects  .................................................................................... 3 1  
9 
T R E A T M E N T S  A D MI NI S T E R E D  ................................................................................... 3 1  
9. 1  
I n v esti gati o nal Pr o d uct(s) .................................................................................. 3 1  
9. 2  
Ot her Me dic al De vic e or Me dicati o n S pecifie d f or Use d uri n g t he St u d y  ....... 3 3  
9. 3  
Treat me nt  Assi g n me nt  ....................................................................................... 3 3  
9. 4  
Treat me nt  Mas ki n g  ............................................................................................ 3 4  
9. 5  
Acc o u nta bilit y  Pr oce d ures  ................................................................................. 3 4  
9. 6  
C ha n ges t o c o nc o mita nt me dicati o ns, treat me nts/ pr oce d ures  ........................... 3 4  
10  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  ............................................................. 3 5  
1 0. 1  I nf or me d C o nse nt a n d Scree ni n g  ...................................................................... 3 5  
1 0. 2  Visits  a n d E x a mi nati o ns  .................................................................................... 3 5  
10.2.1  
Visit 0: Pre o perati ve Scree ni n g  Visit  ..................................................... 3 5  
10.2.2  
Visit 0 0: S ur ger y Visit  1 st E ye ............................................................ 3 7  
10.2.3  
Visit 1: P ost o perati ve f or 1 st E ye ( 1 -2 Da ys aft er  Visit  0 0)  ............... 3 8  
10.2.4  
Visit 2: P ost o perati ve f or 1 st E ye ( 7 -1 4 Da ys aft er  Visit  0 0)  ............. 3 9  
10.2.5  
Visit 0 0 A: S ur ger y Visit 2 n d E ye (rec o m me n de d 7-1 4 Da ys after Visit  
0 0)  ...................................................................................................... 3 9  
10.2.6  
Visit 1 A: P ost o perati ve f or 2 n d E ye ( 1-2 Da ys after  Visit  0 0 A)  ......... 3 9  
10.2.7  
Visit 2 A: P ost o perati ve f or 2 n d E ye ( 7-1 4 Da ys after  Visit  0 0 A)  ....... 3 9  
10.2.8  
Visit 3 A: P ost o perati ve f or B ot h E yes ( 3 0 -6 0 Da ys after Visit 0 0 A)  4 0  
10.2.9  
Visit 4 A: P ost o perati ve f or B ot h E yes ( 9 0 -1 2 0 Da ys aft er Visit  0 0 A)  
...........................................................................................................4 0  
10.2.10  Visit 5 A: P ost o perati ve f or B ot h E yes ( 1 8 0 -2 1 0 Da ys after Visit  0 0 A)  
4 2  
10.2.11  U nsc he d ule d  Visit  ..................................................................................... 4 2  
1 0. 3  Disc o nti n ue d  S u bjects  ....................................................................................... 4 3  
10.3.1  
Scree n  Fail ures  .................................................................................. 4 3  
10.3.2  
Disc o nti n uati o ns  ................................................................................ 4 3  
10.3.3  
Sc he d ule of Pr oce d ures a n d Assess me nts f or S u bjects Disc o nti n ue d  
fr o m I n vesti gati o nal Pr o d uct ............................................................. 4 4  
10.3.4  
S u bject L ost t o  F oll o w  U p  ................................................................. 4 4  
1 0. 4  S u bject Pre g n a nt  or  Lact ati n g  ........................................................................... 4 4  
1 0. 5  Cli nical  St u d y  Ter mi nati o n  ................................................................................ 4 4  
10.5.1  
F oll o w -u p of s u bjects aft er st u d y p artici pati o n  has  e n de d  ................ 4 5  
1 0. 6  C o nti n ge nc y  M eas ures  ...................................................................................... 4 5  
11  A D V E R S E E V E N T S A N D  D E VI C E  D E FI CI E N CI E S  .................................................... 4 5  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 1. 1  Ge neral  I nf or mati o n .......................................................................................... 4 5  
1 1. 2  S p ecific E ve nts Rele v a nt t o t his  Pr ot oc ol  .......................................................... 4 6  
11.2.1  
De vice  D eficie ncies  ........................................................................... 4 7  
1 1. 3  M o nit ori n g f or  A d vers e  E ve nts  .......................................................................... 4 7  
1 1. 4  Pr oce d ures f or Rec or di n g  a n d Re p orti n g  ........................................................... 4 8  
1 1. 5  I nte nsit y a n d Ca us alit y  Assess me nts  ................................................................. 4 9  
11.5.1  
I nte nsit y ( Se verit y) ............................................................................ 4 9  
11.5.2  
Ca usalit y  ............................................................................................ 4 9  
1 1. 6  Ret ur n  Pr o d uct  A nal ysis  .................................................................................... 5 0  
1 1. 7  U n mas ki n g of t h e  St u d y  Treat me nt  ................................................................... 5 0  
1 1. 8  F oll o w -U p of S u bjects wit h  A d verse  E v e nts  ..................................................... 5 0  
1 1. 9  Pre g n a nc y i n t he  Cli nical  St u d y  ........................................................................ 5 0  
12  A N A L Y SI S  P L A N  ............................................................................................................. 5 1  
1 2. 1  S u bject E val ua bilit y ........................................................................................... 5 1  
1 2. 2  A nal ysis  Sets  ..................................................................................................... 5 1  
1 2. 3  De m o gra p hic a n d Baseli ne C haracteristics  ....................................................... 5 1  
1 2. 4  Effecti ve n ess  A nal ys es  ...................................................................................... 5 2  
12.4.1  
A nal ysis of Ke y  Effecti v e ness  E n d p oi nt(s)  ....................................... 5 2  
1 2. 4. 1. 1  
Statistical  H y p ot hes es  ........................................................ 5 2  
1 2. 4. 1. 2  
A nal ysis  Met h o ds  .............................................................. 5 2  
 
 
 
 
 
 
1 2. 5  Ha n dli n g of Missi n g Dat a  ................................................................................. 5 4  
1 2. 6  Safet y  A nal yses  ................................................................................................. 5 4  
12.6.1  
A nal ysis of Ke y  Safet y  E n d p oi nt(s)  .................................................. 5 4  
1 2. 6. 1. 1  
Statistical  H y p ot hes es  ........................................................ 5 4  
1 2. 6. 1. 2  
A nal ysis  Met h o ds  .............................................................. 5 4  
 
 
 
 
 
 
 
 
1 2. 8  Sa m ple Siz e J ustificati o n  ................................................................................... 5 6  
13  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 ................................ 5 7  
1 3. 1  S u bject C o nfi de ntialit y  ...................................................................................... 5 7  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 6  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 3. 2  C o m pleti o n of S o urce D oc u me nts a n d Case  Re p ort  F or ms  .............................. 5 7  
1 3. 3  Data Re vie w a n d Clar ificati o ns ......................................................................... 5 8  
1 3. 4  S p o ns or a n d M o nit ori n g Res p o nsi bilities  ......................................................... 5 9  
1 3. 5  Re g ulat or y D oc u me ntati o n a n d  Rec or ds Rete nti o n  .......................................... 5 9  
1 3. 6  Q ualit y Ass ura nce a n d  Q ualit y  C o ntr ol  ............................................................. 5 9  
14  E T HI C S  ........................................................................................................................... 6 0  
15  R E F E R E N C E S  ................................................................................................................ 6 1  
1 5. 1  Refere n ces a p plica ble f or all  cli nical  st u dies .................................................... 6 1  
1 5. 2  Refere n ces f or t his cli nical st u d y  ...................................................................... 6 1  
 
 
List of T a bles  
Ta ble  2 – 1  
List of Acr o n y ms a n d A b bre viati o ns Use d i n  T his  Pr ot oc ol ............................ 1 1  
 
Ta ble  3 – 1  
Sc he d ule of St u d y Pr oce d ures  a n d Assess me nts  .............................................. 1 9  
Ta ble  6 – 1  
Pri mar y  O bj ecti ve(s)  ........................................................................................ 2 5  
Ta ble  6 – 2  
Safet y  O bjecti ve(s)  ........................................................................................... 2 6  
Ta ble  9 – 1  
Test  Pr o d uct ...................................................................................................... 3 1  
List of Fi g ures  
Fi g ure 1 1. 1 – 1 Cate g orizati o n of All  A d verse  E v e nts  .............................................................. 4 6  
Fi g ure 1 1. 1 -2  C ate g orizati o n of All  Seri o us  A d verse  E v e nts  ................................................. 4 6  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 7  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1  G L O S S A R Y O F  T E R M S  
 
Na mes of test pr o d u ct(s)  
T hr o u g h o ut t his d oc u me nt, test pr o d uct(s) will be referre d t o 
as Pa n O pti x  T oric  Trif ocal  I O L ( M o dels: T F N T 3 0,  T F N T 4 0, 
T F N T 5 0,  T F N T 6 0)  
Na me of  C o ntr ol Pr o d uct(s)  N/ A  
Asia n P o p ulati o n  
Self -i de ntifie d as bei n g of C hi nese, J a pa nese, K orea n, or 
M o n g olia n des ce nt.  
A d verse D e vice Effect  
A d verse e ve nt rel ate d t o t he use of a n i n vesti gati o nal 
me dical de vice (test pr o d uct) or c o ntr ol pr o d uct. N ote: T his 
defi niti o n i ncl u des a dverse eve nts res ulti n g fr o m i ns ufficie nt 
or i n a de q u ate i nstr ucti o ns f or use, de pl oy me nt, 
i m pl a nt ati o n, i nst all ati o n, or o per ati o n; a ny m alf u ncti o n; 
a n d use err or or i nte nti o n al mis use of t he test pr o d uct or 
c o ntr ol pr o d uct.  
A d ve rse E v e nt 
A n y u nt o w ar d me dical occ urre nce, u ni nte n de d disease or 
i nj ur y, or u nt o w ar d cli nical si g ns (i ncl u di n g a b n or mal 
la b orat or y fi n di n gs) i n s u bjects, users or ot her pers o ns, 
w het her or n ot relate d t o t he i n vesti gati o nal me dical de vice 
(test pr o d uct). N ote: F or s u bjects, t his defi niti o n i ncl u des 
eve nts rel ate d t o t he test pr o d uct, t he c o ntr ol pr o d uct, or t he 
pr oce d ures i nv olve d. F or users or ot her pers o ns, t his 
defi niti o n is restricte d t o eve nts rel ate d t o t he test pr o d uct.  
 
Re q uire me nts f or re p orti n g A d verse E v e nts i n t he st u d y ca n 
be f o u n d i n Secti o n 1 1.  
A ntici pate d Seri o us 
A d verse D e vice Effect  
Seri o us a d verse d e vice effect w hic h b y its nat ur e, i nci de nce, 
se verit y, or o utc o me h as bee n i de ntifie d i n t he ris k 
ma na ge me nt file.  
De vice D eficie n c y  
I n a de q uac y of a me dical de vice wit h res p ect t o its i de ntit y, 
q ualit y, d ura bilit y, relia bilit y, s afet y, or perf or ma n ce. N ote: 
T his defi niti o n i ncl u des m alf u ncti o ns, use err ors, a n d 
i n a de q u ate l a beli n g. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 8  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
Re q uire me nts f or re p orti n g De vice Defi cie ncies i n t he st u d y 
ca n be f o u n d i n Secti o n 1 1.  
E nr olle d S u bject  
A n y s u bject w h o si g ns a n i nf or me d c o nse nt f or m f or 
partici pati o n i n t he st u d y.  
I nter ve nti o nal Cli nical Trial A researc h tri al t hat pr os pecti vel y assi g ns, w het her 
ra n d o ml y or n ot, h u ma n partici pa nts or gr o u ps of h u ma ns t o 
o ne or m ore h ealt h -relate d i nter ve nti o ns t o e val uat e t he 
effects o n healt h o utc o m es, a n d/ or a researc h tri al i n w hic h 
dia g n ostic or m o nit ori n g pr oce d ures be y o n d sta n d ar d of  care 
are c o n d u cte d a n d ge nerate o utc o mes f or us e i n a n al ysis of 
data.  
Malf u ncti o n  
Fail ure of a me dical de vi ce t o perf or m i n acc or da nce wit h its 
i nte n de d p ur p ose w he n use d i n acc or da nce wit h t he 
i nstr ucti o ns f or use or cli nical i n vesti gati o n pla n. 
N o n -seri o us A d verse E v e nt 
A d verse e ve nt t hat d oes n ot meet t he criteria f or a seri o us 
a d verse e ve nt.  
P ost mar keti n g/ P ost - 
a ut h orizati o n st u d y 
A n y st u d y c o n d u cte d wit hi n t he c o n diti o ns lai d d o w n i n 
pr o d uct la belli n g a n d ot h er c o n diti o ns lai d d o w n f or t he 
mar keti n g of t he pr o d u ct or u n der n or m al c o n diti o ns of use. 
A p ost mar keti n g st u d y falls eit her wit hi n t he defi niti o ns of 
a n i nter ve nti o nal or a n o n - i nter ve nti o nal st u d y a n d ma y als o 
fall wit hi n t he defi niti o n of a p ost-a p pr o val st u d y.  
Pr o d uct C o m plai nts  
A n y oral, electr o nic, or writte n c o m m u nicati o n t hat alle ges 
deficie nci es relat e d t o t he i de ntit y (la b eli n g), q ualit y, 
d ura bilit y, relia bilit y, safet y, effecti ve ness, or p erf or ma nce 
of a mar k ete d pr o d uct, i n cl u di n g fail ure of t he pr o d uct, 
la beli n g or pac k a gi n g t o meet s pecificati o ns, w het her or n ot 
t he pr o d uct is relate d t o or ca use d t h e alle ge d d eficie nc y. A 
c o m plai nt ma y alle ge t hat a n a d verse e ve nt or m e dical 
de vice malf u n cti o n has o cc urre d.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 9  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
Seri o us A d verse D e vice 
Effect ( S A D E)  
A d verse d e vice effect t hat has res ulte d i n a n y of t h e 
c o nse q ue n ces c h aracteristic of a seri o us a d v erse e ve nt.  
Seri o us A d verse E v e nt 
( S A E) 
A d verse e ve nt t hat le d t o a n y of t he f oll o wi n g:  
 
•  
Deat h.  
•  
A seri o us deteri orati o n i n t he healt h of t he  s u bject 
t hat eit her res ulte d i n: 
a. a life-t hreate ni n g ill ness or i nj ur y. 
N ote: Life -t hre ate ni n g me a ns t h at t he i n divi d u al 
w as at i m me di ate risk of de at h fr o m t he eve nt as it 
occ urre d, ie, it d oes n ot i ncl u de a n eve nt w hic h 
hy p ot hetic ally mi g ht h ave c a use d de at h h a d it 
occ urre d i n a m ore s ever e f or m.  
b. a n y p ot e ntiall y si g ht -t hreate ni n g e ve nt or 
per ma ne nt i m pair me nt t o a b o d y str u ct ure or  a 
b o d y  f u ncti o n. 
c. i n-patie nt h os pitalizati o n or  pr ol o n ge d 
h os pitalizati o n.  
N ote: Pl a n ne d h os pit aliz ati o n f or a pre -existi n g 
c o n diti o n, wit h o ut seri o us deteri or ati o n i n he alt h, 
is n ot c o nsi dere d a seri o us a dverse eve nt. I n 
ge ner al, h os pit aliz ati o n si g nifies t h at t he 
i n divi d u al re m ai ne d at t he h os pit al or e mer ge ncy 
w ar d f or o bserv ati o n a n d/ or tre at me nt ( us u ally 
i nv olvi n g a n over ni g ht st ay) t h at w o ul d n ot h ave 
bee n a p pr o pri ate i n t he p hysici a n's office or a n 
o ut -p atie nt setti n g. C o m plic ati o ns t h at occ ur 
d uri n g h os pit aliz ati o n are a dverse eve nts. If a 
c o m plic ati o n pr ol o n gs h os pit aliz ati o n or f ulfills 
a ny ot her seri o us criteri a, t he eve nt is seri o us.  
W h e n i n d o u bt as t o w het her “ h os pit aliz ati o n ” 
occ urre d, t he ev e nt s h o ul d be c o nsi dere d s eri o us.  
d. a me dical or s ur gi cal i nter ve nti o n t o pre ve nt a)  or 
b), or a n y oc ul ar sec o n dar y s ur gical i nter v e nti o n 
e x cl u di n g p osteri or  ca ps ul ot o m y.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 0  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
e. a n y i n direct h ar m as a c o nse q ue nce of i nc orrect 
dia g n ostic test res ults w he n use d wit hi n 
ma n ufact ur er’s i nstr ucti o ns f or use.  
•  
Fetal distress, f etal deat h, or a c o n ge nital a b n or malit y 
or birt h  defect.  
Refer t o Secti o n 1 1 f or a d diti o n al S A Es.  
Seri o us P u blic Healt h 
T hreat  
A n y e ve nt t y pe w hic h res ults i n i m mi ne nt ris k of deat h, 
seri o us deteri or ati o n i n state of healt h, or seri o us ill ness t hat 
re q uires pr o m pt r e me dial acti o n. T his w o ul d i ncl u de: E ve nts 
t hat are of si g nifica nt a n d u ne x pecte d nat ure s u c h t hat t he y 
bec o me al ar mi n g as a p ot e ntial p u blic healt h hazar d, e g, 
h u ma n  i m m u n o deficie nc y vir us ( HI V) or Bir d Fl u. 
U na ntici pate d Seri o us 
A d verse De vic e  Effect 
( U S A D E) 
Seri o us a d verse d e vice effect w hic h b y its nat ur e, i nci de nce, 
se verit y or o utc o me h as n ot bee n i de ntifie d i n t he ris k 
ma na ge me nt file.  
Use Err or  
Act or o missi o n of a n act t hat res ults i n a differe nt me dical 
de vice res p o nse t ha n i nte n de d b y m a n ufact urer or e x pecte d 
b y user. N ote: T his defi niti o n i ncl u des sli ps, l a pses, a n d 
mist akes. A n u nex p ecte d p hysi ol o gic al res p o nse of t he 
s u bject d oes n ot i n itself c o nstit ute a use err or.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 1  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
2  LI S T  O F  A C R O N Y M S  A N D  A B B R E VI A TI O N S  
 
T a ble  2 – 1  
List  of  Acr o n y ms  a n d  A b bre vi ati o ns  Use d  i n T his  Pr ot oc ol  
 
A b bre vi ati o n  
Defi niti o n  
A C D  
A nteri or c h a m ber de pt h  
A A S  
All -i m pla nte d a nal ysis set 
A D E  
A d verse d e vice effect  
A E  
A d verse e ve nt  
A L  
A xial le n gt h  
 
 
B C D V A  
Best c orrecte d dista nce vis ual ac uit y  
c m 
Ce nti meter  
C R F  
Case re p ort f or m  
CI  
C o nfi de nce I nter val  
D  
Di o pter  
D CI V A  
Dista nce c orrecte d i nter me diate vis ual ac uit y  
D C N V A  
Dista nce c orrecte d near vis ual ac uit y  
D F U  
Directi o ns f or us e  
D E P  
De viati o ns a n d E val ua bilit y Pla n  
 
 
e C R F 
Electr o nic case re p ort f or m  
E D C  
Electr o nic data ca pt ur e  
eI F U  
Electr o nic i nstr ucti o ns f or use  
E U  
E ur o pea n U ni o n  
G C P  
G o o d Cli nical Practice  
I C F 
I nf or me d c o ns e nt f or m 
I C H 
I nter nati o nal C o nfere nce o n Har m o nizati o n 
I E C 
I n d e pe n de nt et hics c o m mittee 
I F U 
I nstr u cti o ns f or use 
I O L 
I ntr a oc ular le ns 
 
 
 
 
I P 
I n v esti gati o nal pr o d uct 
I R B 
I nstit uti o nal Re vie w B oar d 
I S O 
I nter nati o nal Or ga nizati o n f or Sta n dar dizati o n 
L A SI K  
laser-assiste d i n sit u kerat o mile usis  
l o g M A R 
L o garit h m of mi ni m u m a n gle of res ol uti o n  
L RI  
Li m bal r ela xi n g i ncisi o n  
m  
Meter  
Me d D R A
®  
Me dical Dicti o nar y f or R e g ul at or y Acti vities  
m m  
Milli meter  
M O P  
Ma n ual of pr o ce d ures  
N/ A  
N ot a p plica ble  
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 2  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
O D  
Ri g ht e ye  
O S  
Left e ye  
O V D  
O p ht hal mic visc os ur gi cal de vices  
PI  
Pri nci pal I n v esti gat or  
Q U VI D  
Q uesti o n naire f or Vis ual Dist ur ba nces  
S A D E  
Seri o us a d verse d e vice effect  
S A E  
Seri o us a d verse e ve nt  
S S  
Safet y a nal ysis set  
S D  
Sta n dar d de viati o n  
S O P  
Sta n dar d o perati n g pr oce d ures  
S P H  
S p here  
S SI  
Sec o n dar y s ur gi cal i nter v e nti o n  
T R R E  
Tar get r esi d ual refracti ve err or 
 
 
 
 
 
 
V A  
Vis ual ac uit y  
Y A G  
Yttri u m -Al u mi n u m Gar net  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 3  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
3  P R O T O C O L  S U M M A R Y  
 
I n vesti g ati o n al 
pr o d uct t y pe  
De vice  
St u d y t y pe  
I nter ve nti o nal 
I n vesti g ati o n al 
pr o d ucts  
A C R Y S O F ® I Q Pa n O pti x® T oric Trif ocal I ntr a oc ular Le nses  
(I O Ls) ( M o d els: T F N T 3 0, T F N T 4 0, T F N T 5 0, T F N T 6 0) 
P ur p ose a n d 
r ati o n ale 
T he prese nt st u d y is i nte n de d t o c o nfir m t he effecti ve ness a n d 
safet y of t he Pa n O pti x T oric Trif ocal i n Asia n p o p ulati o n, 
es peciall y f or vis u al perf or ma nce. 
 
 
O bjecti ve(s)  
T o e val uate t he cli nical p erf or ma n ce of t he A C R Y S O F ® I Q 
Pa n O pti x ® T oric Trif ocal i ntra oc ular le ns es ( M o del T F N T 3 0, 
T F N T 4 0, T F N T 5 0, T F N T 6 0) w he n i m pla nte d t o r e place t h e 
nat ural le ns f oll o wi n g cat aract re m o val i n Asia n P o p ulati o n.  
Pri mar y Effecti ve ness o bjecti ves are t o descri be t he f oll o wi n g at 
M o nt h 3 a n d M o nt h 6 f or all o perati ve e yes:  
•  Resi d ual ma nifest  c yli n d er  
•  I O L r otati o nal sta bilit y 
•  Bi n oc ular Best C orrecte d Dista nce Vis ual A c uit y 
( B C D V A) ( 4 m fr o m s pectacle pla n e) i n p h ot o pic li g hti n g 
•  Bi n oc ular Dista nce C orrecte d I nter m e diate Vis ual Ac uit y 
( D CI V A) ( 6 0 c m fr o m s p ectacl e pla ne) i n p h ot o pi c li g hti n g 
•  Bi n oc ular Dista nce C orrecte d Near Vis ual A c uit y 
( D C N V A) ( 4 0 c m fr o m s pectacl e pla ne) i n p h ot o pic 
li g hti n g 
Safet y o bj ecti ves are t o d escri be t he f oll o wi n g at M o nt h 3 a n d 
M o nt h 6 f or all o perati ve e yes:  
•  Esti mate t he c u m ulati ve rate of sec o n dar y  s ur gical 
i nter ve nti o ns ( S SIs) 
•  E val uate t he rates of se v ere a n d m ost b ot hers o me vis ual 
dist ur ba nces usi n g t he Q U VI D q uesti o n nair e  
•  E val uate t he rates of a d v erse e v e nts  
E n d p oi nt(s)  
Pri mar y Effecti ve ness E n d p oi nts at M o nt h 3 a n d 6:  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 4  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
•  Mea n m o n oc ular resi d ual ma nifest c yli n der f or all 
o perati ve e yes f or all I O L m o dels  c o m bi ne d  
•  Perce nt of I O Ls wit h < 1 0 de gree r otati o n f or all  o perati ve 
e yes (r otati o n defi ne d as t he differe nce i n I O L a xis of 
orie ntati o n fr o m p ost o p da y  1)  
•  Mea n bi n oc ular B C D V A at 4 m i n p h ot o pic  li g hti n g 
c o n diti o n  
•  Mea n bi n oc ular D CI V A at 6 0c m i n p h ot o pic  li g hti n g 
c o n diti o n  
•  Mea n bi n oc ular D C N V A at 4 0 c m i n p h ot o pic li g hti n g 
c o n diti o n  
Safet y E n d p oi nts:  
•  Rate of S SIs (i n cl u di n g rate of S SIs relate d t o o pti cal 
pr o perties of t he I O L a n d rate of all  S SIs)  
•  Rates of se vere a n d m ost b ot hers o me (se p aratel y) vis ual 
dist ur ba nces re p orte d b y Q U VI D q uesti o n naire f or  s u bjects 
wit h bi n oc ular i m pla ntati o n b y  visit  
•  Rates of a d verse  e ve nts  
 
 
Assess me nt(s)  
Effecti ve ness:  
•  Dista nce Vis ual Ac uit y at 4  m  
o  
 Bi n oc ular B C D V A i n p h ot o pic 
 
li g hti n g c o n diti o n  
 
 
 
•  I nter me diate Vis ual Ac uit y at 6 0  c m 
o  
 Bi n oc ular D CI V A i n p h ot o pic 
li g hti n g c o n diti o n 
o  
 
 
•  Near Vis ual Ac uit y at 4 0  c m 
o  
 Bi n oc ular D C N V A i n p h ot o pic
 
li g hti n g c o n diti o n  
o  
 
 
 
 
•  Ma nifest refracti o n  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 5  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
•  I O L r otati o n (c o m p are d t o act ual a xis p ositi o n da y 1 
p ost o perati ve)  
•  
 
 
S afet y:  
•  Sec o n dar y S ur gical I nter ve nti o ns  ( S SIs) 
•  Q U VI D S u bject S ur ve y ( bi n oc ular) t o assess vis ual 
dist ur ba nces  
•  A d verse  E ve nts  
 
 
•  Dilate d F u n d us E x a mi nati o n  
 
 
•  Slit -la m p Bi o micr osc o p y E x a mi nati o n 
 
 
 
 
 
 
 
 
 
 
 
A d diti o n al:  
•  Oc ular Bi o metr y ( A xial Le n gt h, Kerat o metr y, a n d  A nteri or 
C ha m ber De pt h wit h c or neal t hic k ness, le ns t hic k ness, a n d 
w hite t o w hite b ot h pre a n d  p ost -o perati ve)  
St u d y Desi g n  
Pr os pecti ve, u n mas ke d, si n gle ar m, m ulti -ce nter, p ost mar ket 
st u d y; t otal d urati o n of a s u bject’s partici pati o n is a p pr o xi matel y 
8 m o nt hs.  
S u bject p o p ul ati o n  
A d ult Asia n s u bjects, 2 0 years of a ge or ol d er, w h o self -i de ntif y as 
bei n g of C hi nes e, J a pa nese, K orea n, or M o n g olia n desce nt, w h o 
re q uire bilateral cataract e xtracti o n b y p hac oe m ulsificati o n a n d 
ha ve pre -e xisti n g c or neal asti g matis m, desire a n I O L t hat pr o vi des 
t he p ote ntial c orrecti o n f or near, i nter me diate a n d dista nce visi o n 
as well as f or pre-e xisti n g c or neal asti g matis m.  
Pla n ne d n u m ber of s u bjects e nr olle d/c o nse nte d: 6 3 s u bjects 
Pla n ne d n u m ber of i m pla nte d s u bjects: 5 6 s u bjects  
Pla n ne d n u m ber of c o m plete d s u bjects: 5 0 s u bjects  
Ke y i ncl usi o n 
criteri a  
•  Pla n ne d bilateral cataract re m o val f oll o we d b y p osteri or 
c ha m ber I O L i m pla ntati o n wit h P a n O pti x T oric  ( T F N T 3 0, 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 6  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
( See Secti o n <8. 1 > 
f or a c o m plet e list of 
i ncl usi o n criteria) 
T F N T 4 0, T F N T 5 0, or T F N T 6 0)  
•  Calc ulate d tar get resi d ual refracti ve err or wit hi n ± 0. 5 0 D  of 
e m metr o pia wit hi n t he c o m merciall y a vaila ble I O L P o wer 
Ra n ge i n b ot h o perati ve  e yes  
•  Pre o perati ve re g ular c or neal kerat o metric asti g matis m 
wit h pre dicte d resi d ual refracti ve asti g matis m ≤ 0. 5 0 D i n 
b ot h o perati ve  e yes  
Ke y e xcl usi o n 
criteri a  
( See Secti o n <8. 2 > 
f or a c o m plet e list of 
e x cl usi o n criteria)  
•  Pre o perati ve irre g ular  asti g matis m  
•  Cli nicall y si g nifica nt c or neal a b n or malities, e g, c or neal 
d ystr o p h y, i nfla m mati o n, e de ma, et. al., or c or neal  irre g ularit y 
•  Gla uc o ma  
•  Hist or y of or c urre nt r eti nal  disease  
•  Hist or y of c urre nt a nteri or or p osteri or se g m e nt  i nfla m mati o n 
•  A n y  ot her  pla n ne d  o c ular  s ur gical pr oce d ures  i ncl u di n g b ut  n ot 
li mite d t o li m bal rela xi n g i ncisi o n ( L RI)/ Asti g mati c 
Kerat ot o m y a n d las er -assiste d i n sit u kerat o mile usis  ( L A SI K). 
D at a a n al ysis a n d 
s a m ple siz e 
j ustific ati o n 
D at a A n al ysis:  
Dataset Defi niti o ns:  
T he Safet y A nal ysis Set ( S S) will i ncl u de all e yes wit h atte m pte d 
I O L i m pla ntati o n (s uccessf ul or a b orte d after c o nt act wit h t he 
e ye). T h e S S will be t he pri mar y set f or all safet y a nal ys es.  
 
All -I m pla nt e d A nal ysis Set ( A A S) i ncl u des all e yes wit h 
s uccessf ul I O L i m pla ntati o n wit h at least o ne p ost-o perati ve visit 
a n d will be t he pri mar y a nal ysis set f or all effecti v e ness a nal yses 
. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 7  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
 
A nal ys es:  
T here are n o statistical h y p ot heses f or t he s afet y a n d effecti ve ness 
o bjecti ves i n t his st u d y.  
 
Pla n ne d a nal yses i ncl u de a descri pti ve s u m mar y of all 
effecti ve ness a n d s afet y e n d p oi nts u p t o M o nt h 6.  
 
 
 
 
 
 
 
 
 
 
  
 
 
. I O L r otati o n 
will be s u m marize d b y sa m ple siz e, n u m ber, perce nt, a n d 
c u m ulati ve perce nt f or t h e f oll o wi n g cate g ories of a bs ol ute 
r otati o n: ( < 1 0 a n d < 2 0 de grees) f or all m o dels c o m bi ne d. 
 
Descri pti ve statistics ge n erate d f or all e n d p oi nts wi ll be base d 
u p o n t he data t y pe (ie, w het her t he dat a are cat e g orical or 
c o nti n u o us) bei n g a nal yz e d. F or cate g orical e n d p oi nts, sa m ple 
siz e, n u m ber i n t he cate g or y, a n d perce nt i n t he cate g or y will be 
prese nte d. F or c o nti n u o us e n d p oi nts, sa m ple size, mea n, me dia n, 
sta n dar d de viati o n, mi ni m u m, ma xi m u m, a n d t w o-si de d 9 5 % 
c o nfi de nce i nter vals will be prese nt e d.  
 
Vis ual ac uit y will be s u m marize d as a c o nti n u o us meas ure. 
 
 
 
 
 
 
 
S a m ple Size J ustific ati o n:  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 1 8  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
 
T he c h oice of sa m ple siz e is n ot base d o n statistical c o nsi derati o ns. 
 
A p pr o xi matel y 5 6 s u bjects will be bilaterall y i m pla nte d t o o btai n 
data f or at least 5 0 s u bjects ( 1 0 0 e yes) at M o nt h 6, ass u mi n g a 
dr o p o ut  rate of  1 0 %  o ver  a 6 -m o nt h  peri o d.  T he  precisi o n  esti mates 
bel o w are pres e nte d f or i n di vi d ual e ye s u m maries. 
All e ye 
s u m maries will ha ve i ncrease d precisi o n.  
 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
 
Ke y w or ds  
Pr os pecti ve, m ulti -ce nter, si n gle ar m, p ost mar ket st u d y.  
Ass oci ate d m ateri als  S ur gical dis p osa bles us e d i n c o nj u ncti o n wit h t he I P (e g, O V Ds, 
cartri d ges) as per t he D F U a n d sta n dar d of care.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2 2  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
4. 1  A me n d me nts  
T here are n o a me n d me nts. T his is t he first versi o n of t he pr ot oc ol.  
 
5  I N T R O D U C TI O N 
5. 1  R ati o n ale a n d  B ac k gr o u n d  
M o n of ocal I O Ls are d esi g ne d t o r e place t he f o c usi n g p o wer of t he nat ural l e ns (t y pi call y 
after cataract s ur ger y) b y pr o vi di n g g o o d vis ual f u ncti o n t hr o u g h a si n gle, fi x e d, f ocal le n gt h, 
t h us ge nerall y c orrecti n g a s u bject’s dista nce visi o n. H o we ver, ma n y pse u d o p ha kic s u bjects 
i m pla nte d wit h m o n of ocal I O Ls ulti matel y re q uir e rea di n g glass es t o c o m pe nsate f or t h e l oss 
of t he a bilit y t o se e clearl y at i nter m e diate or near dista nces. Se veral I O L d esi g ns f or 
c o m pe nsati n g t h e acc o m m o dati o n i n pse u d o p ha kic s u bjects e xist i n m o der n da y cli nical 
practice, i n cl u di n g m ultif ocal I O Ls. M ultif ocal I O Ls offer s u bjects a n o p p ort u nit y t o  
o verc o me t he l oss of near a n d i nter me diate visi o n b y pr o vi di n g m ulti ple f o cal p oi nts. T he 
maj orit y of c o m merciall y a vaila ble m ultif ocal I O Ls pr o vi de t w o o ptical z o nes f or dista nce 
a n d near visi o n.  
 
T oric i ntra oc ular le nses c orrect a p ha kia as well as a n y p re-e xisti n g or s ur gicall y i n d u ce d 
c or neal asti g matis m ( H or n, 2 0 0 7; Ba uer, 2 0 0 8). T his pr o vi des a be nefit t o patie nts d ue t o 
free d o m fr o m s pecta cles f or dista nce visi o n w hic h is a n i m p orta nt c o nsi derati o n w he n 
c h o osi n g a n i ntra oc ular le ns ( La ne, 2 0 0 6; La ure n dea u et al, 2 0 0 9). A p pr o xi matel y t w o -t hir ds 
of patie nts w h o u n der g o cataract s ur ger y ha v e c or neal asti g m atis m bet wee n 0. 2 5 a n d 1. 2 5 D 
w hic h ca n si g nifica ntl y li mit t he desire d 2 0/ 2 0 vis ual ac uit y if t he asti g matis m is u nc orrecte d 
( Rile y et al., 2 0 0 1; Ferrer -Blasc o, 2 0 0 9).  
 
T he A C R Y S O F I Q Pa n O pti x T oric Trif ocal I ntra o c ular le ns t o be i m pla nte d i n t his st u d y is 
a p pr o ve d i n t he E U a n d A ustralia, al o n g wit h ot her c o u ntries. It pr o vi des dista nce visi o n, 
i nter me diate visi o n at a p pr o xi matel y 6 0 c m, a n d near visi o n at a p pr o xi matel y 4 0 c m, a n d 
c orrects f or c or neal asti g matis m. It is i n dicate d f or pri mar y i m pla ntati o n i n t he ca ps ular ba g 
i n t he p osteri or c ha m ber of t he e ye f or t he vis ual c orrecti o n of a p ha kia a n d pre-e xisti n g 
c or neal asti g matis m, i n a d ult patie n ts wit h or wit h o ut pres b y o pi a w h o desir e near, 
i nter me diate a n d dista nce visi o n wit h i ncrease d s p ectacl e i n de pe n de n ce. 
 
5. 2  P ur p ose of t he  St u d y  
T he prese nt st u d y is i nte n de d t o e val uate t h e cli nical perf or ma nce of t he P a n O pti x T oric 
Trif ocal i n a n Asi a n p o p ul ati o n, a n d t o de m o nstrate t hat t he a d diti o n of t he t oric c o m p o ne nt 
t o t he Pa n O pti x trif ocal desi g n re d uces pre-e xisti n g asti g matis m w hile pr o vi di n g f u ncti o nal  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2 3  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
visi o n at all dista nces (fr o m 4 0 c m t o i nfi nit y) wit h si g nifica ntl y fe wer pati e nts re p orti n g a n y 
nee d f or e ye glass es. T hes e res ulti n g d ata will be use d i n s u p p ort of o ne or m ore re gi o nal 
Healt h A ut h orit y s u b missi o ns.  
 
5. 3  Ris ks a n d Be nefits  
5. 3. 1  
K n o w n a n d P ote nti al  Ris ks  
C o m plicati o ns ma y occ ur o n t he s ur ger y d a y or t hr o u g h o ut t he p ost o perati ve peri o d. As wit h 
a n y t y p e of i ntra o c ular s ur ger y, t here is a p ossi bilit y of c o m plicati o ns d ue t o a nest hesia, dr u g 
reacti o ns, a n d s ur gical pr o ble ms. T he s ur gical pr o ce d ure ca n e x acer bate a pre-e xisti n g oc ular 
c o n diti o n. P ossi ble pr o ble ms d uri n g s ur ger y i ncl u de: c or neal e n d ot helial t o uc h, detac h e d 
Desce met’s me m bra n e, iris da ma ge, iris pr ola ps e, iris tra u ma, iris i ncarcerati o n, z o n ular 
r u pt ure, vitre o us l oss, ca ps ul or he xis tear, ca ps ular r u pt ure, u nc o ntr olla ble I O P, h y p he ma a n d 
reti nal da ma ge. A n I O P i ncreas e ma y occ ur fr o m t he s ur gical pr o ce d ure, resi d ual visc oelastic 
i n t he e ye or a st er oi d res p o nse t o p ost o perati ve m e dicati o ns. 
 
A d diti o nall y, p ote ntial p ost o perati ve a d v erse e ve nts i ncl u de b ut are n ot li mite d t o: c or neal 
str o mal e de ma, c yst oi d mac ular e d e ma, e n d o p ht hal mitis, h y p o p y o n, iritis, le ns disl ocati o n, 
me m bra ne f or mati o n o n t he I O L, p u pillar y bl oc k, reti nal detac h m e nt, c yclitic me m bra ne, 
tra nsie nt or persiste nt gla uc o ma, reti nal tear, vitritis, iris t o uc h, p u pil o valizati o n, p osteri or 
s y nec hiae, o c ular i nfla m mati o n, oc ular disc o mf ort or pai n, i nfla m mati o n, decrease d visi o n, 
decrease d c o ntrast se nsiti vit y, decreas e d c ol or p erce pti o n, vis ual dist ur ba nces a n d c or neal 
e n d ot helial cell l oss.  
 
A n I O L re place m e nt or e x pla ntati o n ma y b e a p pr o priate i n s o me cas e s of si g nifica nt resi d ual 
refracti ve err or, oc ular i nfecti o n, s u bject dissatisfacti o n, or vis ual dist ur ba nces (e g, gl are, 
hal os, star b ursts, haz y visi o n, bl urre d visi o n, d o u ble visi o n, vis ual dist orti o ns, a n d c ol or 
dist orti o ns). I n m ost of cases, s pecta cle s or c o ntact le nses ma y b e pres cri be d t o res ol ve 
resi d ual refracti ve err or. Ot her sec o n d ar y s ur gi cal i nter ve nti o ns i ncl u de b ut are n ot li mite d t o: 
I O L re p ositi o ni n g, refracti ve laser treat me nt, parace ntesis, vitre o us as pir ati o ns, iri dect o m y or 
laser iri d oto m y f or p u pillar y bl oc k, w o u n d lea k re pair, a n d reti nal detac h m e nt re pair.  
 
T here ma y als o be u n k n o w n ris ks wit h t he use of t he A C R Y S O F I Q Pa n O pti x T oric Trif ocal 
I O L. A n y f oresee n ris k t o s u bjects i n t his cli nical st u d y will be mi ni mize d b y c o m plia nce 
wit h t he eli gi bilit y criteri a, st u d y pr oce d ures, a n d cli nical m o nit ori n g.  
 
Refer t o t he Directi o ns f or Use ( D F U) f or a d diti o nal i nf or mati o n o n t he I O Ls bei n g us e d i n 
t his st u d y. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2 4  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
5. 3. 2  
P ote nti al  Be nefits  
T he A C R Y S O F I Q Pa n O pti x T oric Trif ocal I ntra o c ul ar le ns is a si n gle -piece, trif ocal 
diffracti ve l e ns wit h a near a d d p o w er of + 3. 2 5 D a n d a n i nter me diat e a d d p o wer of + 2. 1 7 D 
at t he I O L pla n e, a n d als o i ncl u des a t oric c o m p o ne nt. T his I O L is i nte n de d t o pr o vi de visi o n 
t o a p ha kic s u bjects at n ear, i nter me diate, a n d dista nce a n d t o c orrect pre -e xisti n g c or neal 
asti g matis m. ( T he p ote ntial be nefits of t he Pa n O pti x T oric Trif ocal I O L i ncl u de:  
 
•  
P ote ntial p ost o perati ve mea n 2 0/ 2 5 S nelle n (a b o ut 0. 1 l o g M A R) or b etter  u n c orrecte d 
vis ual ac uit y at all dista nces (fr o m 4 0 c m t o i nfi nit y) a n d  
•  
C orrecti o n of pree xisti n g c or neal asti g matis m  a n d  
•  
I m pr o v e d near a n d i nter me diate visi o n i n c o m paris o n t o a m o n of ocal I O L 
Base d o n t h e a b o ve, t h e ris k of u na ntici pate d a d v erse de vice effects wit h us e of t his I O L is 
c o nsi dere d t o  be l o w, a n d t he be nefits of recei vi n g t he I O L s h o ul d o ut wei g h t he ris ks f or 
s u bjects t hat q ualif y f or i m pla ntati o n i n t his st u d y. 
 
6  S T U D Y  O B J E C TI V E S  
T he o bjecti ve of t his st u d y is t o e val uat e t he cli nical perf or m a nce of t he A C R Y S O F I Q 
Pa n O pti x T oric Trif ocal i ntra oc ular l e nses ( M o dels: T F N T 3 0, T F N T 4 0, T F N T 5 0, T F N T 6 0) 
w he n i m pla nte d t o re pla ce t he nat ural le ns f oll o wi n g cataract r e m o val i n a n Asia n p o p ulati o n.  
 
6. 1  Pri m ar y Effecti ve ness  O bjecti ve(s)  
T he f oll o wi n g are t h e Pri mar y Effecti ve ness o bjecti ves a n d e n d p oi nts at M o nt h 3 a n d 
M o nt h 6 f or all o perati ve e yes:  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2 5  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
T a ble  6 – 1  
Pri m ar y  O bjecti ve(s)  
O bjecti ve(s)  
E n d p oi nt(s)  
 
Resi d ual  Ma nifest  C yli n der  
Mea n m o n oc ular resi d ual  ma nifest  c yli n der 
f or all o perati ve e yes f or all I O L m o dels 
c o m bi ne d  
I O L R otati o nal Sta bilit y  
Perce nt of I O Ls wit h < 1 0  de gree  r otati o n 
f or all o perati ve e yes (r ot ati o n defi ne d as 
t he differe nce i n I O L a xis of orie ntati o n 
fr o m p ost o p da y 1)  
Bi n oc ular Best C orrecte d Dista nce  Vis ual 
Ac uit y ( B C D V A) ( 4 m fr o m s pectacle 
pla ne) i n p h ot o pic li g hti n g  
Mea n bi n oc ular B C D V A at 4 m i n p h ot o pic 
li g hti n g c o n diti o n 
 
Bi n oc ular Dista nce C orrecte d I nter m e diate 
Vis ual Ac uit y ( D CI V A) ( 6 0 c m fr o m 
s pectacle pl a ne) i n p h ot o pic li g hti n g 
Mea n bi n oc ular D CI V A at 6 0c m i n p h ot o pic 
li g hti n g c o n diti o n 
 
Bi n oc ular Dista nce C orrecte d Near  Vis ual 
Ac uit y ( D C N V A) ( 4 0 c m fr o m s pectacle 
pla ne) i n p h ot o pic  li g hti n g 
Mea n bi n oc ular D C N V A at 4 0 c m i n 
p h ot o pic li g hti n g c o n diti o n  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2 6  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
 
 
 
 
 
 
 
 
 
6. 2  S afet y  O bjecti ve(s)  
T he f oll o wi n g are t h e Safet y o bje cti ves a n d e n d p oi nts at M o nt h 3 a n d M o nt h 6 f or all 
o perati ve e yes:  
 
T a ble  6 – 2  
S afet y  O bjecti ve(s)  
O bjecti ve(s)  
E n d p oi nt(s)  
Esti mate t he c u m ulati ve rate of sec o n dar y 
s ur gic al i nter ve nti o ns ( S SIs) 
 
E val uate t he rates of se v ere a n d m ost 
b ot hers o me vis ual dist ur ba nces usi n g t he 
Q U VI D q u esti o n naire  
Rate of S SIs (i ncl u di n g rate of S SIs  relate d 
t o o ptical pr o perties of t he I O L a n d rat e of 
all S SIs)  
Rates of se vere a n d m ost b ot hers o me 
(se paratel y) vis ual dist ur ba nces re p orte d b y 
Q U VI D q uesti o n naire f or s u bjects wit h 
bi n oc ular i m pla ntati o n b y visit  
E val uate t he rates of a d v erse e v e nts  
Rates of a d verse  e v e nts  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2 7  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
7  I N V E S TI G A TI O N A L P L A N  
7. 1  St u d y  Desi g n  
T his is a pr os pecti ve, u n mas ke d, m ulti -ce nter, si n gle ar m, p ost mar ket st u d y i n a n Asi a n 
p o p ulati o n. B ot h e yes of a s u bject wit h re g ular c or neal asti g m atis m m ust re q uire cataract 
s ur ger y t o q ualif y f or e nr oll me nt i nt o t his st u d y. E ac h site s h o ul d i m pla nt a p pr o xi matel y 5 0 % 
of e yes wit h T F N T 3 0 a n d 5 0 % of e yes wit h T F N T 4 0, T F N T 5 0, a n d T F N T 6 0 c o m bi ne d 
(a p pr o xi matel y at 1: 1 rati o). Sites s h o ul d stri ve t o ha ve at least o ne i m pla nt i n eac h 
asti g matis m le vel  ( T F N T 4 0, T F N T 5 0, a n d T F N T 6 0). 
 
It is rec o m me n de d t hat t h e e ye wit h t he hi g hest asti g matis m is i m pla nte d first. If t he 
asti g matis m is t he sa me i n b ot h e yes, it is at t he s ur ge o n’s discreti o n t o deter mi ne w hic h e ye 
is i m pla nte d first. It is rec o m me n de d t hat t he sec o n d e ye i m pla nt occ urs wit hi n 7 t o 1 4 da ys 
of t he first e ye i m pla nt.  
 
A t otal of 1 0 sc he d ule d visits are pla n ne d i ncl u di n g t he Scree ni n g/ Visit 0 a n d t w o O perati ve 
Visits/ Visit 0 0 a n d Visit 0 0 A. P ost o perati ve visits m ust occ ur at t he f oll o wi n g i nter vals: Da y 
1 -2, Da y 7 -1 4, D a y 3 0 -6 0, Da y 9 0 -1 2 0 a n d Da y 1 8 0 - 2 1 0 (after t he sec o n d e ye s ur ger y).  
 
7. 2  R ati o n ale f or St u d y  Desi g n  
T he test article f or t his st u d y is t he A C R Y S O F I Q Pa n O pti x T oric Trif ocal I O L, m o dels 
T F N T 3 0 -T F N T 6 0. T h e st u d y desi g n ele m e nts are acc or di n g t o sci e ntific sta n dar ds a n d t h e 
d urati o n of f oll o w -u p is a p pr o priate f or t he e v al uati o n of vis ual a n d safet y o utc o mes 
f oll o wi n g rec o ver y a n d sta bilizati o n of visi o n p ost cataract s ur ger y f or a n esta blis he d I O L 
platf or m. T his st u d y will ai m t o e va l uate t he cli nical perf or m a nce of t he A C R Y S O F I Q 
Pa n O pti x T oric Trif ocal I O Ls at M o nt h 3/ Visit 4 A a n d M o nt h 6/ Visit 5 A i n a n Asia n 
p o p ulati o n. T hese res ults will be use d as s u p ple me ntar y cli nical d ata f or a p pr o val of t he 
Pa n O pti x T oric Trif ocal I O Ls i n C hi na or ot her re gi o ns as a p plica ble.  
 
 
 
 
 
 
 
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2 8  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
 
 
7. 3  D at a M o nit ori n g  C o m mittee  
N ot a p plica ble.  
 
8  S T U D Y  P O P U L A TI O N  
T he st u d y p o p ulati o n c o nsists of male a n d fe male s u bjects 2 0 years of a ge a n d ol der t hat self - 
i de ntif y as b ei n g of C hi nese, J a pa nese, K orea n, or M o n g olia n des ce nt, wit h a dia g n osis of 
cataract i n b ot h e yes wit h re g ular c or neal asti g m atis m re q uiri n g s ur ger y wit h i m pla ntati o n of 
a n i ntra oc ular le ns i n t he ca ps ular ba g. It is ai me d t o e nr oll (c o nse nt) a p pr o xi matel y 6 3 
s u bjects ( 1 2 6 e yes) i n a p pr o xi matel y 4-5 si tes i n A ustralia, wit h a tar get of a p pr o xi matel y 
1 3 -1 6  s u bjects per site. Site-s pecific tar gets ma y v ar y b ase d u p o n i n di vi d ual site ca pa bilities. 
Esti mate d ti me nee de d t o recr uit s u bjects f or t he st u d y is a p pr o xi matel y 1 6 wee ks. Ass u mi n g 
a 1 0 % scree ni n g fail ure rate a n d 1 0 % dr o p o ut rate, data fr o m a p pr o xi matel y 5 0 s u bjects 
( 1 0 0 e yes) will be a vaila ble f or statistical a nal ysis at 6 m o nt hs. E nr oll me nt pr ojecti o ns are as 
f oll o ws: 
 
•  
A p pr o xi matel y 6 3 s u bj ects t o be e nr olle d (si g n c o nse nt) (a 1 0 % s cree n fail ure rat e  is 
esti mate d)  
•  
A p pr o xi matel y 5 6 s u bj ects t o be bilaterall y i m pla nte d (a 1 0 % dr o p o ut rate is 
esti mate d)  
•  
Mi ni m u m 5 0 s u bjects t o s uccessf ull y c o m plete t h e fi nal st u d y visit ( M o nt h 6, 
Visit 5 A)  
 
 
 
C hec k all e ntr y criteri a at Scree ni n g/ Visit 0 a n d at b ot h s ur gical visits ( Visit 0 0, Visit 0 0 A).  If 
a s u bject is e x cl u de d f oll o wi n g e nr oll me nt a n d pri or t o 1 st e ye s ur ger y (I O L d oes n ot c o me i n 
c o ntact wit h t he e ye), t he s u bject s h o ul d be disc o nti n ue d fr o m partici pati o n i n t he  st u d y. 
Refer t o Secti o n 8. 3  Reas o ns f or Disc o nti n uati o n ( D uri n g S ur ger y) f or f urt h er details.  
 
8. 1  I ncl usi o n Criteri a  
S u bjects eli gi ble f or i n cl usi o n i n t his st u d y m ust f ulfill 
 t he f oll o wi n g criteria i n b ot h 
e yes ( w h ere a p plica ble):  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 2 9  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1. Asia n A d ults, 2 0 years of a ge or ol der at t he ti me of s ur ger y, dia g n ose d wit h bilateral 
cataracts w h o has pre -e xisti n g re g ular c or neal asti g matis m wit h pla n ne d bilateral 
cataract r e m o val b y p h ac oe m ulsificati o n wit h a clear c or nea i ncisi o n a n d f oll o we d b y 
p osteri or c ha m ber I O L  i m pla ntati o n 
2. A ble  t o c o m pre he n d  a n d  willi n g  t o si g n i nf or me d c o nse nt  a n d  c o m plete  all re q uire d 
p ost o perati ve f oll o w -u p  pr oce d ures  
3. Calc ulate d tar get resi d ual refracti ve err or wit hi n ± 0. 5 D of e m metr o pia wit hi n  t he 
a vaila ble le ns p o w er ra n ge i n b ot h o perati ve  e yes  
4. Pre o perati ve re g ular c or neal kerat o metric asti g matis m wit h pre dicte d resi d u al 
refracti ve asti g matis m ≤ 0. 5 0 D i n b ot h o perati ve  e yes  
 
 
 
 
 
8. 2  E xcl usi o n  Criteri a  
S u bjects f ulfilli n g a n y of t he f oll o wi n g criteria  i n eit her e ye ( w here a p plica ble) are n ot 
eli gi ble f or i ncl usi o n i n t his st u d y:  
 
 
 
2. Cli nicall y si g nifica nt c or neal a b n or malities, e. g., c or neal d ystr o p h y, i nfla m mati o n, 
e de ma, et. al. or c or neal irre g ularit y (i ncl u di n g dr y e ye s y n dr o me) per t he 
i n vesti gat or’s e x pert me dical o pi ni o n or c or neal e n d ot helial cell less t ha n 2 0 0 0/ m m 2; 
N ote: c o n diti o ns i ncl u di n g b ut n ot li mite d t o keratitis, kerat oc o nj u ncti vitis, 
kerat o u veitis or kerate ctasia s h o ul d be e x cl u de d  
3. Hist or y of or c urre nt r eti nal disease, or pre dis p ositi o n t o reti nal disease, or prese nce of 
isc he mic o ptic ne ur o pat h y a n d ot h er reti n o pat h y w hic h ca n lea d t o o ptic atr o p h y, or 
ot her de ge n erat e reti nal disease t hat t he i n vesti gat or j u d ges c o ul d c o nf o u n d st u d y 
o utc o mes; N ote: I ncl u di n g b ut n ot li mit e d t o bac k gr o u n d di a betic reti n o pat h y,  di a betic 
mac ular e d e ma or pr oliferati ve dia betic reti n o pat h y a n d m ac ular  d e ge n erati o n  
 
 
 
 
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 0  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
6. Gla uc o ma ( u n c o ntr olle d or c o ntr olle d wit h me dicati o n) a n d iris/a nteri or c h a m ber 
a n gl e ne o vasc ularizati o n  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11. S u bjects wit h hist or y of pre vi o us refracti ve s ur ger y or c o r neal s ur ger y, or reas o na bl y 
be e x pecte d t o re q uire a oc ular treat me nt/s ur ger y at a n y ti me d uri n g t he st u d y or a n y 
ot her  oc ular  S ur ger y  i n eit her e ye wit hi n  3  m o nt hs  pri or  t o scree n visit  
 
 
 
If t he i m pla ntati o n was a b orte d a n d t he I O L di d n ot t o uc h t he e ye ( 1st e ye), t he n t he s u bject is 
re q uire d t o disc o nti n ue fr o m t he st u d y a n d sta n d ar d of care f or I O L i m pla nt ati o n is f oll o we d. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 1  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
If t he i m pla ntati o n was a b orte d a n d t he I O L di d t o uc h t he e ye ( 1st e ye), t he n t he s u bject is 
e nc o ura ge d t o atte n d all f oll o w -u p st u d y visits f or safet y e v al uati o n o n t his e ye o nl y.  
 
8. 4  Rescree ni n g of  S u bjects  
Rescree ni n g of s u bjects is n ot all o we d i n t his st u d y.  
 
9  T R E A T M E N T S  A D MI NI S T E R E D  
9. 1  I n vesti g ati o n al Pr o d uct(s)  
Test  Pr o d uct(s):  
A C R Y S O F I Q Pa n O pti x T oric  Trif ocal  I ntra o c ular 
Le ns es (I O Ls) ( M o dels: T F N T 3 0, T F N T 4 0,  T F N T 5 0, 
T F N T 6 0)  
C o ntr ol Pr o d uct(s)  (If a p plic a ble):  N ot  a p plica ble  
 
T a ble  9 – 1  
Test  Pr o d uct  
 
Test Pr o d uct  
A C R Y S O F I Q Pa n O pti x T oric Trif ocal I ntra o c ular Le nses (I O Ls) 
( M o dels: T F N T 3 0, T F N T 4 0, T F N T 5 0, T F N T 6 0) 
Ma n ufact ur er  
Alc o n La b orat ories, I nc. 
6 2 0 1 S o ut h Free wa y  
F ort W ort h, Te x as 7 6 1 3 4 -2 0 9 9 
U S A  
I n dic ati o n f or use 
a n d i nte n de d 
p ur p ose i n t he 
c urre nt  st u d y 
T he A C R Y S O F I Q Pa n O pti x T oric Trif ocal I ntra o c ular le ns is 
i n dicate d f or pri mar y i m pla ntati o n i n t he ca ps ular ba g i n t he 
p osteri or c ha m ber of t he e ye f or t h e vis ual c orrecti o n of a p ha kia 
a n d pre-e xisti n g c or neal asti g matis m, i n a d ult patie nts i n w h o m a 
cataract o us le ns has b ee n re m o ve d.  
Pr o d uct descri pti o n 
a n d para m eters 
a vaila ble f or t his 
st u d y 
•  O ptic T y p e: Si n gle -pi ece I O L wit h diffracti ve as p heric  o ptic  
•  O ptics Material: Ultra vi olet li g ht a n d bl ue li g ht  filt eri n g 
Acr ylate/ Met h acr ylat e  C o p ol y mer  
•  O ptic P o wers (s p herical e q ui vale nt di o pters): + 6. 0  t hr o u g h 
+ 3 0. 0 di o pter i n 0. 5 di o pter i ncre me nts; + 3 1. 0 t hr o u g h  
+ 3 4. 0 di o pter i n 1. 0 di o pter i ncre me nts wit h a + 2. 1 7 di o pter 
i nter me diate a n d a + 3. 2 5 di o pter near a d d p o wer 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 2  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
•  I O L C yli n der P o wers:  
 
 
 
 
 
 
 
 
 
a Base d o n a n a v era ge ps e u d o p ha kic h u ma n e ye  
•  I n d e x of Refracti o n: 1. 5 5  
•  Ha ptic C o nfi g urati o n: S T A B L E F O R C E ™ M o difie d -L 
Ha ptics  
•  Ha ptic  Materi al:  Ultra vi olet  li g ht a n d bl ue  li g ht filteri n g 
Acr ylate/ Met h acr ylat e  C o p ol y mer  
•  O ptic Dia meter ( m m):  6. 0  
•  O verall Le n gt h ( m m):  1 3. 0  
•  Ha ptic A n gle:  0°  
F or m ulati o n  
N/ A  
Usa ge  
I O Ls are i m pla nta ble me dical de vices a n d are i nte n de d f or l o n g - 
ter m use o ver t he lifeti me of t he pse u d o p h a kic s u bject. 
N u m ber/ A m o u nt of 
pr o d uct t o be 
pr o vi de d t o t he 
s u bject 
Eac h s u bject will be bilat erall y i m pla nte d wit h t he test articles.  
Pac ka gi n g 
descri pti o n  
Alc o n sta n dar d c o m mercial pac ka ge c o ntai ns bel o w ite ms:  
•  T he I O L  
•  A s u bject re gistrati o n car d i n case it is nee de d f or t he Alc o n 
mar ket ( Le ns I m pl a nt Re pl y  Car d)  
•  A s u bject i de ntificati o n car d, f or t he p atie nt (I m pl a nt  Car d)  
•  A d hesi ve la bels c o nt ai ni n g t he I O L i nf or mati o n a n d u ni q ue 
serial n u m ber  
•  eI F U Refere nce Car d, pr o vi di n g i nf or mati o n t o access t he 
I F U at if u.alc o n.c o m 
Pa n O pti x 
T oric 
Trif ocal 
M o del  
C yli n d er P o wer  
I O L 
Pla ne  
C or neal 
Pla ne a 
T F N T 3 0  
1. 5 0  
1. 0 3  
T F N T 4 0  
2. 2 5  
1. 5 5  
T F N T 5 0  
3. 0 0  
2. 0 6  
T F N T 6 0  
3. 7 5  
2. 5 7  
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 3  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
La b eli n g d escri pti o n  Pac ka ge d i n a sta n d ar d Alc o n I O L cart o n. T he cart o n is la bele d 
wit h t he f oll o wi n g i nf or mati o n: na me of t he le ns, m o del n u m ber, 
o verall dia meter, o ptic dia meter, di o pter p o wer, serial n u m ber, 
na me of t he ma n ufact ur e, st ora ge c o n diti o n, e x pirati o n date, sterile, 
a n d si n gle us e.  
A d diti o nal 
i nf or mati o n 
I n or der t o i m pla nt I O Ls i n st u d y s u bjects, t he s ur ge o ns 
partici pati n g i n t he st u d y m ust be lice nse d o p ht hal m ol o gists wit h 
cataract s ur ger y e x perie n ce a n d tr ai ne d o n t he pr ot oc ol.  
M ore i nf or mati o n o n t he test article ca n be f o u n d i n t he D F U f or 
A C R Y S O F I Q Pa n O pti x T oric Trif o cal I O L ( M o dels: T F N T 3 0, 
T F N T 4 0, T F N T 5 0, T F N T 6 0).  
 
 
9. 2  Ot her Me dic al De vice or Me dic ati o n S pecifie d f or Use d uri n g  t he 
St u d y  
Eac h s ur ge o n will use his/ her sta n dar d of care t o i m pla nt t he le ns f oll o wi n g t he res pecti ve 
I F U i nstr ucti o ns. Alc o n q ualifie d deli ver y s yste ms a n d O V Ds s h o ul d be use d ( per t he I F U). 
 
9. 3  Tre at me nt  Assi g n me nt  
S u bjects will be i m pla nte d bilaterall y wit h Pa n O pti x T oric Trif ocal I O L ( M o dels: T F N T 3 0, 
T F N T 4 0, T F N T 5 0, T F N T 6 0) base d o n t he rec o m me n dati o n of t he A L C O N ® O nli ne T oric 
I O L Calc ulat or wit h t he Barrett T oric Al g orit h m fr o m w w w. m yalc o n -t oriccalc.c o m. 
 
 
 
 
T he i m pla ntati o n of T F N T 2 0 is n ot all o we d per pr ot oc ol.  
 
Eac h site’s e nr oll me nt s h o ul d n ot be m ore t ha n 5 0 % of t he t otal n u m ber of s u bjects e nr olle d 
i n t he st u d y b ut s h o ul d tar get a p pr o xi matel y 2 5 % e nr oll me nt of s u bjects (a p pr o xi matel y 
1 3 -1 6  s u bjects per site i m pla nte d). 
 
O nl y after si g ni n g t he i nf or me d c o nse nt f or m (I C F), will a s u bject be assi g n e d a s u bject 
n u m ber b y t he ele ctr o nic data ca pt ur e ( E D C) s yste m.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 4  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
9. 4  Tre at me nt  M as ki n g  
All me m bers ass ociate d wit h t he st u d y (at t he site a n d t he St u d y S p o ns or) are u n mas k e d t o 
t he assi g n e d treat me nt. Mas ki n g is n ot re q uir e d i n t his st u d y si nc e t here is a si n gle treat me nt 
gr o u p.  
 
Meas ures t o mi ni mize bias i ncl u de o bjecti ve pri mar y e n d p oi nts a n d c o nsist e nt trai ni n g 
pr oce d ures acr oss st u d y sites.  
 
9. 5  Acc o u nt a bilit y  Pr oce d ures  
T hr o u g h o ut t he st u d y, t h e I n vesti gat or or d ele gat e m ust mai ntai n rec or ds of I O Ls i m pla nte d 
f or eac h s u bject. T his r ec or d m ust be ma de a v aila ble t o t he st u d y m o nit or f or t he p ur p oses of 
verif yi n g t he acc o u nti n g st u d y I O Ls i m pla nte d. A n y discre pa n cies a n d/ or d eficie nci es 
bet wee n t he o bs er ve d dis p ositi o n a n d t he writte n acc o u nt m ust be rec or de d al o n g wit h a n 
e x pla nati o n.  
 
Ret ur n t o t he St u d y S p o ns or a n y st u d y I O Ls ass ociate d wit h a de vice defici e nc y. Refer t o 
Secti o n 1 1  of t his pr ot oc ol f or a d diti o nal i nf or mati o n o n t he re p orti n g of de vice defici e ncies 
a n d t o t he M O P f or i nf or mati o n o n ret ur n of st u d y pr o d ucts ass ociate d wit h t hese e ve nts.  
 
T he I n vesti gat or is r es p o nsi ble f or pr o per dis p ositi o n of all u n use d I Ps at t he c o ncl usi o n of 
t he st u d y, acc or di n g t o t h e i nstr ucti o ns pr o vi de d i n t he M O P. 
 
9. 6  C h a n ges t o c o nc o mit a nt me dic ati o ns,  tre at me nts/ pr oce d ures 
After t he s u bject is e nr olle d i nt o t he st u d y, t he I n v esti gat or m ust i nstr uct t h e s u bject t o n otif y 
t he st u d y site a b o ut: 
 
•  
A n y n e w  me dicati o ns  
•  
Alterati o ns i n d ose or d ose sc he d ules f or c urre nt me dicati o ns,  
•  
A n y me di cal pr oce d ure or h os pitalizati o n t hat occ urre d or is  pla n ne d  
•  
A n y n o n -dr u g t hera pies (i ncl u di n g p h ysical t hera p y a n d bl o o d  tra nsf usi o ns). 
T he I n vesti gat or m ust d o c u me nt t his i nf or mati o n i n t he s u bject’s cas e hist or y s o urce 
d oc u me nts.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 5  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 0  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  
T he f oll o wi n g s ecti o n o utli nes t he assess me nts perf or me d i n t his cli nical st u d y. T he 
I n v esti gat or is res p o nsi ble f or e ns uri n g res p o nsi bilities f or all pr oce d ures a n d assess me nts are 
dele gate d t o a p pr o priatel y q ualifie d site pers o n nel.  
 
Assess me nts are d escri be d i n detail i n t he M O P, a n d are o utli ne d i n Ta ble 3 – 1 , Sc he d ule of 
St u d y Pr oce d ures a n d Asse ss me nts. 
 
D uri n g t h e c o urs e of t he st u d y, it is p ossi ble t hat t he wi n d o w of visits ma y o verla p; i n s uc h 
cases t he s u bje ct ma y c o m plete b ot h visits o n t he sa me da y at t he discreti o n of t he 
I n v esti gat or (a n d t h e data w o ul d be e ntere d f or eac h res pecti ve visit i n E D C). 
 
1 0. 1  I nf or me d C o nse nt a n d Scree ni n g  
T he I n vesti gat or or d ele gate m ust e x plai n t he p ur p ose a n d nat ur e of t he st u d y, a n d h a ve t he 
s u bject rea d, si g n, a n d d ate t he I R B/I E C-a p pr o ve d i nf or me d c o nse nt d oc u m e nt. T he s u bject 
m ust si g n t he I C F B E F O R E a n y st u d y -s p ecific pr oce d ures or assess me nts ca n be p erf or m e d, 
i ncl u di n g st u d y-s pecific scree ni n g pr oce d ures. U p o n si g ni n g i nf or me d c o ns e nt, t he s u bject is 
c o nsi dere d e nr olle d i n t he st u d y. ( N ote t hat data fr o m e xa ms a n d assess me nts s pecifie d i n 
Secti o n 1 0. 2. 1  t hat were c o m plete d wit hi n 9 0 da ys of scree ni n g ca n b e use d as per discreti o n 
of I n vesti gat or.)  
 
A d diti o nall y, t he i n di vi d ual o btai ni n g c o ns e nt fr o m t he s u bject a n d a wit ness, if a p plica ble, 
si g n a n d d ate t he i nf or me d c o nse nt doc u me nt. T he s u bject s h o ul d be pr o vi de d wit h e n o u g h 
ti me f or his/ her decisi o n o n partici pati o n i n t he st u d y a n d s h o ul d h a ve o pti o ns t o disc uss wit h 
his/ her fa mil y me m b ers or relati ves a b o ut t he p artici pati o n i n t he i n vesti gati o n.  
 
T he I n vesti gat or or d ele g ate m ust pr o vi de a c o p y of t he si g n e d d oc u me nt t o t he s u bject a n d 
place t he ori gi nal si g ne d d oc u me nt i n t he s u bject’s c hart, or pr o vi d e d oc u me ntati o n as 
re q uire d b y l oc al re g ulati o ns. N ote t hat t he a p plica ble pri vac y re g ulati o n re q uire me nts m ust 
be met.  
 
1 0. 2  V isits a n d  E x a mi n ati o ns  
1 0. 2. 1  Visit 0: Pre o per ati ve Scree ni n g  Visit  
Re vie w n o n -st u d y s pecifi c i ncl usi o n/e xcl usi o n criteria (e g, a ge, pre vi o us oc ular hist or y) t o 
e ns ure t hat a p ot e ntial s u bject meets q ualificati o ns f or partici pati o n i n t he st u d y, pri or t o t he 
st u d y-s pecific scree ni n g re q uire me nt. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 6  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
F or a p ot e ntial s u bject meeti n g all e ntr y criteria vi a pre -s cree ni n g, i n vite hi m/ her t o 
partici pate i n t he st u d y a n d carr y o ut t he i nf or me d c o nse nt pr ocess if he/s he is i ntereste d.  
 
Data fr o m t he I n vesti g at or’s pre vi o us r o uti ne cli nical e val uati o n ma y be us e d a n d t his data 
ma y b e use d fr o m m ore t ha n o ne r o uti ne visit, as l o n g as t h e visits are less t ha n 9 0 da ys ol d 
a n d f ulfill Visit 0 re q uire me nts.  
 
As part of r o uti ne practice, s u bjects w h o are e nr olle d a n d wear c o nt act le ns es m ust 
disc o nti n ue use f or t he a p pr o priate a m o u nt of ti m e t o e ns ure c or neal sta bilit y.  
 
N ote: S u bjects m ust f or mall y c o nse nt t o t he trial pri or t o a n y st u d y -s pecifi c testi n g t hat is n ot 
sta n dar d of care. 
 
1. After t he s u bject si g ns t h e c o nse nt, assess i ncl usi o n/e xcl usi o n criteri a as assess me nts 
are c o m plet e d. T he s u bject m ust meet all i ncl usi o n criteria a n d m ust n ot meet a n y 
e x cl usi o n criteria pri or t o  s ur ger y. 
2. O btai n t he s u bject’s de m o gr a p hic i nf or mati o n (i ncl u di n g a ge, race, et h nicit y, a n d se x) 
a n d c ollect me dic al hist or y i nf or mati o n, i ncl u di n g i nf or m ati o n o n all c o nc o mit a nt 
me dic ati o ns use d wit hi n t he past 3 0 da ys. I ncl u de her bal t hera pies, vita mi ns a n d all 
o ver -t he-c o u nter as well as prescri pti o n me dicati o ns. ( D oc u me nt f ull me dical his t or y 
a n d c o nc o mita nt me dicati o ns i n s o urce t hr o u g h o ut t he st u d y. D oc u me nt all oc ular 
me dical hist or y a n d tar gete d s yste mic me di cal hist or y i n t he st u d y dat a base. Li ke wis e, 
d oc u me nt all oc ular me di cati o ns a n d tar gete d s yste mic me dicati o ns i n t he st u d y 
data b ase. Refer t o M O P f or re p orti n g  re q uir e me nts.) 
3. Perf or m a uri ne pre g n a nc y test , I F t he s u bject is a w o ma n of c hil d beari n g p ote ntial 
o nl y ( defi ne d as all w o me n w h o are p h ysi ol o gicall y ca pa ble of b ec o mi n g pre g na nt a n d 
w h o are n ot p ost me n o pa usal f or at least 1  year or are less t ha n 6 wee ks si n ce 
steriliz ati o n). 
4. C o m plete s u bject q uesti o n n aire : Q U VI D 
 
 
 
5. A dj ust r o o m t o p h ot o pic li g hti n g c o n diti o ns f or dista nce ( 4 m).  
 
 
7. Perf or m m a nif est refr acti o n ( O D, O S).  
8. Meas ure a n d rec or d B C D V A at 4 m ( O D,  O S).  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 7  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
9. Perf or m sli p-l a m p e x a mi n ati o n of t he a nteri or se g me nt of b ot h  e yes.  
10. Meas ure o ptical bi o metr y acc or di n g t o t he I n vesti gat or’s sta n dar d of care n oti n g all 
a vaila ble meas ure me nts i ncl u di n g ker at o metr y , cr ystalli ne le ns t hic k n ess, w hite -t o- 
w hite,  a nteri or c ha m ber  d e pt h  ( A C D) wit h  c or neal  t hic k ness a n d a xial le n gt h ( A L). 
Use sta n dar d of care t o s elect le ns p o wer f or i m pl a ntati o n. It is s u g geste d t o c h o ose t he 
p o wer t hat will res ult i n t he cl osest o utc o me t o e m metr o pia a n d ta r gete d resi d ual 
refracti ve err or m ust be wit hi n ± 0. 5 D of e m metr o pia. Use t he A L C O N® O nli ne T oric 
I O L Calc ulat or wit h t he Barrett T oric Al g orit h m fr o m w w w. m yalc o n -t oriccalc.c o m t o 
scree n s u bjects i n t he st u d y a n d s elect t oric l e ns m o del f or eac h e ye. C h o ose t he t oric 
m o del ( T F N T 3 0, T F N T 4 0, T F N T 5 0, or T F N T 6 0) t hat res ults i n t he least a m o u nt of 
resi d ual asti g m atis m t hat is wit hi n 0. 5 D. If t he m o del wit h t he least resi d u al 
asti g matis m re q uir es fli p pi n g t h e a xis, it is t he s ur ge o n’s c h oice t o use t hat m o del or 
t he ne xt m o del t hat all o ws t he l o west resi d ual asti g matis m wit h o ut fli p pi n g t he a xis, as 
l o n g as t he res ult is still wit hi n 0. 5 D. I m pla ntati o n of a T F N T 2 0 i n t he st u d y is n ot 
all o we d.  
D oc u me nt t he s ubje ct’s re q uire d le ns p o wer a n d m o del ( Pa n O pti x T oric Trif ocal 
T F N T 3 0, T F N T 4 0, T F N T 5 0, or T F N T 6 0) f or eac h e ye. D oc u m e nt t he 
pre dicte d/tar gete d resi d ual refracti ve err or ( T R R E), t he pre dict e d resi d ual refracti ve 
c yli n der a n d i nte n de d a xis place me nt f or eac h e ye base d o n t he selecte d le ns p o wer 
a n d m o del.  
 
12. Perf or m a dil ate d f u n d us e x a mi nati o n of b ot h  e yes. 
13. Rec or d a n y a d verse  e ve nts. 
 
 
16. E ns ure t hat all i ncl usi o n/e x cl usi o n criteria ha ve b ee n met a n d t hat all pre o perati ve 
scree ni n g assess me nts ha ve bee n p erf or m e d. U p o n meeti n g eli gi bilit y criteria, s u bjects 
will be sc he d ule d f or  s ur ger y. 
1 0. 2. 2  Visit 0 0: S ur ger y Visit 1 st E ye  
It is rec o m me n de d t hat s ur ger y occ ur as s o o n after scree ni n g as p ossi ble or wit hi n 3 0 da ys of 
t he scree ni n g visit. 
 
1. Rec or d O per ati ve  e ye. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 8  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
2. Rec or d c o nc o mit a nt me dic ati o ns f or oc ular a n d n o n-oc ular  c o n diti o ns.  
3. Verif y i ncl usi o n/e xcl usi o n criteri a. S u bjects m ust meet all re q uire m e nts t o pr ocee d t o 
s ur ger y. 
4. Pre pare  s u bject f or s ur ger y i n acc or da nce  t o site s p ecific o perati n g  pr oce d ures  a n d 
e ns ure t hat all I O L p o wer calc ulati o ns ha v e bee n  c o m plete d.  
5. Perf or m s ur ger y a n d i m pl a nt ati o n wit h t he I O L  t o w hic h t he s u bject was calc ulate d 
t o recei ve p er t he A L C O N® O nli ne T oric I O L C alc ulat or wit h t he Barrett T oric 
Al g orit h m.  
6. Rec or d a n y s ur gic al pr o ble ms, c o m plic ati o ns or ot her pr oce d ures (i n cl u di n g  S SIs) 
t hat occ urre d d uri n g s ur ger y. Ot her pr o ce d ures i ncl u de  t h ose perf or me d o utsi de of 
r o uti ne cataract s ur ger y. Ot her pl a n ne d pr oce d ures at t he ti me of s ur ger y are 
e xcl usi o n ar y.  
7. Rec or d fi n al i ncisi o n size a n d i ncisi o n l oc ati o n. 
8. Rec or d le ns i nf or m ati o n t hat is l ocate d o n t he I O L stic ker. B ot h s uccessf ul a n d 
a b orte d (if a p plica ble) t est article i nf or mati o n s h o ul d be  rec or de d. 
 
 
 
10. Rec or d a n y a d verse  e ve n ts. 
 
1 0. 2. 3  Visit 1: P ost o per ati ve f or 1 st  E ye ( 1 -2 D a ys after Visit  0 0)  
1. Rec or d c o nc o mit a nt me dic ati o ns f or oc ular a n d n o n-oc ular  c o n diti o ns.  
2. A dj ust r o o m t o p h ot o pic li g hti n g c o n diti o ns f or dista nce ( 4 m).  
 
 
 
 
 
4. Perf or m slit-l a m p e x a mi n ati o n of t he a nteri or  se g me nt. 
 
 
 
 
7. Rec or d t he act u al a xis of I O L  orie nt ati o n . 
 
. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 3 9  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
9. Rec or d sec o n d ar y s ur gi c al i nter ve nti o ns t hat ha ve occ urre d si nce s ur ger y, if 
a p plica ble.  
10. Rec or d a n y a d verse  e ve nts. 
. 
1 0. 2. 4  Visit 2: P ost o per ati ve f or 1 st  E ye ( 7 -1 4 D a ys after Visit  0 0)  
1. Rec or d c o nc o mit a nt me dic ati o ns f or oc ular a n d n o n-oc ular  c o n diti o ns.  
2. A dj ust r o o m t o p h ot o pic li g hti n g f or dist a nce at 4 m.  
 
 
4. Perf or m  m a nif est  refr acti o n  at 4  m.  
 
 
 
 
6. Perf or m slit-l a m p e x a mi n ati o n of t he a nteri or  se g me nt. 
 
 
 
 
 
 
10. Perf or m a dil ate d f u n d us  e x a mi n ati o n.  
11. Rec or d sec o n d ar y s ur gi c al i nter ve nti o ns t hat ha ve occ urre d si nce s ur ger y, if 
a p plica ble.  
12. Rec or d a n y a d verse e v e nts ( b ot h v ol u nteere d a n d elicite d). 
 
1 0. 2. 5  Visit 0 0 A: S ur ger y Visit 2 n d E ye (rec o m me n de d 7 -1 4 D a ys after Visit 
0 0)  
F oll o w all pr oce d ures liste d i n Secti o n 1 0. 2. 2 f or t he 2 n d o perati ve e ye.  
 
1 0. 2. 6  Visit 1 A: P ost o per ati ve f or 2 n d E ye ( 1 -2 D a ys after Visit  0 0 A)  
F oll o w all pr oce d ures liste d i n Secti o n 1 0. 2. 3 f or t he 2 n d  o perati ve e ye.  
 
1 0. 2. 7  Visit 2 A: P ost o per ati ve f or 2 n d E ye ( 7 -1 4 D a ys after Visit  0 0 A)  
F oll o w all pr oce d ures liste d i n Secti o n 1 0. 2. 4 f or t he 2n d  o perati ve e ye.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 0  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 0. 2. 8  Visit 3 A: P ost o per ati ve f or B ot h E yes ( 3 0 -6 0 D a ys after Visit  0 0 A)  
1. Rec or d c o nc o mit a nt me dic ati o ns f or oc ular a n d n o n-oc ular  c o n diti o ns.  
2. A dj ust r o o m t o p h ot o pic li g hti n g c o n diti o ns f or dist a nce at 4 m.  
 
 
. 
4. Perf or m m a nif est refr acti o n at 4 m f or eac h e ye. 
 
 
 
 
 
 
 
 
 
 
 
 
8. Perf or m slit-l a m p e x a mi n ati o n of t he a nteri or se g me nt f or eac h  e ye.  
 
 
 
. 
 
 
 
14. Perf or m a dil ate d f u n d us e x a mi n ati o n f or eac h e ye.  
15. Rec or d sec o n d ar y s ur gi c al i nter ve nti o ns t hat ha ve occ urre d si nce s ur ger y, if 
a p plica ble.  
16. Rec or d a n y a d verse e v e nts ( b ot h v ol u nteere d a n d elicite d). 
 
1 0. 2. 9  Visit 4 A: P ost o per ati ve f or B ot h E yes ( 9 0 -1 2 0 D a ys after Visit  0 0 A)  
1. C o m plete s u bject q uesti o n naire  at t he b e gi n ni n g of t he visit pri or t o a n y ot her  testi n g: 
Q U VI D 
 
2. Rec or d c o nc o mit a nt me dic ati o ns f or oc ular a n d n o n-oc ular  c o n diti o ns.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 1  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
3. A dj ust r o o m t o p h ot o pic li g hti n g c o n diti o ns f or dist a nce at 4 m.  
 
 
 
5. Perf or m m a nif est refr acti o n at 4 m f or eac h e ye. 
 
 
6. Meas ure 
 bi n oc ular B C D V A at 4 m i n p h ot o pic li g hti n g  c o n diti o ns. 
 
 
8. A dj ust e q ui p me nt f or i nter me diate assess me nt at 6 0 c m, meas ure 
 
bi n oc ular  D CI V A ( wit h -0. 2 5 D S P H p o wer f or best dista nce c orrecti o n) i n  p h ot o pic 
li g hti n g c o n diti o ns.  
9. A dj ust e q ui p me nt f or near assess me nt at 4 0 c m, m eas ure 
 bi n oc ular 
D C N V A ( wit h -0. 2 5 D S P H p o wer f or best dista nce c orrecti o n) i n p h ot o pic li g ht 
c o n diti o n.  
 
 
 
 
13. Perf or m slit-l a m p e x a mi n ati o n of t he a nteri or  se g me nt. 
 
. 
16. Rec or d t he act u al a xis of I O L  orie nt ati o n . 
 
 
 
 
20. Perf or m a dil ate d f u n d us e x a mi n ati o n f or eac h e yes.  
21. Rec or d sec o nd ar y s ur gi c al i nter ve nti o ns t hat ha ve occ urre d si nce s ur ger y, if 
a p plica ble.  
22. Rec or d a n y a d verse e v e nts ( b ot h v ol u nteere d a n d elicite d). 
. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 2  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 0. 2. 1 0  Visit 5 A: P ost o per ati ve f or B ot h E yes ( 1 8 0 -2 1 0 D a ys after V isit 0 0 A)  
F oll o w all pr oce d ures liste d i n Secti o n 1 0. 2. 9 f or eac h e ye A N D meas ure o ptical bi o metr y, 
acc or di n g t o t he I n vesti gat or’s sta n dar d of care ( use d at Visit 0), n oti n g all a vaila ble 
meas ure me nts i ncl u di n g ker at o metr y , w hite-t o-w hite, a nteri or c h a m ber d e pt h ( A C D) wit h 
c or neal t hic k n ess a n d a xial le n gt h ( A L).  
 
1 0. 2. 1 1  U nsc he d ule d  Visit  
If a s u bject is e x a mi ne d m ore t ha n o nce d uri n g a n y of t he s c he d ule d f oll o w-u p peri o ds, or 
bet wee n sc h e d ule d f oll o w -u p peri o ds d ue t o a p ote ntial iss ue, a n u nsc he d ul e d visit f or m 
s h o ul d be c o m plete d, re p orti n g a n y st u d y para met ers or a n y rele va nt data c ollecte d at t his 
visit. If, d uri n g t he visits s pecific f or t he sec o n d e ye, a cli nical o bser vati o n is ma de o n t he 
first e ye i m pla nte d, a n u nsc he d ule d visit f or m s h o ul d be co m plete d t o rec or d t he first e ye 
data. T he f oll o wi n g e x a ms a n d assess me nts are rec o m me n de d a n d s h o ul d be c o m plete d per 
t he I n v esti gat or’s e x pert o pi ni o n; i n t he e ve nt t his is n ot p ossi ble, t he data t hat is a vaila ble 
s h o ul d be re p orte d. 
1. C o m plete s u bject q ue sti o n n aires at t he be gi n ni n g of t he visit: Q U VI D 
 
q uesti o n naire .  
2. Rec or d c o nc o mit a nt me dic ati o ns f or oc ular a n d n o n-oc ular  c o n diti o ns.  
 
 
4. Perf or m m a nif est refr acti o n at 4 m.  
 
 
6. Perf or m slit-l a m p e x a mi n ati o n of t he a nteri or se g me nt of b ot h  e yes.  
 
 
 
 
9. Rec or d t he act u al  a xis of I O L  orie nt ati o n . 
 
11. Perf or m a dil ate d f u n d us e x a mi n ati o n f or eac h e yes.  
12
 
 
13. Rec or d sec o n d ar y s ur gi c al i nter ve nti o ns f or t he o perati ve e ye(s) t h at ha ve occ urre d 
si nce s ur ger y, if a p plica bl e.  
14. Rec or d a n y a d verse e v e nts ( b ot h v ol u nteere d a n d elicite d). 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 3  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
 
 
 
 
1 0. 3  Disc o nti n ue d  S u bjects  
1 0. 3. 1  Scree n  F ail ures  
S u bjects w h o w ere e x cl u de d fr o m t he st u d y after si g ni n g t he i nf or me d c o nse nt a n d pri or t o 
a d mi nisteri n g treat me nt are c o nsi dere d scree n fail ures. T he I n vesti gat or m ust d oc u me nt t he 
reas o n f or scree n fail ure i n t he s u bject’s cas e hist or y s o urce d o c u me nts. 
 
S u bject n u m bers m ust n ot be re -use d.  
 
1 0. 3. 2  Disc o nti n u ati o ns  
Disc o nti n ue d s u bjects are i n di vi d uals w h o v ol u ntaril y wit h dr a w or are wit h dra w n fr o m t he 
st u d y b y t he I n v esti gat or after i nf or me d c o nse nt is si g ne d a n d bef ore t he last visit is 
c o m plete d.  
 
S u bject n u m bers of disc o nti n ue d s u bjects m ust n ot be re -us e d.  
 
S u bjects ma y disc o nti n ue fr o m t he st u d y or st u d y treat me nt at a n y ti me f or a n y reas o n. 
S u bjects ma y als o b e disc o nti n ue d fr o m st u d y treat me nt at a n y ti me if, i n t he o pi ni o n of t he 
I n v esti gat or, c o nti n ue d tr eat me nt p oses a ris k t o t h eir healt h. 
 
If a s u bject disc o nti n ues fr o m st u d y tr eat me nt, e ver y eff ort m ust be ma de t o kee p t he s u bject 
i n t he st u d y a n d t o c o nti n ue wit h t he st u d y assess me nts, as s pecifi e d i n t he sc he d ule of st u d y 
pr oce d ures a n d ass ess me nts u ntil t he fi nal visit.  
 
T he I n vesti gat or m ust d o c u me nt t he reas o n f or st u d y or treat me nt disc o nti n uati o n i n t he 
s u bject’s cas e hist or y s o urce d oc u m e nts. 
 
T o e ns ure t he s afet y of all s u bjects w h o disc o nti n ue earl y, I n vesti gat ors m ust assess eac h 
s u bject a n d, if necessar y, a d vise t he m of a n y t hera pies a n d/ or me dical pr o ce d ures t hat ma y b e 
nee de d t o mai ntai n t heir healt h.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 4  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 0. 3. 3  Sc he d ule  of  Pr oce d ures  a n d  Assess me nts  f or S u bjects  Disc o nti n ue d 
fr o m I n vesti g ati o n al Pr o d uct  
S u bjects w h o disc o nti n ue t he I P (i e, ha ve st u d y le ns e x pla nte d) will c o nti n ue i n t he st u d y 
t hr o u g h Visit 5 A a n d b e f oll o we d f or safet y. At mi ni m u m, safet y e x a mi nati o ns m ust i ncl u de 
t he assess me nts ass ociate d wit h a p pr o priate me di cal care. Sta n dar d p ost-s ur gical assess me nts 
are b ullete d b el o w:  
•  
U C D V A a n d/ or B C D V A  
•  
Slit -la m p E x a mi nati o n  
•  
Dilate d F u n d us E x a mi nati o n  
1 0. 3. 4  S u bject L ost t o F oll o w  U p  
If a s u bject u n a v oi da bl y misses a sc he d ule d e x a m, he/s he s h o ul d be res c he d ule d wit hi n t he 
sa me e x a m peri o d. T he i n vesti gati o nal site s h o ul d s h o w dili ge nce i n tr yi n g t o sc he d ule t he 
s u bject f or all e x a ms. T he site m ust d oc u me nt all atte m pts t o c o ntact t he s u bject i n t he 
s u bject’s c hart, i ncl u di n g dates, ti mes, met h o d of c o ntact, etc. If a s u bject is u na ble t o ret ur n 
f or t he Fi n al St u d y Visit, t he E xit Case Re p ort F or m s h o ul d be c o m plete d wit h the 
a p pr o priate reas o n f or disc o nti n uati o n i n dicate d. If atte m pts t o c o ntact t he s u bject are 
u ns uccessf ul, t he n t he E xit Case Re p ort F or m f or t hat s u bject is c o m plete d after t he l ast 
wi n d o w cl oses a n d d oc u me nte d as L ost t o F oll o w -u p. T he date at w hic h t h e s u bject was 
c o nsi dere d l ost t o f oll o w -u p s h o ul d als o be rec or de d.  
1 0. 4  S u bject Pre g n a nt or  L act ati n g  
S u bjects w h o bec o me pre g n a nt after ha vi n g a st u d y I O L i m pla nte d ( or t he st u d y I O L t o u c hes 
t he e ye) or are lactati n g d uri n g t he st u d y will n ot be disc o nti n ue d; h owe ver, all data fr o m t hat 
p oi nt f or war d will be e x cl u de d fr o m t he B A S a nal ys es b eca us e t hese c o n diti o ns ca n alter 
refracti o n a n d vis ual a c uit y res ults. Pre g n a nc y, or w o me n w h o are lactati n g, s h o ul d be n ote d 
wit hi n t he s o urce d oc u m e ntati o n f or eac h visit, a n d at w hic h ti me t he s u bject is pre g na nt or 
lactati n g. 
T he I n vesti gat or m ust n otif y t he s p o ns or wit hi n 2 4 h o urs of lear ni n g t hat a s u bject is 
pre g na nt; re p orti n g pr oce d ures are n ote d i n Secti o n 1 1. 9 . 
1 0. 5  Cli nic al St u d y  Ter mi n ati o n  
T he St u d y S p o ns or res er ves t he ri g ht t o cl ose t he i n vesti gati o nal site or ter mi nate t he st u d y i n 
its e ntiret y at a n y ti me. 
If t he cli nical st u d y is pre mat urel y t er mi nate d or s us pe n de d b y t he St u d y S p o ns or: 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 5  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
•  
T he St u d y S p o ns or  m ust:  
o  I m me diat el y n otif y t he I n vesti gat or(s) a n d s u bs e q ue ntl y pr o vi d e 
i nstr ucti o ns f or st u d y ter mi nati o n. 
o  I nf or m t he I n v esti gat or a n d t he re g ulat or y a ut h orities of t he 
ter mi nati o n/s us pe nsi o n a n d t he reas o n(s) f or t h e ter mi nati o n/s us pe nsi o n. 
•  
T he I n vesti gat or  m ust : 
o  Pr o m ptl y n otif y t he I R B/I E C of t h e ter mi nati o n or s us pe nsi o n a n d of t he 
reas o ns. 
o  Pr o vi de s u bjects wit h rec o m me n dati o ns f or p ost -st u d y treat me nt o pti o ns 
as nee d e d.  
T he I n vesti gat or ma y t er mi nate t he site’s partici p ati o n i n t he st u d y f or reas o na ble ca us e.  
 
1 0. 5. 1  F oll o w -u p of s u bjects after st u d y p artici p ati o n h as  e n de d 
F oll o wi n g t his st u d y, t h e s u bject will ret ur n t o t heir e ye care pr ofessi o nal f or t heir r o uti ne e ye 
care.  
 
1 0. 6  C o nti n ge nc y Me as ures  
T o o verc o me c halle n ges t hat ma y arise d uri n g u ne x pecte d e ve nts w hic h c o ul d i nterr u pt t he 
c o n d uct of t he trial as pla n ne d (e g, nat ural disasters or a p u blic healt h e m er ge n c y), 
c o nti n ge n c y meas ures m a y b e i m ple me nte d. T he i nte nt of c o nti n ge nc y meas ures w o ul d be t o 
a d dress t he care of e nr olle d s u bjects d uri n g s uc h  u ne x pecte d e ve nts. It is n ot e x pecte d t hat 
c o nti n ge n c y meas ures w o ul d affect st u d y desi g n; h o we ver, if n ecessar y, t h e pr ot oc ol w o ul d 
be a me n de d acc or di n gl y. Writte n n otificati o n descri bi n g t hese c o nti n ge nc y meas ures will be 
pr o vi de d t o t he I R B a n d ot her r e g ulat or y a ge n cies, as a p plica ble. D uri n g s uc h e ve nts, 
I n v esti gat ors m ust c o nti n ue t o use me dical j u d ge m e nt i n t he care of s u bjects a n d f oll o w 
nati o nal a n d l ocal g ui da n ce, as w ell as I R B re p orti n g re q uire me nts. A d diti o nal i nf or mati o n 
ca n be f o u n d i n t he M O P.  
 
1 1  A D V E R S E E V E N T S A N D D E VI C E  D E FI CI E N CI E S  
1 1. 1  Ge ner al  I nf or m ati o n 
A n a d vers e e ve nt ( A E) is a n y u nt o w ar d me dical o cc urre nce, u ni nte n de d disease or i nj ur y, or 
u nt o war d cli nical si g ns (i ncl u di n g a b n or mal la b orat or y fi n di n gs) i n s u bjects, users, or ot her 
pers o ns,  w het her or n ot r elate d t o t he i n vesti gati o nal me dical de vice (test pr o d uct).  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 7  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
•  
C yst oi d mac ular  e de ma  
•  
H y p o p y o n  
•  
E n d o p ht hal mitis  
•  
Le ns disl oc ati o n fr o m p osteri or  c ha m ber  
•  
P u pillar y  bl o c k  
•  
Reti nal  detac h me nt  
•  
Sec o n dar y s ur gi cal i nter v e nti o n (e x cl u di n g P osteri or  Ca ps ul ot o m y)  
A n y ot her p ote ntiall y si g ht -t hreate ni n g e v e nt ma y als o be c o nsi dere d seri o us base d o n t he 
j u d g me nt of t he I n vesti gat or a n d m ust be re p orte d a p pr o priatel y as deli neat e d i n Secti o n 1 1. 4 . 
 
1 1. 2. 1  De vice  Deficie ncies  
A de vice d eficie n c y ma y or ma y n ot be ass ociat e d wit h s u bject har m (ie, A D E or S A D E); 
h o we ver, n ot all A D Es or S A D Es are d u e t o a de vice defici e nc y. T he I n vesti gat or s h o ul d 
deter mi ne t he a p plica ble cate g or y f or t he i de ntifie d or s us pect de vice  defi cie nc y a n d re p ort 
a n y s u bject har m se p aratel y. E x a m ples of de vice deficie nci es i ncl u de t he f oll o wi n g:  
•  
Fail ure t o meet pr o d uct s pecificati o ns (e g, i nc orrect  I O L p o w er) 
•  
I O L defect  
•  
Br o ke n I O L  o ptic  
•  
Br o ke n I O L  h a ptic  
•  
Scratc he d I O L  o ptic  
•  
U nseale d de vi ce pac ka gi n g  
•  
S us pect pr o d uct c o nta mi nati o n  
•  
Lac k of  effecti ve ness  
1 1. 3  M o nit ori n g  f or A d verse  E ve nts  
At eac h visit, after t he s u bject has ha d t he o p p ort u nit y t o s p o nta ne o usl y me nti o n a n y 
pr o ble ms, t he I n vesti gat or s h o ul d i n q uire a b o ut A Es b y as ki n g sta n d ar d q uesti o ns s uc h as: 
 
•  
“ Ha ve y o u h a d a n y h ealt h pr o ble ms si nce y o ur last st u d y  visit? ”  
•  
“ Ha ve t h ere b ee n a n y c h a n ges i n t he me dici nes y o u ta ke si nce y o ur l ast st u d y  visit? ”  
C ha n ges i n a n y pr ot oc ol -s pecific oc ul ar or s yste mic para met er e v al uate d d uri n g t he st u d y are 
t o be re vie we d b y t he I n v esti gat or. A n y u nt o war d ( u nfa v ora ble a n d u ni nte n de d) c ha n ge i n a 
pr ot oc ol -s pecifi c para meter t hat is cli nicall y rele va nt, i n t he o pi ni o n of t he I n v esti gat or, is t o  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 8  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
be re p ort e d as a n A E. T h ese cli nicall y rel e va nt c ha n ges will be re p orte d re gar dless of 
ca usalit y.  
 
1 1. 4  Pr oce d ures f or Rec or di n g a n d  Re p orti n g  
A Es are c ollecte d fr o m t he ti me of i nf or me d c o ns e nt. A n y pre -e xisti n g me dical c o n diti o ns or 
si g ns/s y m pt o ms pres e nt i n a s u bject pri or t o t he st art of t he st u d y (ie, b ef ore I C F is si g n e d) 
are n ot c o nsi dere d A Es i n t he st u d y a n d s h o ul d be rec or de d i n t he Me dical Hist or y secti o n of 
t he e C R F. 
 
I n a d diti o n, a q ue o us cells a n d flare, c or neal e de ma, raise d I O P a n d s u p erfici al p u nctate 
keratitis are e x a m ples of earl y p ost -o perati ve fi n di n gs t hat are t y picall y o bs er ve d f oll o wi n g 
oc ular s ur ger y. T hes e are n ot c o nsi dere d A Es if t h e y ca n b e reas o na bl y e x pecte d t o res ol v e 
wit hi n a wee k a n d n ot r es ult i n a n y u nt o war d l o n g ter m vis ual o utc o me i m pact.  
 
F or eac h rec or de d e v e nt, t he A D Es a n d S A Es  d oc u me ntati o n m ust i ncl u de: date of 
occ urre nce, se verit y, tr eat me nt (if a p plica ble), o ut c o me, a n d ass ess me nts of t he seri o us ness 
a n d ca usalit y. I n a d diti o n, t he I n v esti gat or m ust d oc u me nt all de vice d eficie ncies re p ort e d or 
o bser ve d wit h test a n d c o ntr ol articles o n t he De vi ce Deficie nc y e C R F. T he site m ust s u b mit 
all a vaila ble i nf or mati o n o n A D Es, S A Es a n d de vi ce defi cie ncies t o t he St u d y S p o ns or 
i m me diatel y as f oll o ws: 
 
•  
A D Es or S A Es are d oc u me nte d o n t he A dvers e Device Effect a n d Seri o us  A dverse 
Eve nt e CR F wit hi n 2 4 h o urs of t he I n vesti gat or’s or site’s  a ware ness.  
•  
A D Es t hat d o n ot meet seri o us ness criteria a n d d e vice defici e ncies m ust be re p orte d 
wit hi n 1 0 cale n dar da ys of t he I n vesti gat or’s or site’s  a ware n ess.  
•  
A  pri nte d  c o p y of  t he c o m plete d Seri o us  A d verse  E ve nt  a n d  A d verse  De vice  Effect 
a n d/ or De vic e Deficie nc y e C R F m ust be i ncl u d e d wit h pr o d uct  ret ur ns. 
•  
A d diti o nal  rele va nt i nf or mati o n after i nitial re p orti n g is t o be  e ntere d i nt o t he e C R F as 
s o o n as t he data bec o me a vaila ble.  
•  
D oc u me nt  a n y c h a n ges  t o c o nc o mita nt  me dicati o ns  o n  t he a p pr o priate e C R Fs.  
•  
D oc u me nt all rele v a nt i nf or mati o n fr o m Disc har ge S u m mar y, A ut o ps y Re p ort, 
Certificate of Deat h et c., if a p plica ble, i n narrati ve secti o n of t he A d verse  De vice 
Effect (f or relate d A Es) a n d Seri o us A d verse  E v e nt  e C R F. 
N O T E : S h o ul d t he E D C s yste m bec o me n o n -o p erati o nal, t he site m ust c o m plete t he 
a p pr o priate p a per A d vers e Devic e Effect a n d Seri o us A dverse Eve nt F or m or Device 
Deficie ncy F or m . T he c o m plete d f or m is e maile d t o t he St u d y S p o ns or at 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 4 9  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
M S U S.safet y @ alc o n.c o m  wit hi n 2 4 h o urs of t he I n v esti gat or’s or site’s a ware n ess; h o we ver, 
t he re p orte d i nf or mati o n m ust be e ntere d i nt o t he E D C s yste m o nce it bec o mes o perati o nal. 
 
St u d y S p o ns or re prese nt at i ves a n d t heir c o nt act i nf or m ati o n are pr o vi de d i n t he 
M a n u al of Pr oce d ures t h at acc o m p a nies t his pr ot oc ol.  
 
F urt her, de pe n di n g u p o n t he nat ure of t h e A E or de vice deficie nc y b ei n g re p orte d, t he St u d y 
S p o ns or ma y re q uest c o pies of a p plica ble p orti o ns of t he s u bject’s me dical rec or ds. T h e 
I n v esti gat or m ust als o re p ort all A Es a n d de vice d eficie nci es t hat c o ul d ha ve le d t o a S A D E 
acc or di n g t o t he re q uire me nts of re g ulat or y a ut h orities or I E C/I R B.  
 
1 1. 5  I nte nsit y a n d C a us alit y Assess me nts  
W here a p pr o pri ate, t he I n vesti gat or m ust assess t he i nte nsit y (se v erit y) of t he A E as mil d, 
m o derate, or s e vere base d o n me dical j u d g m e nt wit h c o nsi derati o n of a n y s u bjecti ve 
s y m pt o m(s), as d efi ne d b el o w: 
 
1 1. 5. 1  I nte nsit y ( Se verit y) 
Mil d  
A n  A E  is mil d  if t he s u bject is a ware of  b ut  ca n easil y t olerat e t he si g n or 
s y m pt o m. 
 
M o der ate  
A n  A E  is m o derate  if t he si g n or  s y m pt o m res ults i n disc o mf ort  si g nifica nt 
e n o u g h t o ca use i nterfere nce wit h t he s u bject’s us ual  acti vities.  
 
Se vere  
A n A E is se vere if t he si g n or s y m pt o m is i nca pacitati n g a n d  res ultsi n t he 
s u bject’s i na bilit y t o w or k or e n ga ge i n t heir us ual acti vities. 
 
1 1. 5. 2  C a us alit y  
F or e v er y A E i n t he st u d y, t he I n v esti gat or m ust assess t he ca usalit y ( Relat e d or N ot Relate d 
t o t he me dical de vice or t est pr oce d ure). A n assess me nt of ca usalit y will als o be perf or me d 
b y t he St u d y S p o ns or utilizi n g t he sa me defi niti o ns, as s h o w n bel o w:  
 
Rel ate d  
A n A E classifie d as relat e d ma y be eit her defi nitel y relate d or  p ossi bl y  relat e d 
w here a direct ca use a n d effect relati o ns hi p wit h t he me dical de vice or s t u d y 
pr oce d ure has n ot bee n d e m o nstrate d, b ut t here is a reas o n a ble p ossi bilit y  t hat 
t he A E  w as  ca use d  b y  t he me dical  de vi ce  or  st u d y pr oce d ure.  
 
N ot  Rel at e d  A n A E classifie d as n ot relate d ma y eit her be defi nitel y u nrel ate d  or si m pl y 
u nli kel y  t o be  relat e d (ie, t here are ot her  m ore  li kel y ca uses  f or t he A E).  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 0  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
T he St u d y S p o ns or will assess t he A Es a n d ma y u p gra de t he I n vesti gat or’s assess me nt of 
seri o us ness a n d/ or ca usalit y. T he St u d y S p o ns or will n otif y t he I n vesti gat or of a n y A Es t hat i s 
u p gra de d fr o m n o n -seri o us t o seri o us or fr o m u nr elate d t o relat e d. 
 
1 1. 6  Ret ur n Pr o d uct  A n al ysis  
St u d y S p o ns or re prese ntati ves a n d t heir c o ntact i nf or mati o n are pr o vi d e d i n t he M O P t hat 
acc o m pa ni es t his pr ot oc ol.  
 
Rec o vera ble Alc o n Pr o d ucts ass ociate d wit h de vi ce defi cie ncies a n d/ or pr o d uct relate d A Es 
s h o ul d be ret ur ne d t o t he S p o ns or wit h t he a p pr o priate ret ur n f or ms. 
 
1 1. 7  U n m as ki n g of t he St u d y  Tre at me nt  
N ot a p plica ble; t his st u d y is o pe n -l a bel, u n mas ke d st u d y. 
 
1 1. 8  F oll o w -U p  of  S u bjects  wit h  A d verse  E ve nts  
T he I n vesti gat or is r es p o nsi ble f or a de q u ate a n d s afe me dical care of s u bjects d uri n g t he 
st u d y a n d f or e ns uri n g t h at a p pr o priat e me dical care a n d rele va nt f oll o w -u p pr oce d ures are 
mai ntai ne d after t h e st u d y.  
 
T he I n vesti gat or m ust pr o vi de t he St u d y S p o ns or wit h a n y n e w safet y i nf or mati o n ( w hic h 
i ncl u des ne w A Es a n d c h a n ges t o pre vi o usl y re p orte d A Es) t hat ma y affect t he safet y 
e val uati o n of t he de vi ce. F or A Es t hat are u nres ol ve d/ o n g oi n g at ti me of s u bject e xit fr o m 
st u d y, a n y a d diti o nal i nf or mati o n recei ve d at f oll o w-u p s h o ul d be d oc u me nte d i n t he e C R Fs 
u p t o st u d y c o m pleti o n (i e, data bas e l oc k).  
 
All c o m plai nts recei ve d after t his ti me peri o d will be c o nsi dere d a n d pr o cesse d as 
s p o nta ne o us (f oll o wi n g t he p ost mar ket vi gila nce pr oce d ures) a n d s h o ul d b e c o m m u n icate d t o 
t he me dical de vice’s ma n ufact ur er as p er l ocal re q uire me nts. 
 
1 1. 9  Pre g n a nc y i n t he Cli nic al  St u d y  
Pre g n a nc y is n ot re p orta ble as a n A E; h o w e ver, c o m plicati o ns ma y be re p orta ble a n d will be 
deci de d o n a case -b y -cas e basis. A n Alc o n f or m will be utiliz e d t o ca pt ure all pre g na nc y- 
relate d i nf or m ati o n u ntil birt h of t he c hil d. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 1  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 2  A N A L Y SI S  P L A N  
1 2. 1  S u bject  E v al u a bilit y  
S u bject e val ua bilit y will be deter mi ne d pri or t o t he 
 
fi nal data bas e l oc k, base d u p o n t he De viati o ns a n d E val ua bilit y Pla n ( D E P).  
 
1 2. 2  A n al ysis  Sets  
T he Safet y A n al ysis Set ( S S) will i ncl u de all e yes wit h atte m pte d I O L i m pla ntati o n 
(s uccessf ul or a b ort e d aft er c o nta ct wit h t he e ye). T he S S will be t he pri mar y s et f or all safet y 
a nal ys es.  
 
All -I m plant e d A nal ysis Set ( A A S) i ncl u des all e yes wit h s uccessf ul I O L i m pla ntati o n wit h at 
least o ne p ost-o perati ve visit a n d will be t he pri mar y a nal ysis set f or all effecti ve ness 
a nal ys es 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 2. 3  De m o gr a p hic a n d B aseli ne  C h ar acteristics  
De m o gra p hics a n d baseli ne c haracteristics will be s u m marize d b y I O L m o d el ( T F N T 3 0 vs 
T F N T 4 0/ T F N T 5 0/ T F N T 6 0) a n d all m o dels c o m bi ne d usi n g d escri pti ve statistics base d o n 
t he ty pe of vari a ble f or A A S a n d S S. De m o gra p hics i ncl u de a ge, s e x, race a n d nati o nalit y. 
Baseli ne c haracteristics i ncl u de B C D V A, a xial le n gt h, a nteri or c h a m ber d e pt h, kerat o metr y, 
c or neal asti g matis m. 
 
 
 
F or cate g orical varia bl es, n u m ber a n d perce nt a ge of e yes/s u bjects i n eac h cate g or y f or n o n - 
missi n g data will be pres e nte d s uc h as s e x, a ge gr o u p ( < 6 5 years; ≥ 6 5 years), a n d race. F or 
c o nti n u o us varia bles, t he n u m ber of n o n -missi n g e yes/s u bjects, mea n, sta n d ar d de viati o n, 
me dia n, mi ni m u m, a n d ma xi m u m val ues will be prese nte d.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 2  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 2. 4  Effecti ve ness  A n al yses  
T his is a si n gle ar m d escri pti ve st u d y. N o f or mal statistical h y p ot hesis testi n g is pla n ne d f or 
a n y e n d p oi nt, rat her, t he data wil l be s u m marize d usi n g descri pti ve statistics. 
 
Bi n oc ular e n d p oi nts will be s u m marize d at t he s u bject le vel 
 
 
 
1 2. 4. 1  A n al ysis of Ke y Effecti ve ness  E n d p oi nt(s)  
All effecti ve ness e n d p oi nts will be s u m marize d f or eac h visit wit h M o nt h 3 a n d 6 visit res ults 
bei n g t he k e y e n d p oi nt.  
 
•  
Mea n m o n oc ular resi d ual ma nifest c yli n der f or all o perati ve e yes f or all I O L  m o dels 
c o m bi ne d  
•  
Perce nt of I O Ls wit h < 1 0 de gree r otati o n f or all o perati ve e yes (r ot ati o n defi ne d as 
t he differe nce i n I O L a xis of orie ntati o n fr o m p ost o p da y 1)  
•  
Mea n bi n oc ular B C D V A at 4 m i n p h ot o pic li g hti n g  c o n diti o n  
•  
Mea n  bi n oc ul ar  D CI V A  at 6 0c m  i n p h ot o pic  li g hti n g c o n diti o n  
•  
Mea n bi n oc ular D C N V A at 4 0 c m i n p h ot o pic li g hti n g  c o n diti o n  
1 2. 4. 1. 1  St atistic al  H y p ot heses  
N o h y p ot hesis testi n g of t he ke y effecti ve n ess e n d p oi nts is pla n ne d.  
 
1 2. 4. 1. 2  A n al ysis  Met h o ds  
M o n oc ular resi d u al ma nifest c yli n der will be s u m marize d b y visits b y I O L m o del ( T F N T 3 0 
vs T F N T 4 0/ T F N T 5 0/ T F N T 6 0) a n d all m o dels c o m bi ne d f or first e ye a n d sec o n d e ye a n d all 
e yes c o m bi ne d wit h des cri pti ve statistics (t he n u m ber of o bser vati o ns, mea n, me dia n, 
sta n dar d de viati o n, mi ni m u m, ma xi m u m, a n d t w o-si de d 9 5 % CI of t he m ea n). 
 
I O L r otati o n will be s u m mariz e d b y sa m ple siz e, n u m ber, perce nt, a n d c u m ulati ve perce nt f or 
t he f oll o wi n g cate g ori es of a bs ol ute r otati o n: ( < 1 0 a n d < 2 0 de grees) f or all m o dels 
c o m bi ne d.  
 
Bi n oc ular p h ot o pic B C D V A, D CI V A a n d D C N V A will be s u m marize d b y visits wit h 
desc ri pti ve statistics. 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 3  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 4  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 2. 5  H a n dli n g of Missi n g  D at a  
N o missi n g data will be i m p ute d.  
 
1 2. 6  S afet y  A n al yses  
T here are n o safet y h y p ot heses pla n ne d i n t his st u d y. T h e f oc us of t he safet y a nal ysis will be 
a c o m pre he nsi ve d escri pti ve assess me nt of occ urre nce of a d v ers e e v e nts as well as t he ot her 
liste d para meters. D escri pti ve statistics will be pr o vi de d b y all m o del c o m bi ne d f or first a n d 
sec o n d e yes t h at u n der g o atte m pte d i m pla ntati o n. 
 
1 2. 6. 1  A n al ysis of Ke y S afet y  E n d p oi nt(s)  
T he ke y safet y e n d p oi nts are:  
•  
Rate of S SIs (i n cl u di n g rate of S SIs relate d t o o pti cal pr o perties of t he I O L a n d rate of 
all S SIs)  
•  
Rates of se vere a n d m ost b ot hers o me (se p aratel y) vis ual dist ur ba nces re p orte d b y 
Q U VI D q u esti o n naire f or s u bjects wit h bi n oc ular i m pla ntati o n b y  visit  
•  
Rates of a d verse  eve nts  
1 2. 6. 1. 1  St atistic al  H y p ot heses  
N o h y p ot hesis testi n g of t he ke y safet y e n d p oi nts is pla n ne d.  
 
1 2. 6. 1. 2  A n al ysis  Met h o ds  
Rate of S SIs f or eit her e ye will be s u m marize d b y o perati ve e ye.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 5  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
Descri pti ve s u m maries (c o u nts a n d perce nta ges) f or rates of s e vere a n d m ost b ot hers o me 
(se paratel y) vis ual dist ur ba nces as re p ort e d b y t he s u bjects usi n g t he Q U VI D q uesti o n naire 
will be prese nte d. T h ese rates are acc o m pa nie d b y t w o -si de d 9 5 % CIs. 
 
All A Es will be c o de d usi n g t he Me dical Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A). 
Oc ular A Es will be s u m mariz e d b y o perati ve e ye. Descri pti ve ta bles (c o u nt a n d perce nta ge) 
a n d listi n g will be ge nerate d f or A Es bas e d u p o n t he cate g ories of oc ul ar a n d m o n oc ular A Es, 
seri o us a n d n o n-seri o us A Es, as a p pr o priate. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 6  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 2. 8  S a m ple Size  J ustific ati o n  
T he c h oice of sa m ple siz e is n ot base d o n statistical c o nsi derati o ns.  
 
A p pr o xi matel y 5 6 s u bj ects will be bilaterall y i m pla nte d t o o btai n data f or at least 5 0 s u bjects 
( 1 0 0 e yes) at M o nt h 6, ass u mi n g a dr o p o ut r ate of 1 0 % o ver a 6 m o nt h peri o d. T he precisi o n 
esti mates bel o w are pres e nte d f or i n di vi d ual e ye s u m maries. All e ye s u m maries will ha ve 
i ncreas e d precisi o n. 
 
F or vis ual a c uit y, wit h a sa m ple siz e of 5 0 e yes a n d ass u mi n g a sta n d ar d de viati o n of  
0. 1 8 l o g M A R 
 a t w o-si de d 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 7  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
9 5 % c o nfi de n ce i nter val base d o n lar ge sa m ple z statistics will e xte n d 0. 0 5 l o g M A R fr o m t he 
o bser ve d me a n.  
 
F or resi d ual c yli n der, a t w o -si de d 9 5 % c o nfi dence i nter val bas e d o n lar ge sa m ple z statistics 
will e xte n d 0. 1 1 D fr o m t he o bser ve d m ea n, ass u mi n g a sta n d ar d de vi ati o n of 0. 4 0 D  
 
 
 
F or a n y e ve nt w h ere a zer o i nci de nce is o bser ve d i n 5 0 e yes i m pla nte d  wit h st u d y I O L, t h e 
u p per e x act bi n o mial 9 5 % c o nfi de n ce li mit is less t ha n 6 %. T h us, wit h 9 5 % c o nfi de n ce, t he 
tr ue a d verse e v e nt rate is less t ha n 6 %. 
 
1 3  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 3. 1  S u bject  C o nfi de nti alit y  
T he I n vesti gat or m ust e ns ure t hat t he s u bject’s a n o n y mit y is mai ntai ne d t hr o u g h o ut t he 
c o urse of t he st u d y. I n partic ular, t he I n v esti gat or m ust kee p a n e nr oll me nt l o g wit h 
c o nfi de ntial i de ntif yi n g i nf or mati o n t hat c orres p o n ds t o t he s u bject n u m bers a n d i n itials of 
eac h st u d y partici pa nt. At t he e n d of t he cli nical st u d y, t he St u d y S p o ns or will c ollect a c o p y 
of t he e nr oll me nt l o g wit h o ut a ny i de ntifyi n g s u bject i nf or m ati o n . All d oc u me nts s u b mitte d 
t o t he St u d y S p o ns or will i de ntif y t he s u bjects e x cl usi vel y b y n u m ber a n d d e m o gra p hic 
i nf or mati o n. N o ot her pers o nall y i de ntif yi n g i nf or mati o n will be tra ns mitte d t o t he St u d y 
S p o ns or.  
 
T he St u d y S p o ns or ma y release a n o n y mize d st u d y data t o e xter nal researc h ers f or p ur p oses 
of f ut ure researc h dir ectl y relate d t o t he st u d y o bj ecti ves, or f ut ur e res earc h t hat is be y o n d t he 
sc o pe of t he c urre nt st u d y o bje cti ves. T he I nf or m e d C o nse nt F or m e x plai ns t his t o st u d y 
s u bjects. A n o n y mizati o n mea ns t hat all i de ntifia ble i nf or mati o n will be re m o ve d fr o m t he 
dataset a n d all li n k s t o t he s u bjects i n t he st u d y will be re m o ve d. A n o n y mizati o n of t he data 
will mai ntai n c o nfi de ntialit y of t he s u bjects w h o p artici pate i n t he st u d y s o t hat t he y ca n n ot 
be i de ntifie d b y e xter nal researc hers. T he a n o n y mize d data set will c o ntai n rec or ds fr o m all 
of t he s u bjects i n t he c urre nt st u d y, b ut t he a n o n y mizati o n pr ocess mi g ht c ha n ge t he dat a set 
i n s o me wa ys, s o e xter nal researc hers will be i nf or me d t hat t he y mi g ht n ot be a ble t o 
d u plicate s o me of t he res ults fr o m t his  st u d y. 
 
1 3. 2  C o m pleti o n of S o urce D oc u me nts a n d C ase Re p ort  F or ms  
T he nat ure a n d l ocati o n of all s o urce d o c u me nts will be i de ntifie d t o e ns ure t hat ori gi nal dat a 
re q uire d t o c o m plet e t he C R Fs e xist a n d are accessi ble f or verificati o n b y t he site m o nit or, 

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 8  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
a n d all discre p a ncies  s hall be a p pr o priat el y d o c u m e nte d via t he q uer y res ol uti o n pr ocess. Site 
m o nit ors are a p p oi nte d b y t he St u d y S p o ns or a n d are i n de pe n de nt of st u d y site staff.  
 
If ele ctr o nic rec or ds are mai ntai ne d, t he met h o d of verificati o n m ust be deter mi ne d i n 
a d va nce o f starti n g t he st u d y. 
 
At a mi ni m u m, s o urce d oc u me nts i ncl u de t he f oll o wi n g i nf or m ati o n f or eac h s u bject:  
 
•  
S u bject i de ntificati o n ( na me, se x,  race/ nati o nalit y) 
•  
D oc u me ntati o n of s u bject eli gi bilit y  
•  
Date of i nf or m e d  c o ns e nt  
•  
Dates of  visits  
•  
D oc u me ntati o n t hat  pr ot oc ol s pecific pr oce d ures were p erf or me d  
•  
Res ults of st u d y para met ers, as re q uire d b y t he  pr ot oc ol  
•  
I P acc o u nta bilit y rec or ds 
•  
D oc u me ntati o n  of  A Es  a n d ot her  safet y para meters  (if a p plica ble)  
•  
Rec or ds re gar di n g me dical hist ories a n d t he use of c o nc o mita nt t hera pies pri or t o a n d 
d uri n g t he  st u d y 
•  
Date of st u d y c o m pleti o n a n d reas o n f or earl y disc o nti n uati o n, if  a p plica ble  
It is re q uire d t hat t he a ut h or of a n e ntr y i n t he s o urce d oc u m e nts be i de ntifi a ble. Direct access 
t o s o urce d oc u me nt ati o n ( me dical r ec or ds) m ust b e all o we d f or t he p ur p ose of verif yi n g t hat 
t he data rec or de d o n t he C R F are c o nsiste nt wit h t he ori gi n al s o urce d ata. 
 
O nl y desi g n ate d i n di vi d uals at t he site will c o m plete t he C R Fs. T he C R Fs m ust be c o m plete d 
at re g ular i nter vals f oll o wi n g t he cli nical st u d y visit sc he d ule. It is e x pecte d t hat all data 
re p orte d h a ve c orres p o n di n g e ntries i n t he s o urce d oc u me nts. T he Pri nci pal I n vesti gat or is 
res p o nsi ble f or re vie wi n g a n d certif yi n g t hat t he C R Fs are acc urate a n d c o m plete. T he o nl y 
s u bject i de ntifiers rec or de d o n t he C R Fs will be s u bject n u m ber, a n d s u bject de m o gra p hic 
i nf or mati o n. 
 
1 3. 3  D at a Re vie w a n d  Cl arific ati o ns  
A re vie w of C R F data t o t he s u bject’s s o urce data will be c o m plete d b y t he site m o nit or t o 
e ns ure c o m plet e ness a n d acc urac y. After t he C R Fs  ha ve bee n c o m plete d, a d diti o nal data 
clarificati o ns a n d/ or a d diti o ns ma y be nee de d as a res ult of t he data clea ni n g pr ocess. D ata 
clarificati o ns are d oc u m e nte d a n d are part of eac h s u bject’s C R F.  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 5 9  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
1 3. 4  S p o ns or a n d M o nit ori n g  Res p o nsi bilities  
T he S t u d y S p o ns or will desi g nat e a m o nit or t o c o n d uct t he a p pr o pri ate site visits at t he 
a p pr o priate i nter vals a cc or di n g t o t he st u d y m o nit ori n g pla n. T h e cli nical i n vesti gati o n will 
be m o nit ore d t o e ns ure t h at t he ri g hts a n d well -bei n g of t he s u bj ects are pr ot ecte d, t he 
re p orte d d ata are acc urate, c o m plete, a n d v erifia bl e fr o m t he s o urce d oc u m e nts, a n d t he st u d y 
is c o n d ucte d i n c o m plia n ce wit h t he c urre nt a p pr o ve d pr ot oc ol (a n d a me n d me nts[s], if 
a p plica ble), wit h c urre nt G C P, a n d wit h a p plica ble re g ulat or y re q uire me nts. 
 
T he site ma y n ot scree n s u bjects or perf or m t he i nf or me d c o nse nt pr o cess o n a n y s u bj ect 
u ntil it recei ves a n otificati o n fr o m a n a p pr o pri ate St u d y S p o ns or re prese ntati ve t hat t he site 
ma y c o m me nce c o n d ucti n g st u d y acti vities. M o nit ori n g will be c o n d u cte d peri o dicall y w hile 
t he cli nical st u d y is o n g oi n g. M o nit ori n g m et h o ds ma y i ncl u d e site visits, tele p h o ne, writte n 
a n d fa x c orres p o n d e nce. Cl ose -o ut visits will ta ke place after t he last visit of t he last s u bject 
at t he site. 
 
A C o or di nati n g I n v est i gat or ma y b e i de ntifie d b y t he St u d y S p o ns or t o re vi e w a n d e n d orse 
t he fi nal st u d y re p ort. I n cases w h ere a C o or di nati n g I n v esti gat or is e n ga ge d, t he St u d y 
S p o ns or will select t he C o or di nati n g I n v esti gat or base d u p o n t heir e x perie nce, q ualificati o ns, 
active st u d y p artici pati o n, a n d t heir willi n g ness a n d a vaila bilit y t o ta ke o n t his r ole.  
 
1 3. 5  Re g ul at or y D oc u me nt ati o n a n d Rec or ds  Rete nti o n  
T he I n vesti gat or is re q uir e d t o mai ntai n u p -t o-date, c o m plete re g ul at or y d oc u me ntati o n as 
i n dicate d b y t h e St u d y S p o ns or a nd t he I n vesti gat or’s files will be re vie we d as part of t he 
o n g oi n g st u d y m o nit ori n g. Fi na ncial i nf or mati o n is t o be ke pt se paratel y.  
 
A d diti o nall y, t he I n vesti gat or m ust kee p st u d y rec or ds a n d s o urce d oc u m e nts c o nsiste nt wit h 
t he ter ms of t he cli nical st u d y a gree me nt wit h t he St u d y S p o ns or. If t he I n v esti gat or retires, 
rel ocates, or f or a n y ot her reas o n wit h dra ws fr o m res p o nsi bilit y of kee pi n g t he st u d y rec or ds, 
t he n t he St u d y S p o ns or m ust be n otifie d a n d s uita ble arra n ge m e nts ma de f or rete nti o n of 
st u dy rec or ds a n d s o urce d oc u me nts nee de d t o c o m pl y wit h nati o nal a n d i nter nati o nal 
re g ulati o ns. 
 
1 3. 6  Q u alit y Ass ur a nce a n d Q u alit y  C o ntr ol  
T he St u d y S p o ns or will sec ure a gree me nt fr o m all i n v ol ve d parties t o e ns ure direct access t o 
all st u d y rel ate d sites, s o urce  dat a a n d d oc u m e nts, a n d re p orts f or t he p ur p ose of m o nit ori n g 
a n d a u diti n g b y t he St u d y S p o ns or, a n d i ns pecti o n b y d o mestic a n d f orei g n re g ulat or y 
a ut h orities. Q ualit y c o ntr ol will be a p plie d t o eac h sta ge of data ha n dli n g t o e ns ure t hat all  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 6 0  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 
data are relia ble a n d ha v e bee n pr ocesse d c orrectl y. A gree me nts ma d e b y t h e St u d y S p o ns or 
wit h t he I n v esti gat or/I nstit uti o n a n d a n y ot her p arties i n v ol ve d i n t he cli nical st u d y will be 
pr o vi de d i n writi n g as part of t he pr ot oc ol or as a se parat e a gree me nt . 
 
1 4  E T HI C S  
T his cli nical st u d y m ust be c o n d ucte d i n acc or da n ce wit h t he et hical pri nci ples c o ntai ne d 
wit hi n:  
 
•  
T he Decl arati o n of H elsi n ki, a n d i n c o m plia nce wit h t he I C H E 6 G C P  C o ns oli date d 
G ui deli ne, I S O 1 4 1 5 5: 2 0 1 1, a n d t he a p plica bl e U S F D A 2 1 C F R  Re g ulati o ns.  
•  
S O Ps  of  t he St u d y  S p o ns or  a n d c o ntract  res earc h or ga nizati o ns  partici pati n g  i n t he 
c o n d uct of t he cli nic al st u d y a n d all ot her a p plica ble  re g ulati o ns. 
•  
N otificati o ns a n d ti meli nes f or re p orti n g pr ot oc ol de viati o ns s h o ul d be base d  u p o n 
a p plica ble Et hics C o m mittee  re q uire me nts 
T he I n vesti gat or m ust e ns ure t hat all pers o n nel i n v ol ve d i n t he c o n d uct of t he st u d y are 
q ualifie d t o perf or m t heir assi g ne d res p o nsi bilities t hr o u g h rele va nt e d ucati o n, trai ni n g, a n d 
e x perie nce. T h e I n vesti gat or a n d all cli nical st u d y staff m ust c o n d uct t he cli nical st u d y i n 
c o m plia nce wit h t he pr ot oc ol. De viati o ns fr o m t his pr ot oc ol, re g ulat or y re q uire me nts a n d/ or 
G C P m ust be rec or de d a n d re p orte d t o t he S p o ns or pri or t o data bas e l oc k. If nee d e d, 
c orrecti ve a n d pre ve nti ve acti o n s h o ul d be i de ntifie d, i m ple me nte d, a n d d o c u me nte d wit hi n 
t he st u d y rec or ds. Us e of wai vers t o de viat e fr o m t he cli nical pr ot oc ol is pr o hi bite d. 
 
Bef ore cli nic al st u d y i nitiati o n, t his pr ot oc ol, t he i nf or me d c o ns e nt f or m, a n y ot her writte n 
i nf or mati o n gi ve n t o s u bj ects, a n d a n y a d vertise m e nts pla n ne d f or s u bject r ecr uit me nt m ust 
be a p pr o ve d b y a n I R B/I E C. T he I n vesti gat or m ust pr o vi de d oc u me ntati o n of t he I R B/I E C 
a p pr o val t o t he St u d y S p o ns or. T he a p pr o val m ust be date d a n d m ust i de ntif y t he a p plica ble 
pr ot oc ol, a me n d me nts (if a n y), i nf or me d c o nse nt f or m, asse nt f or m (if a n y), all a p plica ble 
recr uiti n g materials,  writt e n  i nf or mati o n f or s u bject, a n d s u bject c o m pe nsati o n  pr o gra ms.  T he 
I R B/I E C m ust be pr o vi d e d wit h a c o p y of t he a n y peri o dic safet y u p d ates, a n d all ot her 
i nf or mati o n as re q uir e d b y l oc al re g ulati o n a n d/ or t he I R B/I E C. At t he e n d of t he st u d y, t he 
I n v esti gat or m ust n otif y t he I R B/I E C a b o ut t he st u d y’s c o m pleti o n. T he I R B/I E C als o m ust 
be n otifie d if t he st u d y is ter mi nate d pre mat ure l y. Fi nall y, t he I n vesti gat or m ust re p ort t o t he 
I R B/I E C o n t he pr o gress of t he st u d y at i nter vals sti p ulate d b y t he I R B/I E C. 
 
V ol u ntar y i nf or me d c o ns e nt m ust be o btai ne d i n writi n g fr o m e ver y s u bject a n d t he pr ocess 
s hall be d oc u me nte d bef ore a n y pr oce d ure s pecific t o t he cli nical i n v esti gati o n is a p plie d t o 
t he s u bject. T he I n v esti gat or m ust ha ve a d efi ne d pr ocess f or o btai ni n g c o nse nt. S pecificall y,  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 6 1  of 6 2  
Pri nte d B y:  
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t he I n v esti gat or, or t heir dele gate, m ust e x plai n t he cli nical st u d y t o eac h p ote ntial s u bject a n d 
t he s u bject m ust i n dicate v ol u ntar y c o nse nt b y si g ni n g a n d d ati n g t he a p pr o ve d i nf or me d 
c o nse nt f or m. T he s u bject m ust be pr o vi de d a n o p p ort u nit y t o as k q uesti o ns of t he 
I n v esti gat or, a n d if re q uir e d b y l o cal re g ul ati o n, ot her q ualifie d p erso n nel. T he I n vesti gat or 
m ust pr o vi de t he s u bject wit h a c o p y of t he c o ns e nt f or m writte n i n a la n g ua ge t he s u bject 
u n dersta n ds. T he c o nse nt d oc u me nt m ust meet all a p plica ble l ocal la ws a n d pr o vi de s u bjects 
wit h i nf or mati o n re gar di n g t he p ur p ose, pr oce d ures , re q uire m e nts, a n d restricti o ns of t he 
st u d y, al o n g wit h a n y k n o w n ris ks a n d p ote ntial be nefits ass ociat e d wit h t he I P a n d t he st u d y, 
t he a vaila ble c o m p e nsati o n, a n d t he esta blis he d pr o visi o ns f or mai ntai ni n g c o nfi de ntialit y of 
pers o nal, pr otecte d healt h i nf or mati o n. S u bjects will be t ol d a b o ut t he v ol u ntar y n at ure of 
partici pati o n i n t he st u d y a n d m ust be pr o vi de d wit h c o ntact i nf or mati o n f or t he a p pr o priat e 
i n di vi d uals s h o ul d q uesti o ns or c o ncer ns arise d uri n g t he st u d y. T he s u bject als o m ust be t ol d 
t hat t heir rec or ds ma y be accesse d b y a p pr o priate a ut h orities a n d S p o ns or-desi g nat e d 
pers o n nel. T he I n vesti gat or m ust kee p t he ori gi nal, si g ne d c o p y of t he c o ns e nt (file i n 
s u bject’s me dical r ec or ds) a n d m ust pr o vi de a d u plicate c o p y t o eac h s u bject acc or di n g  t o 
l ocal re g ulati o ns. 
 
T he St u d y S p o ns or ass ur es t hat t he ke y desi g n el e me nts of t his pr ot oc ol will be re gistere d o n 
w w w.cli nicaltrials. g o v  as re q uire d b y c urre nt re g ul ati o ns a n d, if a p plica ble, ot her p u bl ic 
data bases as re q uir e d b y l ocal c o u ntr y re g ulati o ns. I n a d diti o n, res ults of t his st u d y will be 
ma de p u blicl y a vaila ble o n w w w.cli nicaltrials. g o v  re gar dl ess of o utc o me as re q uire d b y 
c urre nt r e g ulati o ns a n d, if a p plica ble, i n ot her p u blic data bases as re q uir e d b y l ocal c o u ntr y 
re g ulati o ns 
 
1 5  R E F E R E N C E S  
1 5. 1  Refere nces a p plic a ble f or all cli nic al  st u dies 
•  
I S O 1 4 1 5 5: 2 0 1 1 Cli nical i n vesti gati o n of me dical de vices f or h u m a n s u bjects - G o o d 
cli nical  practice  

Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
P a ge 6 2  of 6 2  
Pri nte d B y:  
Pri nt Date:  
 
 

Pri nte d B y:  
Pri nt Date:  
Alc o n - B usi ness Use O nl y 
D oc u me nt: T D O C - 0 0 5 7 1 9 9  
St at us: E f f e c t i v e  
Effecti ve D ate: 3 0 -J ul-2 0 2 0  
P r o t o c o l  -  C l i n i c a l  
Versi o n: 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  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Si g nat ure Pa ge f or V- C L N- 0 0 0 1 8 3 3 v 1. 0