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CTRI Number  CTRI/2018/11/016467 [Registered on: 28/11/2018] Trial Registered Prospectively
Last Modified On: 09/10/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Post Marketing Surveillance study 
Study Design  Single Arm Study 
Public Title of Study   PanOptix post marketing data in Indian population  
Scientific Title of Study   An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population 
Trial Acronym  ILD432-P001 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhay Vasavada 
Designation  M.S., F.R.C.S. 
Affiliation  Raghudeep Eye Hospital  
Address  Raghudeep Eye Hospital, Gurukul Road,Memnagar,

Ahmadabad
GUJARAT
380052
India 
Phone  917940400909  
Fax    
Email  icirc@abhayvasavada.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shovan Bhattacharrya  
Designation  Senior Manager- Medical Affairs  
Affiliation  Alcon Laboratories Ind Pvt Ltd 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield,

Bangalore
KARNATAKA
560048
India 
Phone  08040064604  
Fax    
Email  shovan.bhattacharrya@alcon.com  
 
Details of Contact Person
Public Query  
Name  Dr Arindam Dey 
Designation  Country Head, Medical Affairs  
Affiliation  Alcon Laboratories Ind Pvt Ltd 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield,

Bangalore
KARNATAKA
560048
India 
Phone  08040064683  
Fax    
Email  arindam.dey@alcon.com  
 
Source of Monetary or Material Support  
Alcon Laboratories India Pvt Ltd 
 
Primary Sponsor  
Name  Alcon Laboratories India Pvt Ltd 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield, Bangalore, Karnataka 560048, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jagadesh Reddy   L V Prasad Eye Institute   GPR Building, Clinical Research Department, Room No;123, Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No: 2,
Hyderabad
TELANGANA 		 04030612124

jagadeshreddy@lvpei.org 
Dr Abhay Vasavada  Raghudeep Eye Hospital   Catarat Department, Ground Floor, Room No: 101, Gurukul Road, Memnagar,
Ahmadabad
GUJARAT 		 917940400909

icirc@abhayvasavada.com 
Dr RR Sudhir   Sankara Nethralaya  AS Block, Cornea Department, 2nd floor, Room no: 6210, (A Unit of medical Research Foundation), 41/18, College Road, Nungambakkam
Chennai
TAMIL NADU 		 09444174847

drrrs@snmail.org 
Dr D Ramamurthy   The Eye Foundation   Out Patient Department consulting, Room no: 01, Ground Floor, 582, Diwan Bahadur Rd, R.S. Puram
Coimbatore
TAMIL NADU 		 09443317791

drramamurthy@theeyefoundation.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics committee  Approved 
Ethics Committee- LV Prasad Eye Institute  Approved 
Ethics Committee- Sankara Nethralaya  Approved 
Institutional Ethics Committee of Narayala Nethralaya  Approved 
The Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H258||Other age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Able to comprehend and willing to sign informed consent and complete all
required postoperative follow-up procedures;
2. Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens;
3. Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes.

Other protocol-specified inclusion criteria may apply. 
 
ExclusionCriteria 
Details  1. Pregnant or lactating, current or planned, during the course of the study;
2. Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision);
3. Clinically significant corneal abnormalities;
4.History of retinal conditions;
5.Previous refractive surgery, including LASIK;
6.Glaucoma;
7.Any condition that may not be appropriate to this study, as per the Investigator’s expert medical opinion.

Other protocol-specified exclusion criteria may apply. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Best corrected binocular visual acuity at distance (4 m) post bilateral implantation  At 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Subjects will be assessed for monocular visual acuity at 1 month after each
implantation and monocular as well as binocular visual acuity 3 months post bilateral (second eye) implantation via various assessments
2. Binocular defocus curve at 3 months post bilateral implantation (post second eye surgery)
3. Subjective symptoms questionnaire at baseline and 3 months post bilateral
implantation - standard questionnaire from Alcon 		 1 month & 3 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   05/12/2018 
Date of Study Completion (India) 15/07/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet Published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Brief Summary : The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.

Detailed Description: The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction
and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.
 
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