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CTRI Number  CTRI/2018/02/011832 [Registered on: 09/02/2018] Trial Registered Retrospectively
Last Modified On: 07/02/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of two types of lenses used for eye surgery 
Scientific Title of Study   Comparison of post cataract surgery visual outcomes in patients bilaterally implanted with Eyecryl ACTV Diffractive Multifocal IOL & AcrySof® IQ ReSTOR® Multifocal IOL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S S Haldipurkar 
Designation  Medical Director 
Affiliation  Laxmi Eye Institute and Charitable Trust 
Address  Laxmi Eye Institute and Charitable Trust

Raigarh
MAHARASHTRA
410206
India 
Phone  91-22-27452228  
Fax    
Email  info@laxmieye.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Shetty 
Designation  Consultant Opthalmologist 
Affiliation  Laxmi Eye Institute and Charitable Trus 
Address  Laxmi Eye Institute and Charitable Trust

Raigarh
MAHARASHTRA
410206
India 
Phone    
Fax    
Email  research@laxmieye.org  
 
Details of Contact Person
Public Query  
Name  Dr Vijay Shetty 
Designation  Consultant Opthalmologist 
Affiliation  Laxmi Eye Institute and Charitable Trus 
Address  Laxmi Eye Institute and Charitable Trust


MAHARASHTRA
410206
India 
Phone    
Fax    
Email  research@laxmieye.org  
 
Source of Monetary or Material Support  
Biotech Vision Care Pvt Ltd Block 1, Abhishree Corporate Park, Opp, Swagat Bunglow BRTS Bus Stop, Bopal-Aambli Road, Ahmedabad – 380 058, Gujarat, India Tel: 91 (0)79 66823000 email: indiasales@biotechhealthcare.com 
 
Primary Sponsor  
Name  Biotech Vision Care Pvt Ltd 
Address  Block 1 Abhishree Corporate Park Opp. Swagat Bunglow BRTS Stop Bopal Ambli Road Ahmedabad 380 058 Gujarat 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR S S HALDIPURKAR  Laxmi Eye Institute and Charitable Trust  Cataract Division, Room No G5, Laxmi Eye Institute and Charitable Trust, Uran Road, Panvel
Raigarh
MAHARASHTRA 		 91-22-27452228

info@laxmieye.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Laxmi Eye Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AcrySof® IQ ReSTOR®   Multifocal IOL by Alcon A Novartis Divison Novartis AG 
Intervention  Eyecryl ACTV Diffractive Multifocal IOL  Multifocal lens by Biotech Vision Care Pvt Ltd., India 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients who has been implanted bilaterally with any one of the Multifocal IOL: Eyecryl ACTV Diffractive Multifocal IOL OR AcrySof® IQ ReSTOR® multifocal IOL will be included in the study.
Age 18 and older
Regular corneal topography and corneal astigmatism
Preoperative & postoperative corneal astigmatism of ≤ 0.75D
Clear intraocular media
Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Written informed consent for participation in the study and data protection 
 
ExclusionCriteria 
Details  Patients with best corrected vision less than 6/9 and or N/6
Pupil Size: > 5 mm scotopic size
Previous ocular surgery.
Any active ocular disease (Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism)
Any ocular pathology (corneal, retinal)
Subject who are professional Pilots/truck/Car Drivers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Compare Visual acuity (Distance, Near and Intermediate vision),
Contrast sensitivity(Low and High) 		 Pre Operative
1 month
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
High Order aberrations
Reading Speed
Defocus Curve
Steriopsis for depth of vsion
Adverse Event/complication after implanting Study IOLs
Improvement in Quality of Life
Photic phenomena by dysphotopsia questionnaire 		 Pre Operative
1 month
3 months
6 months 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/07/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This prospective study aims at assessing and comparing the visual outcomes in patients undergoing restore (AcrySof® IQ ReSTOR®) and biotech (Eyecryl ACTV Diffractive) multifocal IOL implantation after uneventful cataract surgery. Patients undergoing bilateral cataract surgery from the period of May 2017 to April2018 will be included in the study. A period up of   six monthswill be considered for analysis of data. Certain parameters will be evaluated to determine the outcome such as visual acuity, contrast sensitivity, higher order aberrations, patient’s visual satisfaction (with the help of VFQ-33 questionnaire) post cataract surgery.

 

 
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