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CTRI Number  CTRI/2019/04/018671 [Registered on: 18/04/2019] Trial Registered Prospectively
Last Modified On: 16/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TWO DIFFERENT TORIC IOLS FROM 2 DIFFERENT COMPANIES (TECHNIS AND BIOTECH) WILL BE IMPLANTED AND THEIR FINAL VISUAL OUTCOME WILL BE COMPARED 
Scientific Title of Study   A PROSPECTIVE,COMPARATIVE RANDOMISED CLINICAL STUDY TO EVALUATE THE SAFETY,EFFICACY AND REFRACTIVE OUTCOME OF TWO DIFFERENT TORIC IOLS IMPLANTED INTO PATIENTS WITH CATARACT AND CORNEAL ASTIGMATISM 
Trial Acronym  REFRACTIVE COMPARISION OF TWO TORIC IOLS 
Secondary IDs if Any  
Secondary ID  Identifier 
TORIC_IOL_001  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR KEYA BARMAN 
Designation  SENIOR CONSULTANT 
Affiliation  CENTRE FOR SIGHT EYE INSTITUTE 
Address  CENTRE FOR SIGHT EYE INSTITUTE PLOT NO 9 SECTOR NO 9 OPP R D RAJPAL SCHOOL DWARKA NEW DELHI

South West
DELHI
110077
India 
Phone  9686499992  
Fax    
Email  drkeya.c@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KEYA BARMAN 
Designation  SENIOR CONSULTANT 
Affiliation  CENTRE FOR SIGHT EYE INSTITUTE 
Address  CENTRE FOR SIGHT EYE INSTITUTE PLOT NO 9 SECTOR NO 9 OPP R D RAJPAL SCHOOL DWARKA NEW DELHI

South West
DELHI
110077
India 
Phone  9686499992  
Fax    
Email  drkeya.c@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR KEYA BARMAN 
Designation  SENIOR CONSULTANT 
Affiliation  CENTRE FOR SIGHT EYE INSTITUTE 
Address  CENTRE FOR SIGHT EYE INSTITUTE PLOT NO 9 SECTOR NO 9 OPP R D RAJPAL SCHOOL DWARKA NEW DELHI

South West
DELHI
110077
India 
Phone  9686499992  
Fax    
Email  drkeya.c@gmail.com  
 
Source of Monetary or Material Support  
Biotech Vision Care Pvt. Ltd. Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India  
 
Primary Sponsor  
Name  BIOTECH VISION CARE PVT LTD 
Address  BLOCK 1 ABHISHREE CORPORATE PARK OPP SWAGAT BUNGLOW BRTS STOP BOPAL AMBLI ROAD AHMEDABAD 380058 GUJARAT INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR KEYA BARMAN  CENTRE FOR SIGHT EYE INSTITUTE  ROOM NO 101 DEPARTMENT OF CATARACT 1ST FLOOR PLOT 9 SECTOR 9 OPP R D RAJPAL SCHOOL DWARKA 110077
South West
DELHI 		 9686499992

drkeya.c@gmail.com 
DR KIRAN KIRTANI  CENTRE FOR SIGHT EYE INSTITUTE  Plot No 9, Dwarka Sector 9, Dwarka, New Delhi, Delhi 110075
South West
DELHI 		 08920315341

drkiranp2k@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Centre For Sight Institutional Medical Ethics Committee  Approved 
CFS-IMEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ACRYSOF IQ TORIC IOL (ALCON)  EFFICACY AND REFRACTIVE OUTCOME OF IMPLANTED ACRYSOF ALCON TORIC IOL IN PATIENTS WITH CATARACT AND CORNEAL ASTIGMATISM 
Intervention  EYECRYL TORIC IOL(BIOTECH VISION CARE PVT.LTD)  EFFICACY AND REFRACTIVE OUTCOME OF IMPLANTED BIOTECH EYECRYL TORIC IOL IN PATIENTS WITH CATARACT AND CORNEAL ASTIGMATISM 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Unilateral
2 Adult patient
3 Best corrected visual acuity projected to be 0.2 logMAR or lower
4 Calculated IOL power is within the range of the investigational IOL
5 Stability of the cornea has been demonstrated by keratometry
6 Expected dilated pupil size at least large enough to visualize the axis markings
7 Corneal cylindrical error within the range defined in the clinical investigation plan
8 Patient must have preoperative regular corneal astigmatism from 0.5 to 4.50 D as per corneal topography or keratometry
9 Patients who have and will attend all follow-up appointments
10 Patients must sign and be given a copy of the written Informed Consent form
 
 
ExclusionCriteria 
Details  1 Preoperative ocular pathology
2 Presence of irregular corneal astigmatism
3 Ocular co-morbidities affecting visual outcome
4 Previous intra ocular or corneal surgery
5 Traumatic cataract
6 Corneal Opacities
7 Ophthalmic diseases such as pseudoexfoliation, glaucoma, traumatic cataract corneal scars and other co-morbidity that could affect capsule bag stability
8 Pre-existing corneal astigmatism lesser than 0.75 D
9 Pre-existing retinal disease
10 Pregnant & Lactating women
11 Concurrent participation in another drug or device investigation
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Rotational Stability,
2. Corrected and Uncorrected Visual Acuity
3. Refraction and Refractive Astigmatism
4. Spherical Equivalence
5. Introcular pressure
6. Change in Endothelial Cell count
 		 Pre operatively, day 1,day 15,1,3 and 6 Months.
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Surgery due to early onset of PCO  3 & 6 Months post surgery 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   Phase 4 
Date of First Enrollment (India)   01/05/2019 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 The study results are planned to be shared and published in reputed international ophthalmology journals so as to provide guidance to clinical ophthalmologists in their practice. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		   It is a observational prospective comparative  randomised clinical study to evaluate the safety efficacy and refractive outcome of two different TORIC IOLs implanted into patients with cataract and corneal astigmatism.
  
  Total of 140 eyes are to be considered in the study with 70 eyes in each group where  EYECRYL (BIOTECH ) and TECNIS TORIC  implanted into patients .
  
  Patients are recruited according to the inclusion and exclusion criteria mentioned in the study .Enrollment for 9 months and follow up for 6 months 
  
  Outcomes of Rotational stability, Refraction, Spherical Equivalence,Intra Ocular Pressure,Change in Endothelial cell count are summarized and compared using statistics.

 
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