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CTRI Number  CTRI/2024/12/078539 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Post Marketing Clinical Study to Examine the safety and performance of REPER RPR-13 Hydrophobic Intraocular lens.  
Scientific Title of Study   Prospective single arm, post marketing clinical study of REPER RPR-13 Hydrophobic Intraocular Lens to assess performance and safety in patients undergoing cataract surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RPR-13 Protocol Version 1.0 dated 25/11/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Uday Gajiwala 
Designation  Principal Investigator 
Affiliation  Tejas Eye Hospital 
Address  Tejas Eye Hospital, Divya Jyoti Trust, Mandi, Dist: Surat

Surat
GUJARAT
394160
India 
Phone  02623221180  
Fax    
Email  divyajyoti.icare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Uday Gajiwala 
Designation  Principal Investigator 
Affiliation  Tejas Eye Hospital 
Address  Tejas Eye Hospital, Divya Jyoti Trust, Mandvi, Dist: Surat

Surat
GUJARAT
394160
India 
Phone  02623221180  
Fax    
Email  divyajyoti.icare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Uday Gajiwala 
Designation  Principal Investigator 
Affiliation  Tejas Eye Hospital 
Address  Tejas Eye Hospital, Divya Jyoti Trust, Mandvi, Dist: Surat

Surat
GUJARAT
394160
India 
Phone  02623221180  
Fax    
Email  divyajyoti.icare@gmail.com  
 
Source of Monetary or Material Support  
Rayner Surgical India Pvt Ltd, Formerly, Surgicon Healthcare Pvt Ltd 
 
Primary Sponsor  
Name  Rayner Surgical India Pvt Ltd formerly Surgicon Healthcare Pvt Ltd 
Address  611/612 Sakar V, Ashram Road Ahmedabad 380009 
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 Uday Gajiwala  Tejas Eye Hosptal  R&D Department, Divyajyoti Trust, Suthar Faliya, Mandvi, Dist: Surat
Surat
GUJARAT 		 02623221180

divyajyoti.icare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, DIVYAJYOTI TRUST, TEJAS EYE HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteers undergoing routine cataract surgery with intraocular lens implant 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cataract Surgery  A non-masked randomized controlled clinical trial conducted at a single hospital. patients with age-related cataracts eye were randomly assigned to undergo cataract operative procedure. The main clinical outcomes were safety (complication rates) and efficacy 2 months to one year a subset of 50 trial participants received questionnaires at 14 days, 60 days, 180 days and at 1 year after surgery to measure visual functioning and vision-related quality of life." 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adults, Subjects who have already undergone cataract surgery using IOL, Calculated IOL power is within the range of the investigational IOL (+ 10.0 to 30.0 Diopter), Subjects available after contact and willing to come for follow up during the clinical study, Subjects with signed informed consent, Subject having clear intraocular media other than cataract.
 
 
ExclusionCriteria 
Details  Patients unwilling to participate in the study, subject with previous intraocular or corneal surgery, Subject having traumatic cataract, Pregnancy or lactation, Concurrent participation in another drug or device investigation, Instability of keratometry or biometry measurements, Irregular astigmatism.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the intraoperative safety and performance of the Intraouclar Lens.   2 Months, 6 Months, 12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To determint the prescence of lens related adverse events, residual risks and visual acuity in the individuals on whom the device was implanted  2 months, 6 months, 1 year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   04/01/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Hydrophobic Intraocular lenses are routinely implanted worldwide, REPER RPR-13 are Hydrophobic monofocal intraocular lenses, similar to normal hyrodphobic lenses manufactured, however the manufacturer REPER NN, being located in Russia and due to sanctions in Russia, the manuacturer is unable to obtain a free sale certificate in any GHTF Countries, hence this clinical trial to evaluate the safety and efficary of RPR-13 Intraocular lens,  
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