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CTRI Number  CTRI/2025/03/081922 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   clinical study of two phakic implantable lenses to compare outcomes in patients with moderate to high myopia. 
Scientific Title of Study   A prospective, comparative, randomized, post marketing clinical study of two phakic implantable lenses to compare outcomes in patients with moderate to high myopia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BVC-OPH-05-0724  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prabhakar Kolamuri 
Designation  Sr. Director 
Affiliation  Techsol Life Sciences Private Limited, 
Address  CRO Services Division, No:845, Road No: 45, Ayyappa Society, Madhapur, Hyderabad, Telangana

Hyderabad
TELANGANA
500081
India 
Phone  9741766881  
Fax    
Email  prabhakar.kolamuri@techsollifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhargav Joshi 
Designation  Assistant General Manager – Clinical Affairs 
Affiliation  BIOTECH VISION CARE PVT. LTD 
Address  Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop, Bopal - Ambli Road

Ahmadabad
GUJARAT
380 058
India 
Phone  9925925667  
Fax    
Email  bhargav.joshi@biotechhealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhargav Joshi 
Designation  Assistant General Manager – Clinical Affairs 
Affiliation  BIOTECH VISION CARE PVT. LTD 
Address  Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop, Bopal - Ambli Road

Adilabad
GUJARAT
380 058
India 
Phone  9925925667  
Fax    
Email  bhargav.joshi@biotechhealthcare.com  
 
Source of Monetary or Material Support  
Biotech Vision Care Pvt Ltd  
 
Primary Sponsor  
Name  Biotech Vision Care Pvt Ltd  
Address  Abhishree Corporate Park, Block 1, Ambli - Bopal Rd, opp. Swagat Bunglow BRTS stop, Ahmedabad, Gujarat 380058. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vitthal Satav  Aakash Eye Clinic and Laser Center  1st floor, City Space, Pune nagar road, near four point hotel, CLover Park, Viman Nagar, Pune
Pune
MAHARASHTRA 		 9822058760

vitthalsatav@gmail.com 
Dr Jitendra Nenumal Jethani  Aman Hospital and Research Centre  Aman Hospital and Research Centre, Department of Opthalmolgy, Room No: 18,15 Shaswat, Gotri Rd, opposite ESI Hospital, Vadodara, Gujarat 390021
Vadodara
GUJARAT 		 9825560870

xethani@rediffmail.com 
Dr Vijay Kumar Singh  Carrier Institute of Medical Sciences  Carrier Institute of Medical Sciences, Department of Ophthalmology, 5th floor,Ghaillia, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 9793124449

vijaydr06@gmail.com 
Dr Suhana Datta  Clear View Super Speciality Clinic  Department of Opthalmology,1st floor, 349, Shantipally, Rajdanga, Kolkata
Kolkata
WEST BENGAL 		 9836310729

suhanargk@gmail.com 
Dr Virendra Agrawal  Dr. Virendra Laser Phaco Surgery Centre,  Clinical Research Department, Room No: 02, First floor,Tonk Phatak, Tonk Road, Gandhi Nagar, Jaipur,Rajasthan-302015
Jaipur
RAJASTHAN 		 9314017147

virendravlpsc@yahoo.com 
Dr P Seshu Babu  Govt Medical College and Government General Hospital  Department of Ophthalmology, OPD no-16, First floor, Srikakulam-532001,A.P, India
Srikakulam
ANDHRA PRADESH 		 9493905251

drseshubabupggh@yahoo.com 
Dr M Nivean  M.N. Eye Hospital  M.N. Eye Hospital, Clinical Research Department,2nd floor, chennai, Tamil nadu
Chennai
TAMIL NADU 		 9842340407

nivean69@gmail.com 
Dr Anuj Kodnani   Parul Sevashram Hospital  2nd floor, Department of Opthalmology, P.O. Limda, Tal. Waghodia,
Vadodara
GUJARAT 		 9428974800

anuj_kodnani@yahoo.co.in 
Dr Sudheer  Pradeena Eye Hospital  Eluru Rd, Mayor St, beside Sri Chaitanya techno school, Maruthi Nagar, Vijayawada, Andhra Pradesh 520004
Krishna
ANDHRA PRADESH 		 9885100254

drctresearch@gmail.com 
Dr Dharamveer Singh Choudhary  SMS Medical College and attached Hospital  Department, Ophthalmology, Room no: C-48, First floor, Charak Bhavan, JLN Marg, Jaipur, Rajasthan-302004
Jaipur
RAJASTHAN 		 9252032662

dharamveer2@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Independent Ethics Committee-Fusion Clinical Research  Approved 
Institutional Ethics Committee, Govt Medical College and Government General Hospital  Approved 
Institutional Ethics Committee, Aman Hospital  Approved 
Institutional Ethics Committee, Dr. Virendra Laser Phaco Surgery Centre,  Approved 
Institutional Ethics Committee, Medical Care Centre and Hospital, Lucknow  Approved 
Institutional Ethics Committee, SMS Medical College and attached Hospital  Approved 
Lake Town Scientific Research and Clinicians Association  Approved 
Parul University Institutional Ethics Committee for Human Research  Approved 
Rising Medicare Hospital & Institutional Ethics Committee  Approved 
Universal Ethics Committee, MN eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EYECRYL PHAKIC Intraocular Lens  Diopter Range: +10.0 D to -25.0 D (with 0.5D step) 
Comparator Agent  Visian ICL  Diopter Range: -3.0 to -16.0 D (with 0.5D step)  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients 21 years.
2. Calculated IOL Power is within the range of the study IOLs.
3. The ACD from endothelium is between 2.80 mm and 4.50 mm.
4. The white to white (WTW) is either between 9.56 mm and 10.52 mm or between 12.15 mm and 12.92 mm.
5. Subject falling under spherical power range of 0 D to -25.0 D.
6. Subject has monocular UDVA 0.5 LogMAR or worse.
7. Subject has had stable refraction history (within 0.5 D each for spherical power and cylindrical power) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
8. The subject, who is a current contact lens wearer, needs to demonstrate stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates, and stability of the refraction is determined by the following criteria:
a. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
b. Two refractions were performed at least 7 days apart.
9. The subject, who is expected to have the residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the
anticipated correction.
10. Patients willing to attend all follow-up appointments.
11. Patients must sign and be given a copy of the written Informed Consent Form.
12. Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner use effective
contraception during the study.  
 
ExclusionCriteria 
Details  1. Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
2. The subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject.
3. Subject with ocular condition that may predispose the subject to future complications.
4. Subject with previous intraocular or corneal surgery.
5. Subject with less than the minimum endothelial cell density of 2000 cells/mm² at the time of enrollment.
6. Pregnant or planning to become pregnant, or is lactating during
the course of the evaluation.
7. Other conditions associated with fluctuation of hormones.
8. ACD measured from the endothelium lower than 2.8 mm.
9. Concurrent participation in another drug or device evaluation.
10. Cataract of any grade.
11. Coefficient of variation of endothelial cell area greater than 0.45.
12. Percent Hexagonality of endothelial cell shape less than or equal to 45%.
13. Monocular subject.
14. Vulnerable subjects as defined in section 11.3.10.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy and the residual refractive error of EYECRYL
TM Phakic IOL versus Visian ICL TM in moderate to high myopia patients 		 1, 3, 6 & 12 months Post-operative 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the safety of EYECRYL TM Phakic IOL versus Visian ICL TM in moderate to high myopia patients.   1, 3, 6 & 12 months Post-operative 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   17/03/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
The objective of the post-marketing clinical study is to compare the performance and safety outcomes of EYECRYL Phakic IOL (Biotech Vision Care), with Visian ICL (STAAR Surgical) in patients with moderate to high myopia. Treating moderate to high myopia treatment poses challenges, as traditional glasses and contact lenses often fall short, and laser vision correction may not be safe for severe cases. Phakic IOLs, which are placed inside the eye without removing the natural lens, offer an alternative that preserves corneal structure, making them suitable for patients with moderate to high myopia who cannot undergo corneal refractive surgery. This study assesses the long-term safety and effectiveness of EYECRYL, Phakic IOL and Visian ICL TM  (STAAR Surgical), focusing on complications (e.g., cataract risk, endothelial cell loss) and visual outcomes like acuity, stability, and quality, especially for high myopia. By comparing these lenses, the study aims to identify which design aspects (e.g., anterior vs.posterior chamber placement) yield better patient outcomes, informing best practices.
Additionally, the research supports personalized treatment approaches, allowing clinicians to select implants based on patient-specific factors, such as corneal thickness and eye health. These findings could enhance confidence in post-marketing surveillance and offer transparent evidence for both clinicians and regulatory bodies on the real-world performance of PILs.
 
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