CTRI/2025/03/081922 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On:
23/07/2026
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)
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 Gaurav Gupta
Eye Sure Super Speciality Eye Hospital
Clinical Research Department, Ground floor, Bhatti Road, Opposite Petrol Pump, Sarabha Nagar, Chandsar Basti, Bathinda, Punjab 151001, India Bathinda PUNJAB
8287588388
drgauravg6@gmail.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 Manish Mahendra
Khairabad Eye Hospital and Mahendra Eye Institute Trust
Room No-1, Department of Ophthalmology, 112/200, Kanpur Vidya Mandir, Khalasi Lane, Swaroop Nagar, Kanpur Kanpur Nagar UTTAR PRADESH
9919335544
drmanishmahendra@gmail.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
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.