| CTRI Number |
CTRI/2025/08/092305 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to check the safety and performance of the EYECRYL PLUS 600 lens in participants undergoing cataract surgery. |
|
Scientific Title of Study
|
A Prospective, single arm, multicentric, clinical study of EYECRYL PLUS (600) intraocular lens to assess performance and safety in patients undergoing cataract surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BVC-OPH-28-0625 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Gajiwala |
| Designation |
MEDICAL DIRECTOR |
| Affiliation |
Tejas eye hospital |
| Address |
Tejas eye hospital, Suthar Falia, Opposite Hanuman Temple, At and Post Mandvi,
District Surat
Surat
GUJARAT
394160
India |
| Phone |
09426125947 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MR Bhargav Joshi |
| Designation |
AGM Clinical Affairs |
| Affiliation |
BIOTECH VISION CARE PVT LTD |
| Address |
Block 1, Abhishree corporate park, opp. swagat bunglow, BRTS Stop, Bopal Ambli road
Ahmadabad
GUJARAT
380058
India |
| Phone |
09925925667 |
| Fax |
|
| Email |
bhargav.joshi@biotechhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
MR BHARGAV JOSHI |
| Designation |
AGM Clinical Affairs |
| Affiliation |
BIOTECH VISION CARE PVT LTD |
| Address |
Block 1, Abhishree corporate park, opp. swagat bunglow, BRTS Stop, Bopal Ambli riad
Ahmadabad
GUJARAT
380058
India |
| Phone |
09925925667 |
| Fax |
|
| Email |
bhargav.joshi@biotechhealthcare.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 - 380058 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Biotech vision care pvt ltd |
| Address |
Block 1, Abhishree corporate park, opp. swagat bunglow, BRTS Stop, Bopal Ambli riad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakhar Singh |
Dr. Shroffs Charity Eye Hospital |
Pvt. Retina Department, First Floor, clinical Research room no. 2
5027, Kedarnath Ln, opposite DAV School,
Daryaganj, Delhi, 110002
Central
DELHI |
91084 63230
drprakharsingh5770@gmail.com |
| Dr Jagdeesh Kumar Reddy |
Sankara eye foundation |
Clinical Research Dept,
Innovation centre, 3rd
Floor, Main buliding,
Sankara Eye Hospital,
16 A, Sathy Road,
Sivanandapuram,
Coimbatore- PIN
641035, Tamil Nadu
Coimbatore
TAMIL NADU |
08838340385
reddyjk@yahoo.com |
| Dr Uday Gajiwala |
Tejas eye hospital |
Office number 4 clinical trial department, Ground floor, Tejas Eye Hospital Run by Divyajyoti Trust Suthar Falia, Opp. Hanuman Temple, At & Po. Mandvi, Dist. : Surat - 394160 GUJARAT
Surat
GUJARAT |
09426125947
divyajyoti.icare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional ethics committee divyajoti trust tejas eye hospital |
Approved |
| Sankara eye hospital instituional ethics committee |
Approved |
| Shroff charitable eye hospital ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EYECRYL PLUS (600) intraocular lens |
Total duration of study is 24 months, visit schedule is Pre-operative Visit/Screening Visit Surgery Visit Post-operative 1 to 2 Days Post-operative 7 Days to 14 Days Post-operative 30 Days to 60 Days Post-operative 120 Days to 180 Days Post-operative 330 Days to 420 Days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patient, 18 years old or older will be enrolled in the study
2 Patient with cataract
3 Calculated IOL power is within the range of the study IOL
4 Patients must sign and be given a copy of the written Informed Consent form
5 Clear intraocular media other than cataract
6 Patient willing to undergo the investigations and comply with the follow-up schedule |
|
| ExclusionCriteria |
| Details |
1 Previous intraocular or corneal surgery
2 Pregnancy or lactation
3 Concurrent participation or participation in the last 30 days in any other clinical trial
4 Irregular astigmatism
5 instability of keratometry or biometry measurements
6 Vulnerable subjects
7 Patients receiving chloroquine treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of subject achieving distance corrected visual acuity of 0.3 logMAR or better at 12 months post operatively. |
12 months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of best-case subjects achieving best corrected distance visual acuity of 0.3 logMAR or better at 12 months post operatively. |
12 months post operatively. |
|
|
Target Sample Size
|
Total Sample Size="375"
Sample Size from India="375"
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)
|
30/09/2025 |
| 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="2"
Months="0"
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
|
A cataract
is a clouding or opacification of the normally clear lens of the eye or its
capsule (surrounding transparent membrane) that obscures the passage of light
through the lens to the retina of the eye. This blinding disease can affect
infants, adults, and older people, but it predominates the latter group. It can
be bilateral and vary in severity. The disease process progresses gradually
without affecting daily activities early on, but with time, especially after
the fourth or fifth decade, the cataract will eventually mature, making the
lens completely opaque to light interfering with routine activities. Treatment
options include correction with refractive glasses only at earlier stages, and
if cataract mature enough to interfere with routine activities, surgery may be
advised, which is very fruitful. EYECRYL PLUS 600 is a Monofocal Hydrophilic Acrylic
Foldable Intraocular Lens. Eyecryl hydrophilic intraocular lenses are acrylic
foldable single piece multi piece posterior chamber IOL. These IOL are
designed to be surgically implanted in the human eye as a replacement for the
natural crystalline lens. |