| CTRI Number |
CTRI/2025/08/092306 [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 ASHFY600 lens in participants undergoing cataract surgery |
|
Scientific Title of Study
|
A Prospective, single arm, multicenter, clinical study of EYECRYL PLUS (ASHFY600) intraocular lens to assess the performance and safety in patients undergoing cataract surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BVC-OPH-29-0625 Version 1.0 Dated 24/07/2025 |
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 Run by Divyajyoti Trust Suthar Falia Opp Hanuman Temple
Surat
GUJARAT
394160
India |
| Phone |
09426125947 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
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 |
|
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 Road, Ahmedabad - 380058 Gujarat India |
| 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 Nidhi Gupta |
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 |
98730 08654
nidhiophthal@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
Coimbatore
TAMIL NADU |
8838340385
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 Surat GUJARAT
Surat
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 (ASHFY600) 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 |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 18 year or greater
2 Cataract
3 Calculated IOL power is within the range of the investigational IOL.
4 Given consent to use device related data for scientific purpose
5 Clear intraocular media other than cataract
6 Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose
7 Patient willing to come for all post-operative follow-up |
|
| ExclusionCriteria |
| Details |
1 Previous intraocular or corneal surgery
2 Traumatic cataract
3 Pregnancy or lactation
4 Concurrent participation or participation in the last 30 days in any other clinical trial
5 Irregular astigmatism
6 Instability of keratometry or biometry measurements
7 Vulnerable subject.
8 Patients receiving chloroquine treatment.
9 Patient having Microphthalmia.
10 Patient having Chronic Uveitis |
|
|
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 Month 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 Month 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
|
Cataract surgery with intraocular lens implantation is one of the most commonly performed surgical procedures worldwide. The World Health Organization predicts that an estimated
32 million cataract surgeries will be performed globally
in 2020. 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. Cataracts are a
significant cause of blindness worldwide. 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 ASHFY600 is a Monofocal Hydrophobic natural yellow
Acrylic Foldable Intraocular
Lens. Eyecryl hydrophobic intraocular lenses IOL are acrylic foldable
single piece posterior
chamber IOLs. These IOLs are designed to be surgically implanted in the human eye as a replacement for the natural
crystalline lens |