| CTRI Number |
CTRI/2024/03/064570 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Two different toric IOLs from 2 different companies will be implanted and their final visual outcomes will be compared. |
|
Scientific Title of Study
|
A prospective, comparative, randomized post-marketing clinical study
to evaluate the safety, efficacy and refractive outcome of two different toric Intraocular Lens
implanted into patients with cataract and corneal astigmatism. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BTVCPL-TOIOL-2023-01 Version 1.0 and Dated 02/11/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Samar Kumar Basak |
| Designation |
Director |
| Affiliation |
Disha eye Hospitals |
| Address |
Disha eye Hospitals 88 63 A Ghospara Road
Barrackpore, Kolkata 700120
West Bengal India
Kolkata
WEST BENGAL
700120
India |
| Phone |
03366360000 |
| Fax |
|
| Email |
basak_sk@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samar Kumar Basak |
| Designation |
Director |
| Affiliation |
Disha eye Hospitals |
| Address |
Disha eye Hospitals 88 63 A Ghospara Road
Barrackpore, Kolkata 700120
West Bengal India
WEST BENGAL
700120
India |
| Phone |
03366360000 |
| Fax |
|
| Email |
basak_sk@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samar Kumar Basak |
| Designation |
Director |
| Affiliation |
Disha eye Hospitals |
| Address |
Disha eye Hospitals 88 63 A Ghospara Road
Barrackpore, Kolkata 700120
West Bengal India
WEST BENGAL
700120
India |
| Phone |
03366360000 |
| Fax |
|
| Email |
basak_sk@hotmail.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 - 380 058 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 - 380 058 Gujarat India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samar kumar basak |
Disha eye Hospitals |
Clinical research department, room number 312 & 308, 3rd floor.
Kolkata
WEST BENGAL |
03366360000
basak_sk@hotmail.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 |
9426125947
divyajyoti.icare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Disha eye hospitals pvt ltd ethics committee |
Approved |
| Institutional Ethics Committee, Divyajyoti Trust - Tejas Eye Hospital |
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 |
| Comparator Agent |
AcrySof IQ Toric IOL (Alcon) |
Total duration of study is 24 months. frequency of study is as below Patients will be followed-up for following schedule:  Visit 0-Pre-operative Visit/Screening Visit  Visit 00- Baseline Visit/Surgery Visit  Visit 1- Post-operative Day 1-2  Visit 2- Post-operative Day 7-14  Visit 3- Post-operative Day 30-60  Visit 4- Post-operative Day 120 to 180  Visit 5-Post-operative Day 330 to 420. AcrySof IQ Toric Lenses are designed to be positioned in capsular bag, replacing the natural crystalline lens |
| Intervention |
EYECRYL TORIC
IOL(BIOTECH VISION CARE
PVT.LTD) |
Total duration of study is 24 months. frequency of study is as below
Patients will be followed-up for following schedule:
 Visit 0-Pre-operative Visit/Screening Visit
 Visit 00- Baseline Visit/Surgery Visit
 Visit 1- Post-operative Day 1-2
 Visit 2- Post-operative Day 7-14
 Visit 3- Post-operative Day 30-60
 Visit 4- Post-operative Day 120 to 180
 Visit 5-Post-operative Day 330 to 420
Eyecryl toric IOLs are designed to be positioned in capsular bag, replacing the natural crystalline lens. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral and Bilateral Implantation
BCVA to be 0.2 Log Mar or Lower
Power withing the range of Investigational IOL
Stability of the cornea
Patients who have and will attend all follow-up appointments
Patients must sign and be given a copy of the written Informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Preoperative ocular pathology
2. Ocular co-morbidities affecting visual outcome
3. Previous intra ocular or corneal surgery
4. Traumatic cataract
5. Corneal Opacities
6. Irregular astigmatism
7. instability of keratometry or biometry measurements;
8. Ophthalmic diseases such as Pseudoexfoliation, glaucoma,
traumatic cataract corneal scars and other co-morbidity that
could affect capsule bag stability |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Rotational Stability,
2. Corrected and Uncorrected Visual Acuity
3. Refraction and Refractive Astigmatism
4. Spherical Equivalence
5. Introcular pressure
6. Change in Endothelial Cell count |
 Visit 1- Post-operative Day 1-2
 Visit 2- Post-operative Day 7-14
 Visit 3- Post-operative Day 30-60
 Visit 4- Post-operative Day 120 to 180
 Visit 5-Post-operative Day 330 to 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Surgery due to early onset of PCO |
3, 6 & 12 Months post surgery |
|
|
Target Sample Size
|
Total Sample Size="276"
Sample Size from India="276"
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)
|
01/04/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
Primary Objectives: To compare and evaluate two different Toric intraocular lenses for spherical and astigmatic correction, and rotational stability in cataract surgery. Secondary Objectives: To assess and compare the safety of two different Toric intraocular lenses.
Below changes in protocol version 1.o to 1.1
|
Change
Summary
|
|
Sr No.
|
Previous
Version
|
Description
|
Current
Version
|
Description
|
|
1.
|
1.0
|
Keratometry Value not added in Visit 2, 3, 4 and 5
|
1.1
|
Added Keratometry value in visit 2 , 3, 4 and 5
|
|
2.
|
Astigmatism Not added in Visit 5
|
Astigmatism added in visit 5
|
|
3.
|
Pupil size not mentioned in visit 2
|
Pupil size added in visit 2.
|
|