| CTRI Number |
CTRI/2024/09/073824 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Patient Outcomes and Satisfaction with Two Types of Advanced Intraocular Lenses After Cataract Surgery. |
|
Scientific Title of Study
|
A Prospective, Randomized, Comparative, Post-marketing clinical study to assess and
compare the clinical outcomes and patient satisfaction of two Hydrophobic EDOF Toric
intraocular lenses following bilateral implantation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naren shetty |
| Designation |
Consultant |
| Affiliation |
Narayana Nethralaya Banglore |
| Address |
121C Chord Road 1st R Block Rajaji Nagar Bangalore 560 010 India
Bangalore
KARNATAKA
560010
India |
| Phone |
9900900204 |
| Fax |
|
| Email |
narenshetty.27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naren shetty |
| Designation |
Consultant |
| Affiliation |
Narayana Nethralaya Banglore |
| Address |
121C Chord Road 1st R Block Rajaji Nagar Bangalore 560 010 India
Bangalore
KARNATAKA
560010
India |
| Phone |
9900900204 |
| Fax |
|
| Email |
narenshetty.27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Bhargav Joshi |
| Designation |
Assistant General Manager- Clinical Affairs |
| Affiliation |
Biotech vision care pvt ltd |
| Address |
Block 1 Abhishree corporate park, Opp. Swagat Bunglow, Bopal Ambli road
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, Ambli - Bopal Rd, opp. Swagat Bunglow, Ahmedabad, Gujarat 380058 |
|
|
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
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lional Raj |
Dr. Agrwal Eye Hospital |
Department of Clinical research, 5th Floor, No.15, South Bypass Rd, Vannarpettai, Tirunelveli, Tamil Nadu 627003
Tirunelveli
TAMIL NADU |
9894067910
drlionalraj@gmail.com |
| Dr Naren Shetty |
Narayana Nethralaya |
D Block, 1st floor, room number-2, #121/C Chord Road, 1st ‘R’ Block, Rajaji Nagar, Bangalore -560 010 – India.
Bangalore
KARNATAKA |
9900900204
narenshetty.27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. Agarwal eye hospital institute review board |
Approved |
| NARAYANA NETHRALAYA 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 |
Preloaded Hydrophobic EDOF Toric Lens |
Total duration is 12 months
Preloaded Hydrophobic EDOF Toric Lens are single piece posterior chamber IOLs. The overall diameter of the lens is 13 mm and the optic diameter is 6 mm. These IOLs are designed to be surgically implanted in the human eye as a replacement for the natural crystalline lens. These IOLs are made from medical implantable grade hydrophobic material with less than 5 % water content. This IOL material have refractive index of 1.52 at 35°C. Hydrophobic NY incorporates natural yellow chromophore, which absorbs the UV light and filters violet light. |
| Comparator Agent |
TECNIS Eyhanceâ„¢ Toric II IOL |
Total duration is 12 months
The TECNIS Simplicityâ„¢ Delivery System Model DIU contains the TECNIS Eyhanceâ„¢ Toric II IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. All IOL optical designs are associated with a certain amount of depth of focus. For monofocal IOLs, the amount of depth of focus is typically limited. The TECNIS Eyhanceâ„¢ Toric II IOL use an aspheric anterior surface that creates a small continuous increase in central lens power within the 1 mm diameter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms.
2. Best corrected visual acuity to be better than 20/30 after cataract removal and IOL implantation as estimated by potential acuity meter (PAM) or surgeon estimation
3. ≤ 1.0 D of preoperative keratometric astigmatism
4. Clear intraocular media other than cataract.
5. Given written informed consent by subject.
6. Subjects are willing and able to comply with schedule for follow- up visits.
7. Subjects should be 22 years or older.
|
|
| ExclusionCriteria |
| Details |
1. Systemic disease that could increase the operative risk or confound the outcome.
2. Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)).
3. Ocular condition that may predispose for future complications.
4. Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.
5. Pregnant, lactating woman during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes.
6. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity loss to 20/30 or worse.
7. Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens.
8. If preclinical testing or risk analysis indicates potential for substantially increased light scatter over a monofocal lens, then exclude subjects who are expected to require retinal laser treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm). |
 Pre-operative Visit/Screening Visit
 Surgery Visit/Intra-operative Visit
 Day 1 (1 - 2 days post-operative)
 Week 1 (7 - 14 days post-operative)
 Month 1 (30 - 60 days post-operative)
 Month 6 (120 - 180 days post-operative)
 Month 12 (330 - 420 days post-operative)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Uncorrected distance visual acuity (UCDVA) [photopic]
2) Uncorrected intermediate visual acuity (UCIVA) [photopic]
3) Best corrected distance visual acuity (BCDVA) [photopic]
4) Uncorrected Near visual acuity (UCNVA) [photopic]
5) Distance corrected Near visual acuity (DCNVA) [photopic]
6) Distance-corrected intermediate visual acuity (DCIVA) [photopic]
7) Low Contrast (10%) Distance Corrected Intermediate Visual Acuity [photopic]
8) Low Contrast (10%) Best Corrected Intermediate Visual Acuity [photopic]
9) Defocus curves monocular and binocular
10) Manifest refraction
11) Subject questionnaire
12) Subject ocular and visual symptoms (non-directed questions)
13) Rotational stability
14) Spherical equivalent
|
 Pre-operative Visit/Screening Visit
 Surgery Visit/Intra-operative Visit
 Day 1 (1 - 2 days post-operative)
 Week 1 (7 - 14 days post-operative)
 Month 1 (30 - 60 days post-operative)
 Month 6 (120 - 180 days post-operative)
 Month 12 (330 - 420 days post-operative)
|
|
|
Target Sample Size
|
Total Sample Size="248"
Sample Size from India="248"
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)
|
01/11/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Description: EYECRYL-SERT (model no. PLHFD6T), Preloaded HydrophobicEDOFToric Lens are single piece posteriorchamber IOLs. The overall diameter of the lens is 13 mm and the optic diameter is 6 mm. These IOLs are designed to be surgically implanted in the human eye as a replacement for the natural crystalline lens. These IOLs are made from medicalimplantable grade hydrophobic material with less than 5 % water content. This IOL material have refractive index of 1.52 at 35°C. Hydrophobic NY incorporates natural yellow chromophore, which absorbs the UV light and filters violet light. It has <2% transmission at 400 nm and ≤ 10% Cut-off at 405 nm wavelength. The EYECRYL- SERT Hydrophobic Intraocular lenses have a biconvex optical shape and aspheric surface. The posterior surface of the intraocular lenses has a 360° square edge to reducethe chances of PCO. The TECNIS Simplicity™ Delivery System Model DIU contains the TECNIS Eyhance™ Toric II IOL, which is a one-piece, foldable, posterior chamber lens with anoverall diameter of 13.0 mm and an optic diameter of 6.0 mm. All IOL optical designsare associated with a certain amount of depth of focus. For monofocal IOLs, the amount of depth of focus is typically limited. The TECNIS Eyhance™ Toric II IOL use an aspheric anterior surface that creates a small continuous increase in central lens powerwithin the 1 mm diameter
Purpose: To compare the visual performance of both Hydrophobic EDOF Toric Lens To evaluate the patient satisfaction and quality of vision between the two IOLs, using a subjective questionnaire. |