| CTRI Number |
CTRI/2024/08/071812 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of visual outcomes of a new trifocal intraocular lens for distance, intermediate and near
visual acuity. |
|
Scientific Title of Study
|
A Prospective Comparative randomized post marketing clinical study to assess and compare the visual performance and safety of two different trifocal Intraocular lens 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 Shreyas Ramamurthy |
| Designation |
Consultant |
| Affiliation |
The Eye Foundation |
| Address |
582 A Diwan Bahadur Rd R S Puram Coimbatore
Coimbatore TAMIL NADU 641002 India |
| Phone |
9894231663 |
| Fax |
|
| Email |
shreyas@theeyefoundation.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shreyas Ramamurthy |
| Designation |
Consultant |
| Affiliation |
The Eye Foundation |
| Address |
582 A Diwan Bahadur Rd R S Puram Coimbatore
TAMIL NADU 641002 India |
| Phone |
9894231663 |
| Fax |
|
| Email |
shreyas@theeyefoundation.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Shreyas Ramamurthy |
| Designation |
Consultant |
| Affiliation |
The Eye Foundation |
| Address |
582 A Diwan Bahadur Rd R S Puram Coimbatore
TAMIL NADU 641002 India |
| Phone |
9894231663 |
| Fax |
|
| Email |
shreyas@theeyefoundation.in |
|
|
Source of Monetary or Material Support
|
| Biotech vision care pvt ltd |
|
|
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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreyas Ramamurthy |
The Eye Foundation |
Clinical Research Department, Basement, 582 A Diwan Bahadur Rd R S Puram Coimbatore Tamil Nadu 641002 Coimbatore TAMIL NADU |
9894231663
shreyas@theeyefoundation.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committe of eye foundation |
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 Panoptix |
The AcrySof® IQ PanOptix® Trifocal Intraocular lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients.
Duration of study is 24 months
Below is study frequency
1) Pre-operative Visit/Screening Visit
2)Surgery Visit/Intra-operative Visit
3) Post-operative 1 to 2 Days 4) Post-operative 7 Days to 14 Days
5) Post-operative 30 Days to 60 Days
6) Post-operative 120 Days to 180 Days
7) Post-operative 330 Days to 420 Day
|
| Intervention |
OPTIFLEX TRIO Intraocular Lenses (IOLs) |
OPTIFLEX TRIO Intraocular Lenses (IOLs) are Trifocal hydrophobic aspheric foldable single piece posterior chamber IOLs.
Duration of study is 24 months and below is frequency
1) Pre-operative Visit/Screening Visit
 Surgery Visit/Intra-operative 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 Day |
|
|
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
7. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study
|
|
| ExclusionCriteria |
| Details |
1. Previous intraocular or corneal surgery
2. Traumatic cataract
3. Pregnancy or lactation
4. Concurrent participation in another drug or device investigation
5. Instability of keratometry or biometry measurements
6. Irregular astigmatism
7. More than 1 D of pre-operative corneal astigmatism
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uncorrected Intermediate Visual Acuity (UIVA) (Photopic) |
Measured at Time frame:
Monocular
Post-operative: 120-180 days, 330-420 days
Binocular: Post-operative 330-420 days] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="216" Sample Size from India="216"
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)
|
05/09/2024 |
| 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
|
Presbyopia is one of the most common causes of vision impairment, affecting an estimated 2 billion people, globally.1 Presbyopia has been associated with negative impacts on quality of life in people aged 40 and above from developing and developed nations alike because it causes difficulties with reading and with accomplishing near vision tasks. Non-invasive methods of correcting presbyopia have been used for many years. While bifocal or multifocal progressive addition lenses, monofocal or bifocal contact lenses can provide satisfactory distance and near vision to presbyopes without the potential risks of a surgical procedure, they cannot restore or substitute the true process of accommodation of a younger individual. Among the surgical options, presbyopia correction can be achieved with excimer or femtosecond laser ablation on cornea (LASIK, PRK, Presbylasik, Supracor, Intracor, etc.), Another recent corneal approach is the insertion of inlays, both artificial and made of corneal tissue in order to change the central curvature of the cornea. Lens extraction with implantation of multifocal, monofocal (monovision) or accommodative intraocular lenses is another method for correction of presbyopia, and has started to become the preferred method for presbyopic correction, particularly in a cataract-aged population. Increasingly, trifocal IOLs – offering correction for near, intermediate and distance vision – are more frequently used.
Purpose:
To evaluate and compare the visual performance of two different trifocal intraocular lens in terms of quality of vision and verify the safety profile |