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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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
 
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