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CTRI Number  CTRI/2022/01/039218 [Registered on: 06/01/2022] Trial Registered Prospectively
Last Modified On: 09/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
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   Assessment of visual performance of a new trifocal intraocular lens for visual quality and safety (Optiflex TRIO, Biotech Europe Meditech Inc. Ltd.) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namrata Sharma 
Designation  Professor 
Affiliation  Dr. R. P. Centre for Ophthalmic Sciences 
Address  Room no. 481, 4th floor, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  9810856988  
Fax    
Email  namrata.sharma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Namrata Sharma 
Designation  Professor 
Affiliation  Dr. R. P. Centre for Ophthalmic Sciences 
Address  Room no. 481, 4th floor, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar New Delhi


DELHI
110029
India 
Phone  9810856988  
Fax    
Email  namrata.sharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Namrata Sharma 
Designation  Professor 
Affiliation  Dr. R. P. Centre for Ophthalmic Sciences 
Address  Room no. 481, 4th floor, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar New Delhi


DELHI
110029
India 
Phone  9810856988  
Fax    
Email  namrata.sharma@gmail.com  
 
Source of Monetary or Material Support  
BIOTECH EUROPE MEDITECH 
 
Primary Sponsor  
Name  BIOTECH EUROPE MEDITECH 
Address  UNIT AF2 IDA BUSINESS & TECHNOLOGY PARK GALLOWSTOWN Co ROSCOMMON F42 P862 IRELAND 
Type of Sponsor  Other [INTRAOCULAR IMPLANT MANUFACTURER] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Namrata Sharma  Dr. R. P. Centre for ophthalmic sciences  Rooms no. 481, 4th Floor Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi 110029
South
DELHI 		 9810856988

namrata.sharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE AIIMS NEW DELHI 110029  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 
Intervention  cataract surgery with intraocular trifocal lens implantation  cataract surgery with intraocular trifocal lens implantation(optiflex trio) which will remain in the patients eye permanently to provide spectacle-free and clear vision throughout his/her life 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patient with bilateral age related senile cataract
2. grade of cataract permitting optical biometry
3. no ocular/systemic contraindication for surgery
4. a patient with preoperative corneal astigmatism less than 1D in each eye
5. normal macular functions with normal anantomy of macula as seen on optical coherence tomography
6. no history or evidence of ocular anatomical or functional disorders other than cataract including strabismus neuro-ophthalmological disorders of optic nerve or high visual functions corneal pathologies disorders of uvea vitreous pathologies retinal disorders
7. no systemic contraindications to surgery under local anaesthesia
8. patient willing to undergo the investigations and comply with the follow-up schedule 
 
ExclusionCriteria 
Details  1. cataract precluding optical biometry
2. posterier-segment pathology
3. media opacity other than cataract
4. corneal higher order aberrations more than 0.3 micron as measured on ray-tracing wavefront aberrometer
5. patients with potential for intraoperative complications such as floppy iris syndrome and pseudo-exfoliation syndrome
6. cases where intra-operative complications compromise IOL placement with proper centration in the capsule bag
7. patient unwilling to undergo the required investigations or follow-up 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. visual acuity
uncorrected and best corrected distance intermediate and near visual acuity
2. quality of vision 		 1. Pre-operative visit
2. Operative visit
3. Post-operative visit 1 - Day 1
4. Post-operative visit 2 - 1 month
3. Post-operative visit 3 - 3 months
3. Post-operative visit 4 - 6 months
3. Post-operative visit 5 - 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/01/2022 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [namrata.sharma@gmail.com].

  6. For how long will this data be available start date provided 01-06-2023 and end date provided 01-06-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This study is being conducted to evaluate the visual performance of a Trifocal Intraocular lens which has become recently available in India for correction of presbyopia after cataract extraction. The study is a post marketing clinical surveillance 
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