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CTRI Number  CTRI/2023/04/052103 [Registered on: 28/04/2023] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Intraocular lens is a lens implanted in the eye as part of a treatment for cataracts or myopia 
Scientific Title of Study   Study to evaluate safety and performance of Intraocular Lenses  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No: TMVI/CIP-IND, Rev No: 00, DATE: 12/01/2023   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Venkatesh Shyam Sundar  
Designation  Ophthalmologist 
Affiliation  Jothi Laser Eye Hospital,Tamil Nadu 
Address  Jothi Laser Eye Hospital,ground floor,Room No 2, 110, Duraisamy Naidu St, Dharmapuri, Tamil Nadu 636701, India

Dharmapuri
TAMIL NADU
636701
India 
Phone  9345146646   
Fax    
Email  drv2772@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Venkatesh Shyam Sundar  
Designation  Ophthalmologist 
Affiliation  Jothi Laser Eye Hospital,Tamil Nadu 
Address  Jothi Laser Eye Hospital,ground floor,Room No 2, 110, Duraisamy Naidu St, Dharmapuri, Tamil Nadu 636701, India

Dharmapuri
TAMIL NADU
636701
India 
Phone  9345146646   
Fax    
Email  drv2772@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mrs Linu Thommi 
Designation  CRO 
Affiliation  Dr.Klinisch Research Pvt Ltd 
Address  Dr.Klinisch Research Pvt Ltd,3rd floor, No: 1035 Prihan Plaza, 12th Main Road, AECS ‘B’ Block, Singasandra Bengaluru

Bangalore Rural
KARNATAKA
560068
India 
Phone    
Fax    
Email  linu@drklinisch.com  
 
Source of Monetary or Material Support  
Trillium MediVision Inc,1707 Sismet Road Unit #9 Mississauga, ON L4W2K8 Canada  
 
Primary Sponsor  
Name  Trillium MediVision Inc. 
Address  1707 Sismet Road Unit #9 Mississauga, ON L4W2K8 Canada. Critical supplier Address-Freedom Ophthalmic Pvt. Ltd. Plot No. 31, Phase -I, SIPCOT Industrial Complex, Hosur – 635126, Tamil Nadu, INDIA  
Type of Sponsor  Other [Private Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Bolivia
Dominican Republic
Venezuela (Bolivarian Republic of)  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venkatesh Shyam Sundar   Jothi Laser Eye Hospital   Ground floor,Room No 2, Jothi Laser Eye Hospital 110, Duraisamy Naidu St, Dharmapuri, Tamil Nadu 636701, India
Dharmapuri
TAMIL NADU 		 9345146646

drv2772@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
RIPON INDEPENDENT ETHICS COMMITTEE  Approved 
RIPON INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H25||Age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  adult; - cataract; - calculated IOL power is within the range of the investigational IOL; - signed informed consent form; and - clear intraocular media other than cataract
 
 
ExclusionCriteria 
Details  previous intraocular or corneal surgery,
traumatic cataract,
pregnancy or lactation,
concurrent participation in another drug or device investigation,
instability of keratometry or biometry measurements,
irregular astigmatism.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Assess the intraoperative Safety and Performance of the IOL.   1 Year
There will be 5 follow up visits expected after the implantation of Intraocular Lens:
1st Visit - After 2 days of surgery
2nd Visit - After 2 weeks of surgery
3rd Visit - After 2 months of surgery
4th Visit - After 6 months of surgery
5th visit – After 1 year of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the presence of lens related adverse events/residual risks in the individuals on whom the device was implanted. The following adverse events/residual risks shall be considered for the clinical investigation.   1 year
There will be 5 follow up visits expected after the implantation of Intraocular Lens:
1st Visit - After 2 days of surgery
2nd Visit - After 2 weeks of surgery
3rd Visit - After 2 months of surgery
4th Visit - After 6 months of surgery
5th visit – After 1 year of surgery  
 
Target Sample Size   Total Sample Size="340"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   22/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/05/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Study Title-Study to evaluate safety and performance of Intraocular Lenses.

The purpose of the study is to evaluate safety and performance of Intraocular Lenses.

Duration of study will be one year. 

Primary Endpoint:  To Assess the intraoperative Safety and Performance of the hydrophobic IOL.

Secondary Endpoint: To determine the presence of lens related adverse events/residual risks in the individuals on whom the devices were implanted. 

Inclusion Criteria 
 
Adult;
cataract; 
calculated IOL power is within the range of the investigational IOL; 
signed informed consent form; and 
clear intraocular media other than cataract. 

Exclusion Criteria 
 
Previous intraocular or corneal surgery; 
traumatic cataract; 
pregnancy or lactation; 
concurrent participation in another drug or device investigation; 
instability of keratometry or biometry measurements; and 
irregular astigmatism. 
There will be 5 follow up visits expected after the implantation of Intraocular Lens:  
1st Visit - After 2 days of surgery 
2nd Visit - After 2 weeks of surgery 
3rd Visit - After 2 months of surgery 
4th Visit - After 6 months of surgery 
5th visit – After 1 year of surgery 

Subject selection: 
Subjects who are indicated for cataract surgery will be selected for the study. 

Sample Size:
150 subjects will be recruited 
 
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