Intraocular lens is a lens implanted in the eye as part of a treatment for cataracts or myopia
- Conditions
- Age-related cataract,
- Registration Number
- CTRI/2023/04/052103
- Lead Sponsor
- Trillium MediVision Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 340
- calculated IOL power is within the range of the investigational IOL;.
- signed informed consent form; and.
- clear intraocular media other than cataract.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Jothi Laser Eye Hospital
🇮🇳Dharmapuri, TAMIL NADU, India
Jothi Laser Eye Hospital🇮🇳Dharmapuri, TAMIL NADU, IndiaDr Venkatesh Shyam SundarPrincipal investigator9345146646drv2772@gmail.com