Health Condition 1: H25- Age-related cataract
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Trillium MediVision Inc
Eligibility
Inclusion criteria
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
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, irregular astigmatism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Assess the intraoperative Safety and Performance of the IOL.Timepoint: Timepoints-3 years There will be 5 follow up visits expected after the implantation of Intraocular Lens: 1st Visit - After 1d to 2d post operatively 2nd Visit - After 7d to 14d post operatively 3rd Visit - After 30d to 60d post operatively 4th Visit - After 120d to 180d post operatively 5th visit - After 330 days of implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Timepoints-3 years There will be 5 follow up visits expected after the implantation of Intraocular Lens: 1st Visit ? After 1d to 2d post operatively 2nd Visit - After 7d to 14d post operatively 3rd Visit - After 30d to 60d post operatively 4th Visit - After 120d to 180d post operatively 5th visit - After 330 days of implantation | — |
Countries
India
Contacts
Public ContactMrs Linu Thommi
Jothi Laser Eye Hospital,Tamil Nadu
Outcome results
None listed