Clinical Study of Hydrophilic, Hydrophobic and PMMA intraocular lenses
Phase 3
- Conditions
- Health Condition 1: H590- Disorders of the eye following cataract surgery
- Registration Number
- CTRI/2021/11/038257
- Lead Sponsor
- Ophthalmic Marketing and Services Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult
-Subjects who have already undergone cataract surgery using IOL
-Calculated IOL power is within the range of the investigational IOL (+ 6.0 to 35.0 Diopter)
-Subjects available after contact and willing to come for follow up during the clinical study.
-Subjects with signed informed consent
Subject having clear intraocular media other than cataract
Exclusion Criteria
-Patients unwilling to participate in the study
-Subject with previous intraocular or corneal surgery
-Subject having 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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the intraoperative Safety and Performance of the IOLTimepoint: one year
- Secondary Outcome Measures
Name Time Method To determine the presence of lens related adverse events/residual risks and the visual acuity in the individuals on whom the device was implanted.Timepoint: 1 Year