To evaluate the clinical parameters demonstrating the performance of the Active Sentry in two different pressure ( 20 & 50 mm of Hg) settings. This is a prospective, comparative, double arm, and single centre study.
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/10/058235
- Lead Sponsor
- Alcon Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 112
Inclusion Criteria
Cataract grade NS2 as per LOCS classification, Pupil dilatation > 6mm, ACD 2.6mm-4.5mm
Exclusion Criteria
any other ocular pathology,intra operative and post operative complications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in CCT pre and post operativeTimepoint: pre op ( baseline ) and post op day 1
- Secondary Outcome Measures
Name Time Method BCVATimepoint: Post op Day 1;ECDTimepoint: Post op day 1 <br/ ><br>post op 1 month and <br/ ><br>post op 3 months