Retinal perfusion and varying IOP levels during cataract surgery
Phase 4
- Conditions
- Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
- Registration Number
- CTRI/2023/11/060210
- Lead Sponsor
- Alcon Laboratories USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age-related cataract with coexisting diabetic retinopathy (mild, moderate nonproliferative diabetic retinopathy with or without diabetic retinopathy)
Exclusion Criteria
Proliferative diabetic retinopathy with tractional disease or proliferative vitreoretinopathy
Prior ocular trauma or surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For Posterior Pole (macula) perfusion: Retinal vessel density & Perfusion density at superficial retinal layers at the posterior pole detected by OCTA at the following time points: within 2 hours of surgery, 1 day & 1 month postoperativelyTimepoint: 1) 1 day postoperatively - To capture OCT angiography, anterior chamber inflammation <br/ ><br> <br/ ><br>2) 1 week postoperativelyTo document anterior chamber inflammation <br/ ><br>3) 1 month postoperativelyTo document OCT angiography <br/ ><br>
- Secondary Outcome Measures
Name Time Method For Optic nerve head perfusion: Perfusion & Flux index at the RPC layer detected by OCTA at the following time points: within 2 hours of surgery, 1 day & 1 month postoperativelyCumulative Dissipated Energy <br/ ><br>Fluid Used <br/ ><br>Patient comfort during surgery (VAS scale) <br/ ><br>Anterior chamber inflammation: measured on the slitlamp on postoperative day 1 & week 1 <br/ ><br>Timepoint: None