Retinal perfusion and varying IOP levels during cataract surgery
Phase 4
Not yet recruiting
- Conditions
- Retinal disorders in diseases classified elsewhere,
- Registration Number
- CTRI/2023/11/060210
- Lead Sponsor
- Alcon Laboratories USA
- Brief Summary
To study the effect of Phacoemulsification using different IOP settings, IOP 20mmHg and IOP 55 mmHg on the retinal macular circulation in patients having mild non proliferative diabetic retinopathy undergoing cataract surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 80
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 postoperatively 1) 1 day postoperatively - To capture OCT angiography, anterior chamber inflammation | 2) 1 week postoperativelyTo document anterior chamber inflammation | 3) 1 month postoperativelyTo document OCT angiography
- 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 Fluid Used
Trial Locations
- Locations (1)
Raghudeep Eye Hospital
🇮🇳Ahmadabad, GUJARAT, India
Raghudeep Eye Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Abhay VasavadaPrincipal investigator9825700378icirc@abhayvasavada.com