Skip to content

Retinal perfusion and varying IOP levels during cataract surgery

Clinical evaluation of retinal perfusion when performing cataract surgery with low vs high preset IOP in eyes with diabetic retinopathy - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060210
Enrollment
80
Registered
2023-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere

Interventions

Intervention1: effect of Phacoemulsification using a physiological IOP(20mmHg) and a high IOP (55 mmHg): Cataract Surgery on the Centurion Vision System with Active Fluidics and Active Sentry handpie

Sponsors

Alcon Laboratories USA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age-related cataract with coexisting diabetic retinopathy (mild, moderate nonproliferative diabetic retinopathy with or without diabetic retinopathy)

Exclusion criteria

Exclusion criteria: Proliferative diabetic retinopathy with tractional disease or proliferative vitreoretinopathy Prior ocular trauma or surgery

Design outcomes

Primary

MeasureTime frame
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 2) 1 week postoperativelyTo document anterior chamber inflammation 3) 1 month postoperativelyTo document OCT angiography

Secondary

MeasureTime frame
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 postoperatively Cumulative Dissipated Energy Fluid Used Patient comfort during surgery (VAS scale) Anterior chamber inflammation: measured on the slitlamp on postoperative day 1 & week 1 Timepoint: None

Countries

India

Contacts

Public ContactDr Abhay R Vasavada

Raghudeep Eye Hospital

icirc@abhayvasavada.com9825700378

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026