Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study
Vastra Gotaland Region
40 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
Summary
Proliferative diabetic retinopathy (PDR) is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR is panretinal photocoagulation (PRP). In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The purpose of this study is to compare the safety and effectiveness of single-session and multiple-session PRP.
Eligibility
Inclusion Criteria5
- Age \> 18 years.
- Patients with type 1 or type 2 Diabetes Mellitus with newly diagnosed Proliferative Diabetic Retinopathy, PDR.
- Visual acuity ≥ 0.1 Snellen.
- CRT of less than 300 micrometer measured by OCT without cysts in the neuroretina.
- Clear media and adequately dilated pupil for PRP.
Exclusion Criteria6
- Intraocular surgery within the last 4 months or planned within the next 3 months.
- Previous or current center-involved diabetic macular edema (Ci-DME).
- Previous PRP, intravitreal treatment (IVT), or macular laser treatment in study eye.
- Treatment with medications known to risk macular edema.
- Media opacity preventing adequate PRP.
- General medical condition making office laser treatment very difficult or impossible.
Interventions
Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas in one comprehensive session, typically delivered in a single clinical visit.
Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas over two separate visits with at least one week apart.
Locations(1)
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NCT06549023