RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * 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.

Treatments Being Tested

PROCEDURE

Single-session panretinal PRP (SS-PRP)

Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas in one comprehensive session, typically delivered in a single clinical visit.

PROCEDURE

Multiple-session panretinal PRP (MS-PRP)

Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas over two separate visits with at least one week apart.

Locations (1)

Ögonmottagning Mölndal/SU

Mölndal, Sweden