Recruiting

Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy

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.

ClinicalTrials.gov IDNCT06549023

PhaseNA

Enrollment40

SponsorVastra Gotaland Region

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Proliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabetic Retinopathy Visually Threatening, Diabetic Macular Edema, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

About this study

Interventions

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.

Primary outcomes

Central subfield retinal thickness (CRT) (Baseline and 1, 3 and 6 months after treatment)
Vessel Perfusion Density (VPD) (Baseline and 1, 3 and 6 months after treatment)
Vessel Length Density (VLD) (Baseline and 1, 3 and 6 months after treatment)
Foveal Avascular Zone (FAZ) (Baseline and 1, 3 and 6 months after treatment)
Lesion size (Baseline and 1, 3 and 6 months after treatment)
Macular volume (Baseline and 1, 3 and 6 months after treatment)
Venular saturation (Baseline and 1, 3 and 6 months after treatment)
Arteriolar saturation (Baseline and 1, 3 and 6 months after treatment)

Eligibility information

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.

Study locations

Ögonmottagning Mölndal/SU, Mölndal, 43130 Sweden

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.