Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
Recruiting · NCT06549023 · Interventional (participants receive a specific treatment) · Lead sponsor: Vastra Gotaland Region
View the official record on ClinicalTrials.gov →Interventions studied
Multiple-session panretinal PRP (MS-PRP)Single-session panretinal PRP (SS-PRP)
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Ögonmottagning Mölndal/SU - Mölndal, Sweden