Comparing single-session and multiple-session laser treatment for diabetic eye disease
Official title: Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study
Run by Vastra Gotaland Region · NCT06549023 · Data updated 2026-11-12
This study is testing whether one session or multiple sessions of laser treatment works better for people with newly diagnosed diabetic eye disease to help them keep their vision and avoid complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Mölndal) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT06549023 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old with type 1 or type 2 diabetes and newly diagnosed proliferative diabetic retinopathy.
✕Probably not a fit
Patients who have had recent eye surgery, previous treatments for diabetic macular edema, or other complicating medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the safety and effectiveness of single-session versus multiple-session panretinal photocoagulation (PRP) in treating proliferative diabetic retinopathy (PDR), a leading cause of blindness in working-age adults. Both treatment approaches are commonly used, but their comparative outcomes remain debated. The study will include patients with newly diagnosed PDR and will assess visual acuity and retinal health following treatment. The goal is to determine which method is more beneficial for preserving vision and reducing complications.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines on the optimal treatment approach for patients with proliferative diabetic retinopathy, potentially improving visual outcomes.
How similar studies have gone: Previous studies have shown mixed results regarding the effectiveness of single versus multiple-session PRP, indicating that this study could provide valuable insights into an ongoing debate.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Ögonmottagning Mölndal/SU
Mölndal, Sweden Recruiting
Study contacts
- Principal investigator: Marita Andersson Grönlund, M.D. Prof — Göteborg University
- Study coordinator: Imadeddin Abu Ishkheidem, M.D.
- Email: imadeddin.abu.ishkheidem@vgregion.se
- Phone: +46738744867
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Predictive CGM with App for people with type 1 or insulin-treated type 2 diabetes
This study tests whether using the Accu-Chek SmartGuide CGM with its Predict App can reduce fear of hypoglycemia and improve related behaviors and confidence in adults with type 1 or insulin-treated type 2 diabetes.
-
Diabetes multimorbidity and a voice diary app to help self-manage
This study tests whether the Fabla-diabetesMM audio diary app is feasible and helpful for older adults with type 1 or type 2 diabetes who also have additional chronic conditions.
-
Tracking retinal changes over two years in people with moderate to early proliferative diabetic retinopathy
This project will try to find imaging, functional, and blood markers that show whether retinopathy is getting worse over two years in people with type 2 diabetes and moderate-to-mildly advanced disease.
-
Eversense Gemini system with new flash glucose feature — testing accuracy and safety
This will test whether the Eversense Gemini wearable glucose monitor with a new flash feature gives accurate and safe glucose readings for adults with type 1 or type 2 diabetes.
-
Evaluating LY4057996 in Healthy Individuals and Those with Type 1 and Type 2 Diabetes
This study is testing a new drug called LY4057996 to see how well it is tolerated and what side effects it might have in healthy people and those with Type 1 or Type 2 diabetes.
-
Remote ischemic conditioning to treat early diabetic retinopathy
This trial will test whether remote ischemic conditioning — brief, repeated arm cuff inflations — helps adults aged 40–80 with mild-to-moderate non-proliferative diabetic retinopathy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.