Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorVastra Gotaland Region
Government
Locations1 site (Mölndal)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2030
Registry record updatedNovember 18, 2025
Trial IDNCT06549023 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.