Comparing single-session and multiple-session laser treatment for diabetic eye disease
Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study
NA · Vastra Gotaland Region · NCT06549023
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region (other gov) |
| Locations | 1 site (Mölndal) |
| Trial ID | NCT06549023 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mölndal
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Proliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabetic Retinopathy Visually Threatening, Diabetic Macular Edema, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Panretinal photocoagulation, Single-session PRP