RecruitingNot ApplicableNCT06549023

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

Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study


Sponsor

Vastra Gotaland Region

Enrollment

40 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to panretinal photocoagulation (PRP) — a laser treatment for a serious eye complication of diabetes called proliferative diabetic retinopathy (PDR). PDR occurs when abnormal blood vessels grow in the retina and can lead to vision loss. The study is comparing doing all the laser treatment in a single session versus spreading it out over multiple sessions to see which approach is safer and equally effective. **You may be eligible if...** - You are over 18 years old with type 1 or type 2 diabetes - You have been newly diagnosed with proliferative diabetic retinopathy (PDR) - You have usable vision in the study eye (visual acuity 0.1 or better on the Snellen chart) - Your retina is not too swollen (OCT thickness under 300 micrometers) - Your pupil can be dilated adequately and the media is clear enough for laser treatment **You may NOT be eligible if...** - You have had eye surgery in the last 4 months or have surgery planned in the next 3 months - You have diabetic macular edema affecting the center of your vision - You have previously received PRP, injections into the eye, or macular laser in this eye - You take medications known to cause macular edema - You have a condition making office laser treatment unsafe or very difficult Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESingle-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.

PROCEDUREMultiple-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.


Locations(1)

Ögonmottagning Mölndal/SU

Mölndal, Sweden

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NCT06549023


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