Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
NCT Number: NCT06549023
Acronym: SMART-PRP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Proliferative Diabetic Retinopathy|Diabetic Retinopathy|Diabetic Retinopathy Visually Threatening|Diabetic Macular Edema|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: PROCEDURE: Single-session panretinal PRP (SS-PRP)|PROCEDURE: Multiple-session panretinal PRP (MS-PRP)
Sponsor: Vastra Gotaland Region
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2030-12-31

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.

Primary Outcome Measures: Central subfield retinal thickness (CRT), Mean change from baseline in CRT, Baseline and 1, 3 and 6 months after treatment|Vessel Perfusion Density (VPD), Mean change from baseline in VPD, Baseline and 1, 3 and 6 months after treatment|Vessel Length Density (VLD), Mean change from baseline in VLD, Baseline and 1, 3 and 6 months after treatment|Foveal Avascular Zone (FAZ), Mean change from baseline in FAZ, Baseline and 1, 3 and 6 months after treatment|Lesion size, Mean change from baseline in lesion size, Baseline and 1, 3 and 6 months after treatment|Macular volume, Mean change from baseline in macular volume, Baseline and 1, 3 and 6 months after treatment|Venular saturation, Mean change from baseline in venular saturation, Baseline and 1, 3 and 6 months after treatment|Arteriolar saturation, Mean change from baseline in arteriolar saturation, Baseline and 1, 3 and 6 months after treatment|Retinal diameter, Mean change from baseline in retinal diameter, Baseline and 1, 3 and 6 months after treatment|Venular diameter, Mean change from baseline in venular diameter, Baseline and 1, 3 and 6 months after treatment|Retinal function, Mean change from baseline in retinal function using full-field electroretinogram (ERG), Baseline and 1, 3 and 6 months after treatment|Diabetic macular edema (DME), Incidence of diabetic macular edema (DME), Baseline and 1, 3 and 6 months after treatment|Subjective experience of pain after treatment, Study patients' subjective experience of pain after treatment using visual analog scale (VAS), Baseline and 1, 3 and 6 months after treatment|Subjective overall experience of the treatment, Study patients' subjective overall experience of the treatment using verbal scale (VS), Baseline and 1, 3 and 6 months after treatment|Cost-effectiveness, We intend to conduct a thorough cost-effectiveness analysis, comparing the single-session approach with the traditional multiple-session treatments.

This analysis will factor in direct medical costs, including the expenses related to the laser equipment, healthcare professionals' time, and the required clinical facilities. We will also consider indirect costs such as patient travel expenses and time taken off work., Baseline and 1, 3 and 6 months after treatment