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

Sponsor
Vastra Gotaland Region
Study ID
NCT06549023
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Single-session panretinal PRP (SS-PRP) — PROCEDURE
    Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas in one comprehensive session, typically delivered in a single clinical visit.
  • Multiple-session panretinal PRP (MS-PRP) — PROCEDURE
    Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas over two separate visits with at least one week apart.

Study Details

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.

Key Dates

First listed
Aug 12, 2024
Start date
Jan 1, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Single-session panretinal PRP (SS-PRP)
    Administration of all panretinal photocoagulation (PRP) treatment in one comprehensive session, typically delivered in a single clinical visit.
  • Active Comparator: Multiple-session panretinal PRP (MS-PRP)
    Administration of panretinal photocoagulation (PRP) treatment over two separate visits with at least one week apart.

Primary Outcome Measure

Central subfield retinal thickness (CRT) [ Time Frame: Baseline and 1, 3 and 6 months after treatment ]

Central Contacts

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