Clinical Trial

Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 28, 2025 (before its estimated July 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to investigate whether subthreshold treatment with micropulsed laser can be effective in resolving macular edema in patients with inherited retinal dystrophy. Visits will be performed after 1, 3, 6, 9, 12, 18, and 24 months after treatment. Laser treatment will be performed on the day of the first visit, and its repetition at subsequent visits between months 3 and 12 will be evaluated. Evaluations of treatment effects will include: * comprehensive ophthalmologic examination * multifocal electroretinogram * OCT examination * OCT-angiography examination * retinography Primary endpoint. \- central retinal thickness, measured by OCT
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-27; most recent amendment 2025-02-26.
Status change: Not Yet Recruiting → Recruiting 2023-09-12
Trial Details
NCT Number NCT05976139
Lead Sponsor Fondazione G.B. Bietti, IRCCS
Conditions Macular Edema, Inherited Retinal Dystrophy, Laser Retinopathy
Enrollment 10 participants
Start Date 2023-09-06
Primary Completion 2025-07-30 (estimated)
Study Completion 2025-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-28