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RECRUITING
NCT05976139
NA

Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

Sponsor: Fondazione G.B. Bietti, IRCCS

View on ClinicalTrials.gov

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

Official title: Treatment of Macular Oedema in Patients With Hereditary Retinal Dystrophies by Applying the Micropulsed Subthreshold Laser

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-09-06

Completion Date

2025-07-30

Last Updated

2025-02-28

Healthy Volunteers

No

Interventions

DEVICE

subthreshold treatment with micropulsed laser

The laser instrument used is the Q 577® Laser System, Iridex, wavelength 577 yellow. The standard pattern used is: * Power: 5% Duty Cycle * Power 250 mw * Pulse duration 200 ms * Spot size 100 micron * Pattern spacing 0.0 confluente, griglie 7x7

Locations (1)

IRCSS Fondazione G:B:Bietti

Rome, RM, Italy