RecruitingNot ApplicableNCT05976139

Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

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


Sponsor

Fondazione G.B. Bietti, IRCCS

Enrollment

10 participants

Start Date

Sep 6, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called subthreshold treatment with micropulsed laser for people with inherited retinal dystrophy, laser retinopathy, and other related conditions. The study is currently recruiting participants at 1 location.

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

DEVICEsubthreshold 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

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NCT05976139


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