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Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

RecruitingNAAges 18 Years - 80 YearsAllFondazione G.B. Bietti, IRCCS
NCT05976139 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with inherited retinal disease * Age between 18 and 80 years * Conclusive molecular genetic study for IRD * Male or female patient * Presence of macular oedema assessed by sd-OCT with reduction ≤ 20% after 3 months of diuretics or draining supplements or 4 months after last anti-VEGF or steroid injection * Phakic and pseudophakic patients * Central Retinal thickness \> 320 microns in men and \> 305 microns in women * Informed consent freely granted and acquired before the start of the study * Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures. Exclusion Criteria: * Patients with cataract extraction prior to 6 months * Patients with IOP ≥ 20 mmHg * Patients with a clinical diagnosis of retinal dystrophy of unproven genetic origin * Patients with diabetes * Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration * Patients with current or previous vitreo-retinal pathology or with indication for vitreo-retinal surgical therapy (tractional oedema) * Patients with a lack of target fixation at 32 cm * Pregnant women
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What it tests

  • subthreshold treatment with micropulsed laser
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Where

1 site
IRCSS Fondazione G:B:Bietti
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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