Actively Recruiting
Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
Led by Fondazione G.B. Bietti, IRCCS · Updated on 2025-02-28
10
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with inherited retinal disease
- Age between 18 and 80 years
- Confirmed molecular genetic diagnosis of inherited retinal dystrophy
- Male or female patients
- Presence of macular edema with less than or equal to 20% reduction after 3 months of diuretics or draining supplements, or 4 months after last anti-VEGF or steroid injection
- Phakic or pseudophakic status
- Central retinal thickness greater than 320 microns in men and greater than 305 microns in women
- Informed consent given before the study
- Ability and willingness to follow study instructions and complete all required visits and procedures
You will not qualify if you...
- Cataract extraction within the previous 6 months
- Intraocular pressure equal to or greater than 20 mmHg
- Retinal dystrophy without proven genetic origin
- Diabetes
- Central serous chorioretinopathy, retinal vein occlusion, or age-related degeneration
- Current or prior vitreoretinal disease or need for vitreoretinal surgery
- Inability to maintain target fixation at 32 cm
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCSS Fondazione G:B:Bietti
Rome, RM, Italy, 00194
Actively Recruiting
Research Team
L
Lucia Ziccardi, MD, PhD
CONTACT
F
Federica Petrocchi, Orthoptist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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