Retinal Inflammation, Cell Death and Inherited Retinal Dystrophies.
Lorena Olivares-González, Sheyla Velasco, Isabel Campillo...
https://pubmed.ncbi.nlm.nih.gov/33672611Actively Recruiting
Led by Fondazione G.B. Bietti, IRCCS · Updated on 2025-02-28
10
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the use of subthreshold micropulsed laser treatment to reduce macular edema in patients with inherited retinal dystrophies, a group of rare eye diseases that cause progressive vision loss. Macular edema can worsen vision in these patients, and current treatments like diuretics and injections have limitations and potential side effects. This study seeks to determine if micropulsed laser therapy, which uses low energy to avoid retinal damage, can help resolve this condition. The treatment uses a specific micropulsed laser device with defined power, pulse duration, and spot size settings. Patients receive laser treatment on the first visit, with possible repeat treatments between 3 and 12 months based on response. This prospective, open-label study enrolls patients who have persistent macular edema despite prior treatments such as diuretics or anti-VEGF injections. Participants will be followed for up to 24 months with scheduled visits at 1, 3, 6, 9, 12, 18, and 24 months after treatment. At these visits, comprehensive eye exams will be performed including OCT imaging, electroretinograms, and retinography. Researchers will measure changes in central retinal thickness and assess visual acuity, retinal function, and blood flow to evaluate treatment effects and safety over time.
CONDITIONS
Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive treatment with subthreshold micropulsed laser to reduce macular oedema in inherited retinal dystrophies.
1 baseline visit and 7 follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months
Total: 1 location
1
IRCSS Fondazione G:B:Bietti
Rome, RM, Italy, 00194
Actively Recruiting
L
Lucia Ziccardi, MD, PhD
F
Federica Petrocchi, Orthoptist
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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