Micropulsed Laser Treatment for Swelling in the Retina Caused by Inherited Retinal Disease
Tests a gentle micropulsed laser to reduce macular swelling in people with inherited retinal dystrophy.
Plain-language title generated from the registry record
Registry title: Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
Key facts
- Where
- Rome, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05976139, who can take part
Where in Italy
- IRCSS Fondazione G:B:BiettiRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione G.B. Bietti, IRCCS
- Trial code
- NCT05976139
- Record updated
- 28 February 2025
- Original description
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.Read full original descriptionShow less
Treatment of Macular Oedema in Patients With Hereditary Retinal Dystrophies by Applying the Micropulsed Subthreshold Laser
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
Inclusion: 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: Patients with cataract extraction prior to 6 months; Patients with current or previous vitreo-retinal pathology or with indication for vitreo-retinal surgical therapy (tractional oedema); Patients with diabetes; Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration; Patients with IOP ≥ 20 mmHg; Patients with a clinical diagnosis of retinal dystrophy of unproven genetic origin; Patients with a lack of target fixation at 32 cm; Pregnant women.