NCT05976139Recruiting
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
Source: ClinicalTrials.gov · Last updated 28 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 19 Jul 2023
- Start date
- 6 Sept 2023
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT05976139
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 6 Sept 2023 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Patients with diabetes
Age
- Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCSS Fondazione G:B:Bietti Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.