Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFondazione G.B. Bietti, IRCCS
About this trial
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
Eligibility criteria
Qualifiers
Patients with inherited retinal disease
Age between 18 and 80 years
Conclusive molecular genetic study for IRD
Male or female patient
Disqualifiers
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
Trial design
Treatments tested in this trial
- subthreshold treatment with micropulsed laser
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov