Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

Launched by FONDAZIONE G.B. BIETTI, IRCCS · Jul 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special type of laser treatment called micropulsed laser on patients who have macular edema due to inherited retinal dystrophies. The main goal is to see if this laser treatment can help reduce swelling in the macula, which is an important part of the eye that affects vision. The trial is open to adults aged 18 to 80 who have been diagnosed with inherited retinal disease and have specific measures of macular edema. Participants must have a certain level of retinal thickness and must have tried other treatments without significant improvement.

If you decide to participate, you will receive the laser treatment during your first visit. After that, you will have follow-up visits at various intervals for up to two years to monitor your eye health and the effects of the treatment. These visits will involve several eye examinations to check how your eyes are responding to the treatment. It’s important to know that not everyone is eligible; for example, people with certain eye conditions, diabetes, or who are pregnant cannot join this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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
• • Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration
• • Patients with current or previous vitreo-retinal pathology or with indication for vitreo-retinal surgical therapy (tractional oedema)
• • Patients with a lack of target fixation at 32 cm
• • Pregnant women