Status:
RECRUITING
Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
Lead Sponsor:
Fondazione G.B. Bietti, IRCCS
Conditions:
Macular Edema
Inherited Retinal Dystrophy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
BACKGROUND: Degenerative diseases of the visual system classified as rare and, in particular, those affecting the retina (known as Inherited retinal dystrophies, IRDs) cause very severe functional de...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
September 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05976139
Start Date
September 6 2023
End Date
July 30 2025
Last Update
February 28 2025
Active Locations (1)
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1
IRCSS Fondazione G:B:Bietti
Rome, RM, Italy, 00194