Macular Edema Clinical Trial
Official title:
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
Status | Recruiting |
Enrollment | 10 |
Est. completion date | July 30, 2025 |
Est. primary completion date | July 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCSS Fondazione G:B:Bietti | Rome | RM |
Lead Sponsor | Collaborator |
---|---|
Fondazione G.B. Bietti, IRCCS |
Italy,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | assessment of significative change in retinal oedema compared to baseline | assessment of central retinal thickness by macular SD-OCT | up to 24 months | |
Secondary | To study changes in visual acuity between before and after treatment | LogMAr visual acuity values | up to 24 months | |
Secondary | To study the retinal function in the macular area before and after treatment. | response amplitude density, measured in nV/dg2 and analysed using multifocal electroretinogram, assessing the amplitude in 5 concentric rings centred on the fovea. | up to 24 months | |
Secondary | To study the retinal perfusion of the macular area by OCT-angiography before and after treatment. | vascular density (expressed as Retinal Vessel Density) before and after treatment, using OCT-angiography | up to 24 months |
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