Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies Clinical Trial
— VICTOIREOfficial title:
VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies
| NCT number | NCT04648124 |
| Other study ID # | ALR_2020_30 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 4, 2021 |
| Est. completion date | July 2026 |
The Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. In order to plan the MRI on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). If patients agree to participate in the study, rMRI will be scheduled. During the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | July 2026 |
| Est. primary completion date | January 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient over 18 years old - Diagnostic clinique de dystrophie rétinienne héréditaire ou maculopathie héréditaire, syndromique ou non syndromique - Artificial vision treatment such as a retinal implant, or optogenetics scheduled in the next 6 months - Express consent to participate in the study - Affiliate or beneficiary of a social security scheme Exclusion Criteria: - Patient benefiting from a legal protection measure - Pregnant or breastfeeding woman - Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker). - Other additional ocular pathology that can significantly affect vision - Recent eye surgery less than 3 months old |
| Country | Name | City | State |
|---|---|---|---|
| France | Fondation Adolphe de Rothschild | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Localization and characterization of neural networks | neuronal networks description using rest and morphological functionnal MRIs | baseline | |
| Primary | Evolution of neuronal networks after retinal implantation | neuronal networks description using rest and morphological functionnal MRIs | baseline |