VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies

Recruiting

• Conditions: Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies
• Interventions: Device: IRMf-r (séquence resting state)

• Registration Number: NCT04648124
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-01
• Study Start: 2021-01-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-11
• Primary Completion: 2024-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients for whom implantation surgery is planned	IRMf-r (séquence resting state)	-
case	IRMf-r (séquence resting state)	-
Patients for whom there is no planned implant surgery	IRMf-r (séquence resting state)	-

Primary Outcome Measures

Name	Time	Method
Localization and characterization of neural networks	baseline	neuronal networks description using rest and morphological functionnal MRIs
Evolution of neuronal networks after retinal implantation	baseline	neuronal networks description using rest and morphological functionnal MRIs

Trial Locations

Locations (1)

Fondation Adolphe de Rothschild; 🇫🇷 Paris, France