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

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.

Study Overview

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Paris, France, 75019
        • Recruiting
        • Fondation Adolphe de Rothschild
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hereditary retinal dystrophies whether or not to undergo implantation surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case
Functional MRI of functional brain networks
Patients for whom there is no planned implant surgery
Functional MRI of functional brain networks
Patients for whom implantation surgery is planned
Functional MRI of functional brain networks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Localization and characterization of neural networks
Time Frame: baseline
neuronal networks description using rest and morphological functionnal MRIs
baseline
Evolution of neuronal networks after retinal implantation
Time Frame: baseline
neuronal networks description using rest and morphological functionnal MRIs
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Augustin LECLER, Fondation Ophtalmologique A. de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (Actual)

December 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ALR_2020_30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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