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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT04648124
Collaborator
(none)
200
1
65.8
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: IRMf-r (séquence resting state)

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Patients for whom there is no planned implant surgery

Device: IRMf-r (séquence resting state)
Functional MRI of functional brain networks

Patients for whom implantation surgery is planned

Device: IRMf-r (séquence resting state)
Functional MRI of functional brain networks

case

Device: IRMf-r (séquence resting state)
Functional MRI of functional brain networks

Outcome Measures

Primary Outcome Measures

  1. Localization and characterization of neural networks [baseline]

    neuronal networks description using rest and morphological functionnal MRIs

  2. Evolution of neuronal networks after retinal implantation [baseline]

    neuronal networks description using rest and morphological functionnal MRIs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondation Adolphe de Rothschild Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT04648124
Other Study ID Numbers:
  • ALR_2020_30
First Posted:
Dec 1, 2020
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2022