跳至主要内容
临床试验/NCT04648124
NCT04648124招募中不适用

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

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Localization and characterization of neural networks

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Localization and characterization of neural networks

时间窗: baseline

neuronal networks description using rest and morphological functionnal MRIs

Evolution of neuronal networks after retinal implantation

时间窗: baseline

neuronal networks description using rest and morphological functionnal MRIs

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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