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RID: Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03691168
Collaborator
(none)
500
Enrollment
1
Location
59.9
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Based on a clinical multi-center study of the natural course of inherited retinal dystrophies in Chinese population, screening fundus imaging indicators for patients with Chinese inherited retinal dystrophies, describing the clinical features of Chinese patients with inherited retinal dystrophies, and establishing a diagnosis of hereditary retinal diseases - Follow-up norms; establish a network-based multi-center diagnosis and follow-up platform; obtain a biological sample library of hereditary retinal diseases mainly in China. The research will further improve and enrich the genotype, phenotypic characteristics and natural course of Chinese inherited retinal dystrophies, in order to promote the clinical evaluation of clinical inherited retinal dystrophies and the standardization of genetic diagnosis. It is also the evidence for the best timing for future gene therapy, to obtain the best therapeutic effect, and to provide a theoretical basis for achieving precise treatment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies
    Actual Study Start Date :
    Jun 1, 2018
    Anticipated Primary Completion Date :
    May 30, 2019
    Anticipated Study Completion Date :
    May 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [60 months]

      A typical Snellen chart that if frequently used for visual acuity testing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients with IRDs whose mutations have been identified

    2. 4~70 years old

    3. Complete 4 basic examinations of the eye: Corrective vision; fundus photography; OCT; ERG

    Exclusion Criteria:

    1. Has participated in other interventional treatment studies;

    2. Patients with severe systemic diseases, mental dysplasia, mental illness;

    3. Unable to accept eye examination patients;

    4. Traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis

    5. At the initial visit, the patient's binocular vision is displayed as no light.

    6. Both eyes have a history of internal eye surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai General Hospital Shanghai Shanghai China 200080

    Sponsors and Collaborators

    • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    Investigators

    • Principal Investigator: XiaoDong Sun, PHD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaodong Sun, Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03691168
    Other Study ID Numbers:
    • Shanghai1stSXD
    First Posted:
    Oct 1, 2018
    Last Update Posted:
    Oct 1, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiaodong Sun, Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    Inherited retinal dystrophies, Gene screen
    Additional relevant MeSH terms:
    Retinal Dystrophies

    Study Results

    No Results Posted as of Oct 1, 2018