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

September 28, 2018 updated by: Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • 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

4 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with inherited retinal dystrophies

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 60 months
A typical Snellen chart that if frequently used for visual acuity testing
60 months

Collaborators and Investigators

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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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)

June 1, 2018

Primary Completion (ANTICIPATED)

May 30, 2019

Study Completion (ANTICIPATED)

May 30, 2023

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (ACTUAL)

October 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shanghai1stSXD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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