Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies
RID
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedOctober 1, 2018
September 1, 2018
12 months
September 28, 2018
September 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual acuity
A typical Snellen chart that if frequently used for visual acuity testing
60 months
Eligibility Criteria
Patients with inherited retinal dystrophies
You may qualify if:
- Patients with IRDs whose mutations have been identified
- \~70 years old
- Complete 4 basic examinations of the eye: Corrective vision; fundus photography; OCT; ERG
You may not qualify if:
- Has participated in other interventional treatment studies;
- Patients with severe systemic diseases, mental dysplasia, mental illness;
- Unable to accept eye examination patients;
- Traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis
- At the initial visit, the patient's binocular vision is displayed as no light.
- Both eyes have a history of internal eye surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Biospecimen
Blood
Study Officials
- PRINCIPAL INVESTIGATOR
XiaoDong Sun, PHD
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 28, 2018
First Posted
October 1, 2018
Study Start
June 1, 2018
Primary Completion
May 30, 2019
Study Completion
May 30, 2023
Last Updated
October 1, 2018
Record last verified: 2018-09