Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies
| Tracking Information | |||
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| First Submitted Date ICMJE | September 28, 2018 | ||
| First Posted Date ICMJE | October 1, 2018 | ||
| Last Update Posted Date | October 1, 2018 | ||
| Actual Study Start Date ICMJE | June 1, 2018 | ||
| Estimated Primary Completion Date | May 30, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Visual acuity[ Time Frame: 60 months ] A typical Snellen chart that if frequently used for visual acuity testing |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies |
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| Official Title ICMJE | Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies |
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| 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. |
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| Detailed Description | |||
| Study Type ICMJE | Observational | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational Masking Description: Primary Purpose: |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
500 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | May 30, 2023 | ||
| Estimated Primary Completion Date | May 30, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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 | ||
| Sex/Gender |
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| Ages | 4 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | China | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | ||
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Xiaodong Sun，Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
| Study Sponsor ICMJE | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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