Shanghai Children and Adolescent Diabetes Eye Study

Recruiting

• Conditions: Eye Diseases; Diabetes Mellitus
• Interventions: Diagnostic Test: Diabetes mellitus

• Registration Number: NCT03587948
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

To compare the prevalence of eye disease between children and adolescents with diabetes mellitus and healthy people, and to analyze the related factors of eye diseases in diabetic patients.

Detailed Description

A cohort study. From January 2018 to 2028, 300 cases of diabetic children in Children's Hospital of Fudan University in Shanghai will be selected as case group, and 300 healthy children without diabetes will be selected as the control group.

The purpose of the study is to guide and regulate eye health screening of children and adolescents with diabetes in Children's Hospital of Fudan University in Shanghai, build up the ranks with the general practitioner as the backbone combined, and provide comprehensive, continuous, and dynamic information service to diabetic eye disease health management. We expect to reduce the prevalence rate of diabetic eye disease, blindness and visual impairment of DR, and improve diabetics consciousness of eye health maintenance, thus upgrading the level of eye disease prevention and treatment in Shanghai.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-03
• Last Update Submitted: 2018-07-03
• Study First Posted: 2018-07-16
• Last Update Posted: 2018-07-16
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• (1) provision of a written informed consent by a guardian;
• (2) age over 5 years and less than 18 years;
• (3) diagnosis of type 1 or type 2 diabetes based on the WHO diagnostic criteria for cases.

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Exclusion Criteria

• (1) eyelid diseases - eyelid entropion, eyelid ectropion, eyelid, ptosis, and palpebral dyskinesia;
• (2) conjunctival diseases - pterygium and conjunctivitis;
• (3) history of ocular surface chemical injury or use of eye drops with moisturizing artificial tears;
• (4) history of eye surgery within 6 months or history of retinal laser photocoagulation;
• (5) systemic diseases - Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave 's disease, systemic lupus erythematosus, and others.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	Diabetes mellitus	Children and adolescents with diabetes mellitus

Primary Outcome Measures

Name	Time	Method
Diabetic eye diseases	January 1, 2028	Prevalence of eye diseases due to diabetes.

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention & Treatment Center; 🇨🇳 Shanghai, Shanghai, China