Shanghai Children and Adolescent Diabetes Eye Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diabetes mellitus.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Eye Diseases. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test Diabetes mellitus
Children and adolescents who is diagnosed with diabetes will be involved in case-group, and others will be involved in control-group.
Primary outcome measures
- Diabetic eye diseases [Time frame: January 1, 2028]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Eye Disease Prevention & Treatment Center — Shanghai
Identifiers
NCT: NCT03587948 · 2018004