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Shanghai Children and Adolescent Diabetes Eye Study

Shanghai Children and Adolescent Diabetes Eye Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03587948
Acronym
SCADE
Enrollment
600
Registered
2018-07-16
Start date
2018-01-01
Completion date
2028-01-01
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Eye Diseases

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.

Interventions

DIAGNOSTIC_TESTDiabetes mellitus

Children and adolescents who is diagnosed with diabetes will be involved in case-group, and others will be involved in control-group.

Sponsors

Children's Hospital of Fudan University
CollaboratorOTHER
Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diabetic eye diseasesJanuary 1, 2028Prevalence of eye diseases due to diabetes.

Countries

China

Contacts

Primary ContactHaidong Zou, post-doctor
zouhaidong@263.net13311986528

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026