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Shanghai Children and Adolescent Diabetes Eye Study (SCADE)

S

Shanghai Eye Disease Prevention and Treatment Center

Status

Enrolling

Conditions

Diabetes Mellitus
Eye Diseases

Treatments

Diagnostic Test: Diabetes mellitus

Study type

Observational

Funder types

Other

Identifiers

NCT03587948
2018004

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

600 participants in 2 patient groups

Case group
Description:
Children and adolescents with diabetes mellitus
Treatment:
Diagnostic Test: Diabetes mellitus
Control group
Description:
Children and adolescents without diabetes mellitus

Trial contacts and locations

1

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Central trial contact

Haidong Zou, post-doctor

Data sourced from clinicaltrials.gov

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