Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03587948

Shanghai Children and Adolescent Diabetes Eye Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Haidong Zou, Ph.D

CONTACT

[email protected]

8613311986528

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes mellitus

Diagnostic Test

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

Primary outcomes

  1. Diabetic eye diseases

    Time frame: January 1, 2028

    Prevalence of eye diseases due to diabetes.

Study contacts

Contact information is provided by the study sponsor or research team.

Haidong Zou, post-doctor

CONTACT

[email protected]

13311986528

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Collaborators

  • Children's Hospital of Fudan University

Registry information

Acronym: SCADE

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.