Shanghai Children and Adolescent Diabetes Eye Study

Diabetes Mellitus Clinical Trial

— SCADE  

Official title:

Shanghai Children and Adolescent Diabetes Eye Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03587948
• Other study ID #: 2018004
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 1, 2028

Study information

• Verified date: July 2018
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Haidong Zou, post-doctor
• Phone: 13311986528
• Email: zouhaidong[@]263.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Eye Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention & Treatment Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center	Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetic eye diseases	Prevalence of eye diseases due to diabetes.	January 1, 2028