Shanghai Children and Adolescent Diabetes Eye Study (SCADE)

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.

Study Overview

• Status: Recruiting
• Conditions: Eye Diseases; Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: Diabetes mellitus

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Haidong Zou, post-doctor; Phone Number: 13311986528; Email: zouhaidong@263.net

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Shanghai Eye Disease Prevention & Treatment Center
      • Contact: Haidong Zou, Ph.D; Phone Number: 8613311986528; Email: zouhaidong@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From January 2018 to 2028, children who are diagnosed with diabetes at the Children's Hospital of Fudan University in Shanghai, will be recruited as cases of diabetes. We will also recruit children without diabetes, who will be matched for age and gender, from this hospital as controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; Children and adolescents with diabetes mellitus	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.
Control group; Children and adolescents without diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetic eye diseases	Prevalence of eye diseases due to diabetes.	January 1, 2028

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Collaborators: Children's Hospital of Fudan University
• Investigators: Study Chair: Haidong Zou, MD,PhD, Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): January 1, 2028
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Eye Diseases
• Other Study ID Numbers: 2018004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No