Shanghai Children and Adolescent Diabetes Eye Study

NCT ID: NCT03587948

Last Updated: 2018-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2028-01-01

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Eye Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group

Children and adolescents with diabetes mellitus

Diabetes mellitus

Intervention Type DIAGNOSTIC_TEST

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

No interventions assigned to this group

Interventions

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Diabetes mellitus

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role collaborator

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haidong Zou, MD,PhD

Role: STUDY_CHAIR

Shanghai Eye Disease Prevention and Treatment Center

Locations

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Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haidong Zou, post-doctor

Role: CONTACT

13311986528

Facility Contacts

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Haidong Zou, Ph.D

Role: primary

8613311986528

Other Identifiers

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2018004

Identifier Type: -

Identifier Source: org_study_id

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