Shanghai Children and Adolescent Diabetes Eye Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-18
SponsorShanghai Eye Disease Prevention and Treatment Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(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.
Disqualifiers
(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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Diabetes mellitus
Diagnostic testChildren and adolescents who is diagnosed with diabetes will be involved in case-group, and others will be involved in control-group.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Case group1 intervention
Group B: Control group0 interventions
Trial outcomes
Primary outcomes
1
Diabetic eye diseases
Prevalence of eye diseases due to diabetes.
Time frame
January 1, 2028Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Eye Disease Prevention and Treatment Center
Lead sponsor
Children's Hospital of Fudan University
Collaborator
Source ClinicalTrials.gov