Comparing eye disease prevalence in diabetic and healthy children
Shanghai Children and Adolescent Diabetes Eye Study
This study looks at how common eye diseases are in children with diabetes compared to healthy kids to help improve eye care for those with diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Shanghai Eye Disease Prevention and Treatment Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT03587948 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to compare the prevalence of eye diseases between children and adolescents diagnosed with diabetes mellitus and a control group of healthy children. Conducted at the Children's Hospital of Fudan University in Shanghai from 2018 to 2028, the study will enroll 300 diabetic children and 300 healthy children. The research will analyze factors related to eye diseases in diabetic patients to improve screening and management of diabetic eye health. The ultimate goal is to reduce the rates of diabetic eye disease and enhance awareness of eye health among diabetic youth.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 18 years who have been diagnosed with type 1 or type 2 diabetes.
Not a fit: Patients with specific ocular conditions or systemic diseases that could affect eye health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management of eye health in children with diabetes, potentially reducing the incidence of blindness and visual impairment.
How similar studies have performed: Other studies have shown success in understanding the relationship between diabetes and eye diseases, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Eye Disease Prevention & Treatment Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Haidong Zou, post-doctor
- Email: zouhaidong@263.net
- Phone: 13311986528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.