Shanghai Children and Adolescent Diabetes Eye Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Diabetic eye diseases
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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.
结局指标
主要结局
Diabetic eye diseases
时间窗: January 1, 2028
Prevalence of eye diseases due to diabetes.
次要结局
未报告次要终点