Feasibility and Effectiveness of Diabetic Retinopathy Screening Using Artificial Intelligence in Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Feasibility of AI for retinopathy screening
研究概览
简要总结
The proposed project is a clinical intervention trial testing the feasibility and effectiveness of diabetic retinopathy screening evaluated by artificial intelligence (AI) based software in children with type 1 diabetes (CwD). Another novel method, the confocal microscopy of the retina will be used to assess the early stages of diabetic neuropathy. In parallel, we aim to assess the prevalence of diabetic retinopathy and neuropathy in a well-controlled population of CwD at a tertiary diabetes care center.
Each participant will undergo an examination of diabetic retinopathy using the non-mydriatic fundus camera. The resulting photography will be evaluated by AI driven software. The participant will then follow this examinaton with fundus ophtalmoscopy in arteficial mydriasis as a standard method of diabetic retinopathy assessment. Another method, the optic coherence tomography (OCT), which is considered as the most sensitive method for diabetic retinopathy assessment, will be performed after that. The results of these methods will be compared to assess the sensitivity of each. The examination-satisfaction questionnaire will be given to the participants.
In subjects over 18 years, a confocal microscopy of the retina examination will be performed to assess the status of the corneal sub-basal nerve plexus and the presence of diabetic neuropathy will be noted.
The prevalence of diabetic retinopathy and neuropathy in this group of children with diabetes will be assessed based on the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes diagnosed according to the ADA criteria
- •Age over 11.0 years or duration of diabetes over 2 years
- •Signed written informed consent by both the CwD and their parent/caregiver
排除标准
- •Unwillingness to sign a written informed consent by both the CwD and their parent/caregiver
研究组 & 干预措施
Study arm
All participants will undergo 3 consecutive examinations - non-mydriatic fundus camera assessed by AI-driven software, fundus opthalmoscopy assessed by experienced opthalmologist and optic coherence tomography examination.
干预措施: Non-mydriatic fundus camera photography (Diagnostic Test)
Study arm
All participants will undergo 3 consecutive examinations - non-mydriatic fundus camera assessed by AI-driven software, fundus opthalmoscopy assessed by experienced opthalmologist and optic coherence tomography examination.
干预措施: Fundus ophtalmoscopy (Diagnostic Test)
Study arm
All participants will undergo 3 consecutive examinations - non-mydriatic fundus camera assessed by AI-driven software, fundus opthalmoscopy assessed by experienced opthalmologist and optic coherence tomography examination.
干预措施: Optic coherence tomography (Diagnostic Test)
Study arm
All participants will undergo 3 consecutive examinations - non-mydriatic fundus camera assessed by AI-driven software, fundus opthalmoscopy assessed by experienced opthalmologist and optic coherence tomography examination.
干预措施: Confocal microscopy of the retina (Diagnostic Test)
结局指标
主要结局
Feasibility of AI for retinopathy screening
时间窗: Through study completion, on average 6 months.
The primary objective of this study is to test whether performing the diabetic retinopathy screening using the non-mydriatic fundus camera with AI software is feasible. The exact outcome is the percent of participants who will agree to undergo the procedure and will obtain a valid result (either positive or negative).
次要结局
- Examination satisfaction(Through study completion, on average 6 months.)
- Prevalence of diabetic retinopathy(Through study completion, on average 6 months.)
- Prevalence of diabetic neuropathy(Through study completion, on average 6 months.)
研究者
Vit Neuman
MD, PhD
University Hospital, Motol