NCT06879834招募中不适用
Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
The Filatov Institute of Eye Diseases and Tissue Therapy1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年11月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The accuracy
研究概览
简要总结
To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.
详细描述
Operator took fundus images with a non-mydriatic fundus camera as per the Retina-AI CheckEye imaging protocol (an optic disc centered image and a fovea centered image for each eye).Thereafter, operator uploaded fundus images in the AI system for processing by the neural network.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented diagnosis of diabetes mellitus by definition.
- •Understanding of the Study and willingness and ability to sign informed consent
- •Patient age 18 or above
- •Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes
排除标准
- •Patients under 18 years of age;
- •Failure to give informed consent;
- •Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.
- •A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.
结局指标
主要结局
The accuracy
时间窗: Baseline
The accuracy of detecting of DR
次要结局
- The percent of invalid images(Baseline)
- The percent of false positive detection of DR(Baseline)
研究者
Andrii Korol, MD, PhD
MD, PhD, DMedSc,Prof
The Filatov Institute of Eye Diseases and Tissue Therapy
研究点 (1)
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