USING ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- The accuracy
研究概览
简要总结
The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.
详细描述
The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.
This study is planned as a follow-up. Participants who meet the eligibility criteria will be recruited from sites staffed by the trained photographers. After assessing eligibility and securing written informed consent, fundus photographs will be captured using a nonmydriatic ocular fundus camera. Images will be taken according to a specific RAssbyAI Check Eye's imaging protocol provided to camera operator, and then analyzed by the RAssbyAI Check Eye's. The photography protocol consists of two images of the ocular fundus (one optic disc centered, one fovea centered).
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 as defined by:
- •A. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA) B. Hemoglobin A1c (HbA1c)>= 6.5% based on repeated assessments C. Fasting Plasma Glucose (FPG) >= 126 mg/dL (7.0 mmol/L) based on repeated assessments D. Oral Glucose Tolerance test with 2 hr plasma glucose >= 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
- •E. Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose >=200mg/dL (11.1 mmol/L).
- •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-Month 12
The accuracy of detecting of DR
次要结局
- The percent of invalid images(Baseline-Month 12)
- The percent of false positive detection of DR(Baseline-Month 12)
研究者
Andrii Korol, MD, PhD
MD, PhD, DMedSc
The Filatov Institute of Eye Diseases and Tissue Therapy