NCT07378891Enrolling By Invitation不适用
Künstliche Intelligenz (KI)-gestützte Früherkennung Der Diabetischen Retinopathie (FUNDUS-KI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of retinal changes
研究概览
简要总结
Examination of individuals with prediabetes and established diabetes for early signs of diabetic retinopathy.
详细描述
Fundus images are acquired and analyzed using an AI algorithm. The fundus images are captured using two devices: a stationary fundus camera (CenterVue DRSplus) and the Optomed Aurora IQ handheld fundus camera. Retinal images are examined using AI-based image analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary adults
- •Aged between 18 and 80 years
- •Understanding of the study explanations and instructions
- •Prediabetes (defined by elevated fasting glucose 100-125 mg/dL and/or 2-hour glucose in the oral glucose tolerance test of 140-199 mg/dL and/or HbA1c of 5.7-6.4%)
- •manifest diabetes (all types of diabetes according to Ahlqvist)
排除标准
- •participants unable to give consent
- •Those who do not agree to be informed about incidentally detected pathological findings
- •Uncontrolled arterial hypertension (Stage III) despite multiple antihypertensive medications
- •Eye diseases that impair the interpretability of the fundus examination
研究组 & 干预措施
Prediabetes and Diabetes
Participants with prediabetes and diabetes
结局指标
主要结局
Assessment of retinal changes
时间窗: Day 1
Assessment of retinal changes in individuals with prediabetes and diabetes, quantified using an AI algorithm.
次要结局
- Image quality and comparison of the fundus cameras(Day 1)
- Influence of clinical parameters on retinal vascular changes(Day 1)
- Association of medications with the ocular fundus(Day 1)
研究者
研究点 (1)
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