NCT04905459已完成不适用
A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,012
- 试验地点
- 13
- 主要终点
- Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images
研究概览
简要总结
This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Type I or Type II diabetes mellitus:
- •meet the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
- •Age 22 or older
- •Understand the study and volunteer to sign the informed consent
排除标准
- •Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
- •Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.
- •History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- •Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
- •Currently participating in an interventional study.
- •Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation, etc.).
- •Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.
- •Participant is hypersensitive to light (side effect of medication or due to unknown etiology)
- •Participant has undergone photodynamic therapy (PDT)
- •Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).
- •Known pregnancy or possibility of pregnancy
结局指标
主要结局
Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images
时间窗: 1 day
Specificity of ARDA mtmDR for detection of mtmDR in UWF images
时间窗: 1 day
Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images
时间窗: 1 day
Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (13)
Loading locations...
相似试验
已完成
不适用
MatErnal BLood IS Source to Accurately Diagnose Fetal AneuploidyPregnant WomenPrenatal CareNCT01122524Verinata Health, Inc.10,000
已完成
不适用
Lamictal Bipolar Observational StudyBipolar DisorderNCT00460226GlaxoSmithKline238
已完成
不适用
A Multicentre Clinical Investigation to Assess Efficacy and Safety of Intra-articular Injections of Hyaluronic Acid Combined With Chondroitin Sulfate in Knee OsteoarthritisOsteo Arthritis KneeNCT04358120Fidia Farmaceutici s.p.a.74
Unknown
不适用
Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid ArthritisRheumatoid ArthritisNCT05240859Peking University People's Hospital1,600
尚未招募
不适用
Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.Syphilis InfectionNCT06584214Abbott Rapid Dx400