Pivotal Trial to Assess the Clinical Performance of Ophthal-360
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Specificity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images
研究概览
简要总结
Multicenter, prospective, study to assess the performance of the Ophthal-360 platform in the diagnosis of more-than-mild Diabetic Retinopathy (mtmDR) in diabetic patients with no previous diagnosis of DR.
详细描述
This is a multicenter, prospective study in which 500 adult subjects at risk for DR but never before diagnosed who satisfy all entry criteria will be enrolled at up to 5 primary care sites.
An additional sub-study will be performed on 30 subjects to assess the precision of the algorithm in detecting DR by imaging these subjects multiple times to demonstrate intra- and inter-operator reliability of the algorithm.
All enrolled subjects will undergo retinal imaging by a novice operator with no experience using the fundus cameras listed. Images from each retinal imaging device will be saved to a computer and uploaded to the server for evaluation by the Ophthal-360 service. A report will be generated and archived for the results of each image.
After imaging by the novice operator, each patient will then have their eyes photographed by a professional fundus photographer using standard mydriatic and OCT imaging for macular edema evaluation. These images will be sent to a Fundus Photography Reading Center for final determination and diagnosis. Patients will received the result of the FPRC evaluation, but not be provided the reports generated by the software.
A comparison between the FPRC determination and the software generated report will be performed to evaluate the analytical performance of the algorithm.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Aged at least 22 years old.
- •A documented history of Diabetes Mellitus, defined as any of the following:
- •Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments
- •Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments
- •Oral Glucose Tolerance test with 2-hour plasma glucose ≥ 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
- •Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose ≥ 200mg/dL (11.1 mmol/L)
- •Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).
- •Willing to undergo fundus photography by up to 4 different methods and/or cameras.
- •Has signed a written informed consent form prior to study participation.
排除标准
- •Diagnosed with uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
- •Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
- •Has a positive history for laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- •Is currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).
- •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).
- •Is contraindicated for imaging by fundus imaging systems used in the study:
- •hypersensitive to light
- •recently (within 6 months) underwent photodynamic therapy (PDT)
- •taking medication that causes photosensitivity
- •positive history for angle-closure glaucoma or narrow anterior chamber angles
结局指标
主要结局
Specificity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images
时间窗: 1 day
Performance of the Ophthal-360 Software when compared to ground truth evaluation of fundus photographs by qualified experts.
Sensitivity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images
时间窗: 1 day
Performance of the Ophthal-360 Software when compared to results of evaluation of fundus photographs by qualified experts.
次要结局
未报告次要终点