Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eyenuk, Inc.
- 入组人数
- 942
- 试验地点
- 1
- 主要终点
- Number of subject eyes whose EyeArt results match the reading center grading for identifying vision threatening diabetic eye disease (severe NPDR or PDR or surrogate markers for CSME).
研究概览
简要总结
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF treatment if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary.
EyeArt is an automated screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DED. This study is designed to assess the safety and efficacy of EyeArt.
详细描述
This is a prospective, multi-center, observational study to assess the safety and efficacy of EyeArt in screening for DR.
This study will enroll up to 940 subjects who meet the eligibility criteria at eye care practices and primary/diabetes care practices. Subjects will undergo fundus photography per the EyeArt photography manual using commercially available, Food and Drug Administration (FDA) cleared, non-mydriatic fundus cameras.
Additionally, after dilation, the subject will undergo clinical reference standard photography by photographers certified to obtain photographs for clinical reference standard grading.
The EyeArt screening results on photographs obtained per the EyeArt photography manual will be compared with the clinical reference standard grading to evaluate the sensitivity and specificity of the EyeArt device.
The study will be conducted in accordance with applicable regulatory requirements and established rules for Good Clinical Practice (GCP). Study sites will be chosen to meet the study requirements.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of diabetes mellitus;
- •Understanding of study and provision of written informed consent; and
- •18 years of age or older.
排除标准
- •Persistent visual impairment in one or both eyes;
- •History of macular edema or retinal vascular (vein or artery) occlusion;
- •History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
- •Subject is contraindicated for fundus photography (for example, has light sensitivity);
- •Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
- •Subject is currently enrolled in an interventional study of an investigational device or drug; or
- •Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs.
结局指标
主要结局
Number of subject eyes whose EyeArt results match the reading center grading for identifying vision threatening diabetic eye disease (severe NPDR or PDR or surrogate markers for CSME).
时间窗: 1 visit (1 day)
The performance of EyeArt will be evaluated using sensitivity and specificity measures.
Number of subject eyes whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
时间窗: 1 visit (1 day)
The performance of EyeArt will be evaluated using sensitivity and specificity measures.
次要结局
未报告次要终点