Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eyenez LLC
- 入组人数
- 34
- 主要终点
- Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects
研究概览
简要总结
This prospective equivalency study compares the performance of two Ophthalmic Cameras, the Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained technicians will take pictures of the same patients' retinas and the quality of the photos will be evaluated. The study includes healthy patients and patients with a spectrum of retinal diseases. The study requires that technicians take pictures of the retinas of adult patients between 18 and 80 years of age using both the OC and OP. The pictures will be reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is equivalent to the OP, based on the quality of the images
详细描述
Subjects (patients) will be recruited via word of mouth.
The study duration will be approximately 1-2 weeks, assuming a recruitment rate of 15 subjects per week. The images will be recorded within 15 minutes and will involve minimal disruption to the clinical workflow.
In the Study Environment setting (Foothill Medical Offices), the User Interface will be evaluated by comparing retinal pictures taken with subject device OC and predicate device OP.
Patient subjects will be given an Information and Consent Form to complete prior to the study
The technicians employed by Foothill Eye Clinic will operate the device on patient participants by taking a retinal picture using OC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
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
- 是
入选标准
- •Written Informed Consent
- •Male or female
- •Age ≥ 18 years and ≤80 years
- •Normal Retina
- •Healthy subjects
排除标准
- •Limited Ability for Agreement
- •Spectrum of retinal diseases
- •Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit
- •Diseased subjects Inclusion Criteria:
- •Written Informed Consent
- •Male or female
- •Age ≥ 18 years and ≤80 years
- •Spectrum of retinal diseases
- •Diseased subjects Exclusion Criteria:
- •Normal Retina
- •Limited Ability for Agreement
- •Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit
结局指标
主要结局
Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects
时间窗: up to 1 week
At least 90% of retinal camera images from both retinal cameras will be equivalent
次要结局
未报告次要终点