An Objective Study to Compare the Diopsys NOVA and LKC RETeval Devices Using the Diopsys LID Electrodes and the LKC RETeval Self-Adhering Electrode Arrays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- PhNR Latency (ms)
研究概览
简要总结
To compare the Diopsys NOVA and LKC RETeval Devices using the Diopsys Lid Electrodes and LKC RETeval Self-Adhering Electrode Arrays.
详细描述
This study is an open label, prospective study comparing the Diopsys NOVA and LKC RETeval devices using the Diopsys Lid Electrodes and the LKC RETeval Self-Adhering Electrode Arrays.
Subjects will receive the PhNR test three times using the Diopsys device and Diopsys Electrodes. Next, subjects will receive the FL Flicker test three times using the Diopsys device and Diopsys Electrodes. There will be a short break (10 to 15 minutes), then subjects will receive the PhNR test three times using the Diopsys device with LKC Electrode Arrays, followed by the FL Flicker test three times using the Diopsys device with the LKC electrode arrays. Subjects will receive another short break (5 to 10 minutes), then receive the PhNR test three times using the LKC device with the LKC electrode arrays, followed by the FL Flicker test three times using the LKC device with the LKC electrode arrays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 22 years of age on day of enrollment
- •BCVA letter score of 75 or better (Snellen equivalent of 20/32 or better) on day of enrollment
- •Eyes are healthy/normal based on prior examinations, record review, and/or patient intake questions. Subject has not been diagnosed with any ocular pathology that could affect ERG results.
- •Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
- •Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines
排除标准
- •A spherical refraction outside + 5.0 D and cylinder correction outside + 3.0 D on day of enrollment
- •Intraocular surgery (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment)
- •Any prior macular or panretinal photocoagulation laser treatment
- •History of ophthalmic or neurologic condition known to affect visual function
- •Inability to obtain a reliable ERG test
- •History of Diabetic retinopathy
- •History of Glaucoma
- •History of ARMD
- •History of seizure disorder
- •Has an open sore(s) or dermatological condition that may come in contact with the electrodes/electrode arrays
- •In the opinion of the Investigator, is unlikely to comply with the study protocol
结局指标
主要结局
PhNR Latency (ms)
时间窗: Day 1
Change in ERG PhNR Latency (ms) parameter
次要结局
- FL Latency (ms)(Day 1)