NCT04499703已完成不适用
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema
Kubota Vision Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年11月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the RHMS-RTM retinal thickness measurements
研究概览
简要总结
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
详细描述
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
- •Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
- •Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- •Able and willing to provide written informed consent before undergoing any study-related procedures
- •Group 1: Macula with normal thickness [central subfield thickness (CST): <305μm in women, and <320μm in men as measured by Heidelberg Spectralis SD-OCT in at least one eye. Patients diagnosed with dry AMD are eligible for enrollment into Group
- •No history of wAMD, DR, or RVO in either eye
- •Group 2 and Group 3, in at least one and the same eye: History of center-involving macular edema due to wAMD (Group 2); or DR or RVO (Group 3); Macular edema on SD-OCT with CST ≥305 μm in women, and ≥320μm in men as measured by Heidelberg Spectralis SD-OCT.
排除标准
- •History of corneal refractive surgery [e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)] in the study eye(s)
- •History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
- •Participation in any study using an investigational drug within 30 days of screening or an investigational device within 60 days of screening
- •Refractive error within defined limits
- •History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)
结局指标
主要结局
Evaluation of the RHMS-RTM retinal thickness measurements
时间窗: 1 day
To evaluate the ability of the RHMS-RTM device to measure retinal thickness
次要结局
- Repeatability of RHMS-RTM retina thickness measurements(1 day)
- Intraretinal and subretinal fluid detection(1 day)
- Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT(1 day)
研究者
研究点 (1)
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