NCT04428242撤回不适用
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 个国家开始时间: 2020年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 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
- 18 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 20/100 or better, in the study eye(s)
- •Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
- •Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- •Able and willing to give informed consent
- •Macula with normal thickness [central subfield thickness (CST) below 305 microns as measured by SD-OCT] in at least one eye
- •Patients with dry AMD are eligible for enrollment into Group 1
- •No history of wet AMD, DR, or RVO in either eye
- •Group 2 and Group 3 (in at least one or the same eye):
- •History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO (Group 3)
- •Macular edema on SD-OCT with CST ≥ 305 microns
排除标准
- •History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye
- •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 or screening or investigational device within 60 days of screening
- •Refractive error: spherical equivalent of > 3 diopters of hyperopia or > 6 diopters of myopia, or > 2 diopters cylinder in the study eye(s)
- •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
RHMS-RTM repeatability
时间窗: 1 day
To assess repeatability of the RHMS-RTM device
Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT
时间窗: 1 month
To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT
次要结局
未报告次要终点
研究者
研究点 (1)
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