Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
研究概览
简要总结
The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female
- •Between 18 and 80 years of age
- •Either eye, but only one eye per subject will be enrolled
- •Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
排除标准
- •Any known ocular disease
- •Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.
- •Topcon image quality factor ≤ 44 or Stratus signal strength <
- •Retinal Disease
- •Inclusion Criteria:
- •Male or female
- •Between 18 and 80 years of age
- •Either eye, but only one eye per subject will be enrolled
- •Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study
- •A range of retinal thickness will be included
- •Topcon image quality factor ≥ 45 or Stratus signal strength ≥
- •Exclusion Criteria:
- •Presence of glaucoma
- •Topcon image quality factor ≤ 44 or Stratus signal strength < 5.
结局指标
主要结局
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
时间窗: 30 Minutes
The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer
次要结局
未报告次要终点