NCT01228721终止4 期
Reproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 试验地点
- 1
- 主要终点
- retinal nerve fiber layer thickness measurement
研究概览
简要总结
PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma patients and healthy control subjects using Spectralis® SD-OCT.
METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator within one session with a brief rest between measurements. Three measurements were taken with the eye-tracker and retest function, and three were taken without this function, alternating between measurement methods.
- Trial with medical device
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual acuity of more or equal to 0.5 Snellen, refractive error less than ±5.00 diopters (D) spheric and ±3.00 D cylindrical and no history of ocular trauma or of any other severe ocular disease (particularly diseases affecting the optic nerve or surgery other than uncomplicated cataract surgery).
- •Additional inclusion criteria for the glaucoma group were a diagnosis of primary open angle glaucoma (POAG) or PEX-glaucoma.
排除标准
- •Exclusion criteria for the control group were history of glaucoma or intraocular pressure beyond 21 mmHg and optic disc cupping of more than 0.6
结局指标
主要结局
retinal nerve fiber layer thickness measurement
次要结局
未报告次要终点
研究者
研究点 (1)
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