NIDEK Gonioscope GS-1 for Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Inter-Observer Repeatability for NIDEK Gonioscope GS-1
研究概览
简要总结
The Gonioscope GS-1 is an ophthalmic camera with gonioscopic prism that is intended to capture, display and store images of the anterior chamber angle and its peripheral part. This study evaluates the efficiency of Gonioscope GS-1 in glaucoma patients.With the captured images, the glaucoma diagnosis and post-operative observation are enabled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with glaucoma or glaucoma suspect
- •Glaucoma Suspect
- •Glaucomatous optic neuropathy as described in the glaucoma patients below
- •AND/OR ocular hypertension (IOP > 21 mm Hg)
- •Normal visual field
- •Glaucoma Patients
- •Clinical characteristics of glaucoma: ONH abnormalities: global rim thinning, rim notch, or disc hemorrhage; RNFL defect
- •Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.
- •Both eyes will be included, except in cases where only one eye meets study criteria
排除标准
- •Corneal opacities (scars, edema, etc.)
- •Pregnant or planning to become pregnant
- •Inability to fixate gaze
结局指标
主要结局
Inter-Observer Repeatability for NIDEK Gonioscope GS-1
时间窗: 1 Day
To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.
Inter-Observer Repeatability for Standard Digital Gonioscopic images
时间窗: 1 Day
To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.
次要结局
未报告次要终点