How Does the visuALL Field Analyzer (vFA) Compare to Standard Automatic Perimetry (SAP) in Patients With Mild and Moderate Chronic Open Angle Glaucoma (COAG) and Subjects Without Eye Problems?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Mean Retinal Sensitivity From Two Machines
研究概览
简要总结
To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP).
详细描述
Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. The current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc.
Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient comfort.
The main goal of this study is to evaluate the repeatability of a novel psychophysical platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities. Other objectives of this study include the development of an initial reference database and comparison of the measured parameters with HFA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21 to 80 years
- •Healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (SAP).
- •mild glaucoma subjects with less than -6 mean deviation
- •moderate glaucoma subjects with -6 to -12 mean deviation
排除标准
- •spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters
- •Unreliable SAP (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts)
- •Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive fixation losses)
- •SAP abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma
- •Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification)
- •History of systemic condition known to affect visual function
- •History of medication known to affect visual function
结局指标
主要结局
Mean Retinal Sensitivity From Two Machines
时间窗: three hours
Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.
Global Correlation (Agreement Between Two Machines in the Overall Visual Field)
时间窗: three hours
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.
次要结局
- Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)(three hours)
- Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field(three hours)
研究者
M. Reza Razeghinejad MD
Principal Investigator
Wills Eye