Sensitivity and Specificity of the NOVA-DN VEP Protocol and a Novel Analysis of Optical Coherence Tomography Images for Glaucoma Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Visual Evoked Potential (VEP)
研究概览
简要总结
Evaluate sensitivity and specificity of NOVA-DN visually evoked potentials (VEP) protocol and new software method (Corda) for glaucoma detection using optical coherence tomography (OCT) images to differentiate between normal subjects and glaucoma suspects.
详细描述
The aim of this study was to evaluate the ability of NOVA-DN VEP protocol and Corda parameters to discriminate between healthy eyes and eyes with early to moderate glaucomatous visual field loss. We will evaluate measurements of the NOVA-DN VEP protocol, Corda software and Cirrus spectral domain (SD) OCT software in order to compare and correlate.
Hypotheses is that NOVA-DN VEP protocol and Corda analysis results in a high sensitivity, specificity and area under the Receiver Operating Characteristic (ROC) curves (ROC area) for glaucoma detection. Second hypothesis is NOVA-DN VEP protocol and Corda parameters can differentiate between normal and glaucoma suspects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Healthy Subjects
- •intraocular pressure less than 22 millimeters of mercury (mmHg)
- •normal appearing optic discs and retinal nerve fiber layer (RNFL)
- •normal optical coherence tomography (OCT) RNFL thickness
- •normal visual field (VF) results in both eyes.
- •Group 2: Glaucoma Suspects
- •glaucomatous appearance of optic discs and/or RNFL in at least one eye
- •normal OCT
- •normal VF results in both eyes.
- •Group3: Glaucoma Patients
- •Glaucomatous optic disc appearance (cup to disc ratio, rim thinning or RNFL defects)
- •Repeatable intraocular pressure (IOP) of 23 mmHg or more, in at least one eye
- •Repeatable abnormal VF tests
排除标准
- •inability to perform reliable VF or OCT
- •visual acuity worse than 20/40
- •refractive error greater than +/-5.00 diopters sphere, greater than +/- 3.00 diopers cylinder
研究组 & 干预措施
Healthy Subjects
42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal appearing optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual field results in both eyes. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
干预措施: Optical Coherence Tomography (Diagnostic Test)
Healthy Subjects
42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal appearing optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual field results in both eyes. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
干预措施: Visual evoked potential (Diagnostic Test)
Glaucoma Suspects
45 Glaucoma suspects with glaucomatous appearance optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology (RNFL thickness) and normal visual field results in both eyes. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
干预措施: Optical Coherence Tomography (Diagnostic Test)
Glaucoma Suspects
45 Glaucoma suspects with glaucomatous appearance optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology (RNFL thickness) and normal visual field results in both eyes. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
干预措施: Visual evoked potential (Diagnostic Test)
Glaucoma Patients
49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc appearance (those with cup to disc ratio greater than 0.7, rim thinning or Retinal Nerve Fiber Layer defects indicative of glaucoma) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
干预措施: Optical Coherence Tomography (Diagnostic Test)
Glaucoma Patients
49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc appearance (those with cup to disc ratio greater than 0.7, rim thinning or Retinal Nerve Fiber Layer defects indicative of glaucoma) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
干预措施: Visual evoked potential (Diagnostic Test)
结局指标
主要结局
Visual Evoked Potential (VEP)
时间窗: 1 examination, one hour
Diopsys Visual evoked potential (VEP) (Diopsys, Inc. Pine Brook, NJ) is used to objectively measure the functional responses of the entire visual pathway from the anterior segment of the eye to the visual cortex. This is the strength of the signal recorded from the back of the head near where vision is processed in the brain while a visual stimulus is presented to patient.
次要结局
- Retinal Nerve Fiber Layer Thickness(1 examination, one hour)
研究者
L. Jay Katz MD
Principal Investigator
Wills Eye