NOVA™ PERG (Pattern Electroretinogram)and FERG (Flash Electroretinogram): Establishment of Reference Values for PERG and FERG Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude
研究概览
简要总结
The main goal of the study is to compile a normative database for the Neuro Optic Vision Assessment (NOVATM) Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules. This normalization intends to be included in a probabilistic analysis protocol to allow NOVATM PERG/FERG users to identify patients with results outside the normal ranges.
详细描述
Investigators plan to enroll 50 subjects at Wills Eye Hospital without any eye diseases.
Participants will undergo a complete eye examination to determine eligibility, including visual acuity testing, intraocular pressure (IOP) in millimeters of mercury (mmHG), and visual field (VF) testing.
Participants will then be tested with Diopsys NOVA™ PERG & FERG systems. For both tests, two electrodes are placed on the skin underneath each eye below the eyelashes. Participants' skin will be cleaned before electrodes are placed. A small amount of gel will be placed on skin where electrodes are placed for testing. Electrical responses are recorded with electrodes in response to visual stimuli.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers age 18 years
- •older with normal eye exam
排除标准
- •spherical refraction outside + 5.0 Diopters and cylinder correction outside + 3.0 Diopters.
- •IOP (intraocular pressure) ≥ 22 mm Hg (millimeters of mercury)
- •history of any type of glaucoma in either eye.
- •Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment).
- •Best corrected visual acuity worse than 20/
- •Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye.
- •Evidence of optic nerve, macula and/or retinal nerve fiber layer abnormality in either eye.
- •Evidence of reproducible (false positives, fixation losses and false negatives ≤ 25% with no observable testing artifacts).
- •Standard Automatic Perimetry (SAP) abnormality in either eye, defined as Pattern Standard Deviation < 5% level, and/or abnormal Glaucoma Hemifield test result, and/or any other pattern of loss which is consistent with a neurologic and/or ocular disease.
- •Current or recent (within the past 30 days) use of an agent (by any administering method) known to affect visual function.
- •Inability to obtain reliable PERG/FERG (Pattern Electroretinogram/Flash Electroretinogram) results.
研究组 & 干预措施
Healthy Controls
Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.
干预措施: Diopsys NOVA (Diagnostic Test)
结局指标
主要结局
Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude
时间窗: 2 hours
Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts.
Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency
时间窗: 2 hours
Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) latency in milliseconds.
次要结局
未报告次要终点
研究者
L. Jay Katz MD
Glaucoma Specialist
Wills Eye