Utility of Quantification of Afferent Pupillary Defect in Predicting Optic Nerve Disease in Retrobulbar Neuritis, Multiple Sclerosis and Neuromyelitis Optica Spectrum Disease - a Retrospective and Prospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Comparative data assessment
研究概览
简要总结
This is both a prospective and retrospective study of patients with a known diagnosis of optic neuritis (ON) only, multiple sclerosis (MS) with ON, or neuromyelitis spectrum disorder (NMOSD) with ON. There will be no requirement for blinding (patient or assessor) and data collected with the Reflex app will be compared against other data that track optic nerve functional status, such as optical coherence tomography (OCT), visual fields (VF), low-contrast sensitivity, MRI orbits/brain and visual evoked potentials (VEP). Patients who have any diagnosis of ON, with or without a diagnosis of MS or NMOSD and who have had testing using other modalities such as VEPs, VF, low-contrast sensitivity studies, OCT, and MRI of brain or orbits will be included as retrospective subjects in the study. In this cohort, RAPD assessments will be completed and compared to against the data that has accrued as noted.
详细描述
The purpose of this research is to gather information on whether using quantitative- or numerical measurements of pupil changes as an alternative to qualitative- or observation based- testing can be done to assess optic nerve dysfunction in ON, MS with ON, and NMOSD with ON. One way this is done is through evaluating relative afferent pupillary defect (RAPD), which is a clinical sign that is used to detect an injury or defect in the pupil's pathway and this often involves the retina of the eye, which focuses light, and the optic nerve, which sends visual information to the brain. When shining a light into each eye, the eye with RAPD shows a slowed response to light, and when the light moves to the normal eye, the pupil of RAPD eye will dilate. Observational evaluations of RAPD are very common in clinical neurology to detect these optic nerve diseases. As technology has advanced, to lessen the observation errors, numerical measurement of RAPD is now possible through a web based app called Reflex (Brightlamp Inc., Purdue University), which is a FDAapproved class I regulated medical device. In this study, the investigator will compare the results of a participant's app recording to other data that has been collected which also tracks optic nerve function status.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- 否
入选标准
- •Male or female patients ages 18-90 years
- •Signed informed consent
- •Have been diagnosed with optic neuritis (ON) only, MS and ON, or NMOSD and ON
- •Have had at least one previous test to track optical nerve function
排除标准
- •Are pregnant or nursing
- •Are children (age <18 years)
- •Do not have a diagnosis of optic neuritis (ON)
- •Have a diagnosis of MS or NMOSD without a diagnosis of ON as well
结局指标
主要结局
Comparative data assessment
时间窗: Time of app scan (10s) plus time to compare data (1-2 hours)
Comparing Reflex with other routine clinical methods of evaluating optic nerve dysfunction
Feasibility of device for diagnosis of ON
时间窗: 10 seconds
Feasibility of using quantified pupillary responses as a surrogate marker for assessment of optic nerve dysfunction in ON, MS, and NMOSD.
次要结局
未报告次要终点
研究者
Jagannadha R Avasarala
Professor of Neurology
University of Kentucky
