跳至主要内容
临床试验/NCT04131764
NCT04131764终止不适用

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

Jagannadha R Avasarala1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年10月4日最近更新:
适应症

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

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

发起方
Jagannadha R Avasarala
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jagannadha R Avasarala

Professor of Neurology

University of Kentucky

研究点 (1)

Loading locations...

相似试验