Clinical trial NCT04131764: Diagnosis of ON With or Without MS or NMOSD
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Neuromyelitis Optica Spectrum Disorder Attack
Neuromyelitis Optica Spectrum Disorder Relapse
Neuromyelitis Optica Spectrum Disorder Progression
Optic Neuritis
Keywords: multiple sclerosis
MS
Neuromyelitis optica spectrum disorder
NMOSD
optic neuritis
pupillary response
RAPD
rapid afferent pupillary defect
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients include those seen at the University of Kentucky during routine clinical neurology visits between the ages of 18 and 90 years who have been diagnosed with optic neuritis, optic neuritis and multiple sclerosis, or optic neuritis and neuromyelitis optica spectrum disorder and have had at least one previous test that tracks optic nerve function.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients ages 18-90 years
2. Signed informed consent
3. Have been diagnosed with optic neuritis (ON) only, MS and ON, or NMOSD and ON
4. Have had at least one previous test to track optical nerve function

Exclusion Criteria:

1. Are pregnant or nursing
2. Are children (age \<18 years)
3. Do not have a diagnosis of optic neuritis (ON)
4. Have a diagnosis of MS or NMOSD without a diagnosis of ON as well

Primary outcomes:
measure: Feasibility of device for diagnosis of ON
timeFrame: 10 seconds
measure: Comparative data assessment
timeFrame: Time of app scan (10s) plus time to compare data (1-2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jagannadha Avasarala, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: