Diagnosis of ON With or Without MS or NMOSD

Terminated

• Conditions: Neuromyelitis Optica Spectrum Disorder Attack; Optic Neuritis; Multiple Sclerosis; Neuromyelitis Optica Spectrum Disorder Relapse; Neuromyelitis Optica Spectrum Disorder Progression
• Interventions: Diagnostic Test: Reflex (Brightlamp Inc., Purdue University)

• Registration Number: NCT04131764
• Lead Sponsor: Jagannadha R Avasarala

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.

Study Timeline

• Study Start: 2019-10-04
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-18
• Primary Completion: 2022-09-06
• Study Completion: 2022-09-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ON and multiple sclerosis	Reflex (Brightlamp Inc., Purdue University)	Patients who have a diagnosis of optic neuritis AND multiple sclerosis.
ON and NMOSD	Reflex (Brightlamp Inc., Purdue University)	Patients who have a diagnosis of optic neuritis and neuromyelitis optica spectrum disorder.
Optic neuritis diagnosis only	Reflex (Brightlamp Inc., Purdue University)	Patients who have a diagnosis of optic neuritis, without a diagnosis of MS or NMOSD.

Primary Outcome Measures

Name	Time	Method
Comparative data assessment	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	10 seconds	Feasibility of using quantified pupillary responses as a surrogate marker for assessment of optic nerve dysfunction in ON, MS, and NMOSD.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States