Diagnosis of ON With or Without MS or NMOSD

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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis; Optic Neuritis; Neuromyelitis Optica Spectrum Disorder Attack; Neuromyelitis Optica Spectrum Disorder Relapse; Neuromyelitis Optica Spectrum Disorder Progression
• Intervention / Treatment: Diagnostic test: Reflex (Brightlamp Inc., Purdue University)

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Optic neuritis diagnosis only; Patients who have a diagnosis of optic neuritis, without a diagnosis of MS or NMOSD.	Diagnostic test: Reflex (Brightlamp Inc., Purdue University); The Reflex pupillometer is a mobile based application that provides a quantitative way to monitor pupillary activity and responsiveness. It uses the mobile phone as a source of light and records pupillary response, as well as analyzes and compiles the data. It produces quantitative measures such as latency, minimum and maximum pupil diameter, maximum and average constriction velocity, dilation velocity, and 75% recovery time.
ON and multiple sclerosis; Patients who have a diagnosis of optic neuritis AND multiple sclerosis.	Diagnostic test: Reflex (Brightlamp Inc., Purdue University); The Reflex pupillometer is a mobile based application that provides a quantitative way to monitor pupillary activity and responsiveness. It uses the mobile phone as a source of light and records pupillary response, as well as analyzes and compiles the data. It produces quantitative measures such as latency, minimum and maximum pupil diameter, maximum and average constriction velocity, dilation velocity, and 75% recovery time.
ON and NMOSD; Patients who have a diagnosis of optic neuritis and neuromyelitis optica spectrum disorder.	Diagnostic test: Reflex (Brightlamp Inc., Purdue University); The Reflex pupillometer is a mobile based application that provides a quantitative way to monitor pupillary activity and responsiveness. It uses the mobile phone as a source of light and records pupillary response, as well as analyzes and compiles the data. It produces quantitative measures such as latency, minimum and maximum pupil diameter, maximum and average constriction velocity, dilation velocity, and 75% recovery time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of device for diagnosis of ON	Feasibility of using quantified pupillary responses as a surrogate marker for assessment of optic nerve dysfunction in ON, MS, and NMOSD.	10 seconds
Comparative data assessment	Comparing Reflex with other routine clinical methods of evaluating optic nerve dysfunction	Time of app scan (10s) plus time to compare data (1-2 hours)

Collaborators and Investigators

• Sponsor: Jagannadha R Avasarala

Publications and helpful links

Helpful Links

• Reflex website
• Reflex User Guide

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2019
• Primary Completion (ACTUAL): September 6, 2022
• Study Completion (ACTUAL): September 6, 2022

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (ACTUAL): October 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: MS; multiple sclerosis; Neuromyelitis optica spectrum disorder; optic neuritis; NMOSD; pupillary response; RAPD; rapid afferent pupillary defect
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Multiple Sclerosis; Sclerosis; Disease; Neuritis; Optic Neuritis; Neuromyelitis Optica
• Other Study ID Numbers: 53342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No