Diagnosis of ON With or Without MS or NMOSD

NCT ID: NCT04131764

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2022-09-06

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.

Conditions

Multiple Sclerosis; Neuromyelitis Optica Spectrum Disorder Attack; Neuromyelitis Optica Spectrum Disorder Relapse; Neuromyelitis Optica Spectrum Disorder Progression; Optic Neuritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Optic neuritis diagnosis only

Patients who have a diagnosis of optic neuritis, without a diagnosis of MS or NMOSD.

Reflex (Brightlamp Inc., Purdue University)

Intervention Type: DIAGNOSTIC_TEST

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.

Reflex (Brightlamp Inc., Purdue University)

Intervention Type: DIAGNOSTIC_TEST

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.

Reflex (Brightlamp Inc., Purdue University)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagannadha R Avasarala

OTHER

Sponsor Role: lead

Responsible Party

Jagannadha R Avasarala

Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jagannadha Avasarala, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Related Links

https://static1.squarespace.com/static/5c269669297114a6e7a6cf31/t/5c658ae0652dea8b1f6b4b72/1550158561852/Reflex+User+Guide.pdf

Reflex User Guide

Other Identifiers

53342

Identifier Type: -

Identifier Source: org_study_id