Diagnosis of ON With or Without MS or NMOSD

NCT04131764 | Terminated FDA Device

• 1 other identifier: 53342
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

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)

ON and multiple sclerosis

Patients who have a diagnosis of optic neuritis AND multiple sclerosis.

Diagnostic Test: Reflex (Brightlamp Inc., Purdue University)

ON and NMOSD

Patients who have a diagnosis of optic neuritis and neuromyelitis optica spectrum disorder.

Diagnostic Test: Reflex (Brightlamp Inc., Purdue University)

Interventions

Reflex (Brightlamp Inc., Purdue University) 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; ON and multiple sclerosis; Optic neuritis diagnosis only

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagannadha R Avasarala: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Links

• Reflex User Guide

MeSH Terms

Conditions

Multiple Sclerosis; Optic Neuritis; Neuromyelitis Optica

Interventions

Reflex

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Myelitis, Transverse

Intervention Hierarchy (Ancestors)

Neurologic Examination; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jagannadha Avasarala, MD PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 18, 2019
• Study Start: October 4, 2019
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)