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Diagnosis of ON With or Without MS or NMOSD

NCT04131764 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2022-11-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Jagannadha R Avasarala

    lead OTHER

Principal Investigators

  • Jagannadha Avasarala, MD PhD · University of Kentucky

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2022-09-06
Completion
2022-09-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04131764 on ClinicalTrials.gov