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Diagnosis of ON With or Without MS or NMOSD

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ClinicalTrials.gov Identifier: NCT04131764
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jagannadha R Avasarala, University of Kentucky

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 (patientor 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Neuromyelitis Optica Spectrum Disorder Attack Neuromyelitis Optica Spectrum Disorder Relapse Neuromyelitis Optica Spectrum Disorder Progression Optic Neuritis 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 your 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, we will compare the results of your app recording to other data that has been collected which also tracks optic nerve function status.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: 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
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022


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.




Primary Outcome Measures :
  1. Feasability [ Time Frame: 10 seconds ]
    Feasibility of using quantified pupillary responses as a surrogate marker for assessment of optic nerve dysfunction in ON, MS, and NMOSD.

  2. Comparative data assessment [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 80 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131764


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
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Principal Investigator: Jagannadha Avasarala, MD PhD University of Kentucky

Additional Information:
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Responsible Party: Jagannadha R Avasarala, Professor of Neurology, University of Kentucky
ClinicalTrials.gov Identifier: NCT04131764     History of Changes
Other Study ID Numbers: 53342
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jagannadha R Avasarala, University of Kentucky:
multiple sclerosis
MS
Neuromyelitis optica spectrum disorder
NMOSD
optic neuritis
pupillary response
RAPD
rapid afferent pupillary defect
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuritis
Optic Neuritis
Neuromyelitis Optica
Disease
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Myelitis, Transverse