An observational study in Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder Attack and Neuromyelitis Optica Spectrum Disorder Relapse, sponsored by Jagannadha R Avasarala. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by Jagannadha R Avasarala · Observational
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.
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 112 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Jagannadha R Avasarala is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have a diagnosis of optic neuritis, without a diagnosis of MS or NMOSD.
Diagnostic Test: Reflex (Brightlamp Inc., Purdue University)
Patients who have a diagnosis of optic neuritis AND multiple sclerosis.
Diagnostic Test: Reflex (Brightlamp Inc., Purdue University)
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.
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.
Time frame: 10 seconds
Comparative data assessment
Comparing Reflex with other routine clinical methods of evaluating optic nerve dysfunction
Time frame: Time of app scan (10s) plus time to compare data (1-2 hours)
Plan to share: No
Ran from Oct 2019 to primary completion in Sep 2022, 35 months.
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This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Jagannadha R Avasarala