Diagnosis of ON With or Without MS or NMOSD

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04131764
• Other study ID #: 53342
• Status: Terminated
• Start date: October 4, 2019
• Est. completion date: September 6, 2022

Study information

• Verified date: November 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Multiple Sclerosis
• Neuritis
• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder Attack
• Neuromyelitis Optica Spectrum Disorder Progression
• Neuromyelitis Optica Spectrum Disorder Relapse
• Optic Neuritis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Jagannadha R Avasarala

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)

External Links

•   Reflex User Guide
•   Reflex website