Multiple SclerosisNCT04131764
Diagnosis of ON With or Without MS or NMOSD
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder Attack, run by Jagannadha R Avasarala at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder Attack, Neuromyelitis Optica Spectrum Disorder Relapse
- What is being tested?
- Reflex (Brightlamp Inc., Purdue University)
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2019to 6 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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.
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder Attack, Neuromyelitis Optica Spectrum Disorder Relapse, Neuromyelitis Optica Spectrum Disorder Progression, Optic Neuritis
- Being tested
- Reflex (Brightlamp Inc., Purdue University)
- Keywords
- multiple sclerosis, MS, Neuromyelitis optica spectrum disorder, NMOSD, optic neuritis, pupillary response, RAPD, rapid afferent pupillary defect
- Medical subject headings
- Multiple Sclerosis, Optic Neuritis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Optic neuritis diagnosis only | Patients who have a diagnosis of optic neuritis, without a diagnosis of MS or NMOSD. Receives: Diagnostic Test: Reflex (Brightlamp Inc., Purdue University) | |
| ON and multiple sclerosis | Patients who have a diagnosis of optic neuritis AND multiple sclerosis. Receives: Diagnostic Test: Reflex (Brightlamp Inc., Purdue University) | |
| ON and NMOSD | Patients who have a diagnosis of optic neuritis and neuromyelitis optica spectrum disorder. Receives: Diagnostic Test: Reflex (Brightlamp Inc., Purdue University) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 seconds
Comparative data assessment
Comparing Reflex with other routine clinical methods of evaluating optic nerve dysfunction
Measured: Time of app scan (10s) plus time to compare data (1-2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start4 Oct 2019
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Why it stopped: IRB closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagannadha R Avasarala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jagannadha R Avasarala, University of Kentucky
- Investigators
- Jagannadha Avasarala, MD PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131764
- Sponsor's protocol ID
- 53342
- Status last verified
- Nov 2022
- First submitted
- 17 Oct 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04131764
- Acronym / sponsor ID
- 53342
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB closed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Jagannadha R AvasaralaUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Optic neuritis diagnosis only | – | Diagnostic Test: Reflex (Brightlamp Inc., Purdue University)Patients who have a diagnosis of optic neuritis, without a diagnosis of MS or NMOSD. |
| ON and multiple sclerosis | – | Diagnostic Test: Reflex (Brightlamp Inc., Purdue University)Patients who have a diagnosis of optic neuritis AND multiple sclerosis. |
| ON and NMOSD | – | Diagnostic Test: Reflex (Brightlamp Inc., Purdue University)Patients who have a diagnosis of optic neuritis and neuromyelitis optica spectrum disorder. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | ON and NMOSD, ON and multiple sclerosis, Optic neuritis diagnosis only |
Primary outcome
Feasibility of device for diagnosis of ON
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.
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
Results and safety
The study was stopped early (reason given: IRB closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Reflex User GuideLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jagannadha Avasarala, MD PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder Attack, run by Jagannadha R Avasarala at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IRB closed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of device for diagnosis of ON (time frame: 10 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.