Myasthenia GravisNCT06501794
Pilot Study: Use of the Saccadometer to Detect Characteristic Saccadic Peak Velocity in Myasthenia Gravis Patients
A study testing Quantitative measurement of eye movements in people with Myasthenia Gravis, run by University of Liverpool.
Trial summary
Fast eye movements have been shown to demonstrate characteristics that are specific to myasthenia gravis that are not present in other eye movement disorders. It is possible to measure these eye movements and potentially identify these characteristics using new portable eye movement testing equipment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Quantitative measurement of eye movements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient participants
- Confirmed diagnosis of Myasthenia Gravis by either a positive acetylcholine antibody serum test (AChR) and/or a positive single fibre electromyograph (SFEMG) test.
- Patient participants must have also had at least one episode of diplopia and/or eye movement abnormality attributed to their diagnosis of MG.
- Healthy participants:
- Must have no history of eye movement abnormality
- No have no history of other auto-immune disease (specifically diabetes, Thyroid Eye Disease and Chronic External Ophthalmoplegia).
Who cannot join
- Patients without confirmed Myasthenia Gravis diagnosis by means of either a positive AChR serum test and/or a positive SFEMG test.
- Patients with confirmed Myasthenia Gravis who have not had at least one episode of diplopia and or ptosis.
- Patients with current or previous episodes of ocular motility dysfunction that have a confirmed diagnosis other than Myasthenia Gravis.
- Any healthy participant found to have an abnormality of vision or eye movement upon screening or a history of auto-immune disease.
About this study
Fast eye movements have been shown to demonstrate characteristics that are specific to myasthenia gravis that are not present in other eye movement disorders. It is possible to measure these eye movements and potentially identify these characteristics using new portable eye movement testing equipment. The aim of this pilot study is to discover if these characteristics can be identified using portable eye movement testing equipment in patients with a confirmed diagnosis of myasthenia gravis.
Read the detailed description
The diagnosis of Myasthenia Gravis (MG) can be challenging, particularly in its ocular manifestation with current clinical procedures. Previous research has shown that fast eye movements in patients suffering with MG have quite specific characteristics that can be used to correctly diagnose the condition. The Saccadometer is a portable eye movement testing device that may provide the ability to detect the characteristics of fast eye movements that Myasthenia patients alone demonstrate - specifically these are hyperfast movements that are present when slower eye movements are impaired by the disease process. These fast movement characteristics are not present in defects of eye movements due to other aetiologies.
Saccadic properties of a small group of patients with a confirmed diagnosis of MG will be measured to identify if characteristic hyperfast saccades are present.
- Conditions
- Myasthenia Gravis
- Being tested
- Quantitative measurement of eye movements
- Keywords
- Saccades
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative measurement of eye movementsDevice
Saccadometer © - diagnostic device: non-invasive quantitative assessment of eye movement
| Study group | Role | What they receive |
|---|---|---|
| Myasthenia Gravis | Other | Participants with a confirmed diagnosis of Myasthenia Gravis Receives: Device: Quantitative measurement of eye movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saccadic Peak Velocity
Participants will be recruited, consented and tested at a single visit during their routine clinical visit, up to one year after being recruited. Quantitative assessment of their eye movements using the Saccadometer will be assessed at that point of contact and the outcome measure recorded.
Measured: Measured at first and only contact point within study i.e. day one and then not tested again
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study startMar 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Craig Murray, MRes, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501794
- Sponsor's protocol ID
- UoL001162
- Status last verified
- Jul 2024
- First submitted
- 26 Feb 2016
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Use of the Saccadometer to Detect Characteristic Saccadic Peak Velocity in Myasthenia Gravis Patients
- ClinicalTrials.gov ID
- NCT06501794
- Acronym / sponsor ID
- UoL001162
- Conditions
- Myasthenia Gravis
- Keywords
- Saccades
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Jul 2024 (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.
Fast eye movements have been shown to demonstrate characteristics that are specific to myasthenia gravis that are not present in other eye movement disorders. It is possible to measure these eye movements and potentially identify these characteristics using new portable eye movement testing equipment. The aim of this pilot study is to discover if these characteristics can be identified using portable eye movement testing equipment in patients with a confirmed diagnosis of myasthenia gravis.
Detailed description
The diagnosis of Myasthenia Gravis (MG) can be challenging, particularly in its ocular manifestation with current clinical procedures. Previous research has shown that fast eye movements in patients suffering with MG have quite specific characteristics that can be used to correctly diagnose the condition. The Saccadometer is a portable eye movement testing device that may provide the ability to detect the characteristics of fast eye movements that Myasthenia patients alone demonstrate - specifically these are hyperfast movements that are present when slower eye movements are impaired by the disease process. These fast movement characteristics are not present in defects of eye movements due to other aetiologies.
Saccadic properties of a small group of patients with a confirmed diagnosis of MG will be measured to identify if characteristic hyperfast saccades are present.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myasthenia Gravis | Other | Device: Quantitative measurement of eye movementsParticipants with a confirmed diagnosis of Myasthenia Gravis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient participants
- Confirmed diagnosis of Myasthenia Gravis by either a positive acetylcholine antibody serum test (AChR) and/or a positive single fibre electromyograph (SFEMG) test.
- Patient participants must have also had at least one episode of diplopia and/or eye movement abnormality attributed to their diagnosis of MG.
- Must have no history of eye movement abnormality
- No have no history of other auto-immune disease (specifically diabetes, Thyroid Eye Disease and Chronic External Ophthalmoplegia).
Key exclusion criteria (4 listed)
- Patients without confirmed Myasthenia Gravis diagnosis by means of either a positive AChR serum test and/or a positive SFEMG test.
- Patients with confirmed Myasthenia Gravis who have not had at least one episode of diplopia and or ptosis.
- Patients with current or previous episodes of ocular motility dysfunction that have a confirmed diagnosis other than Myasthenia Gravis.
- Any healthy participant found to have an abnormality of vision or eye movement upon screening or a history of auto-immune disease.
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 |
|---|---|---|
| Quantitative measurement of eye movementsSaccadometer © - diagnostic device: non-invasive quantitative assessment of eye movement | Device | Myasthenia Gravis |
Primary outcome
Saccadic Peak Velocity
Time frame: Measured at first and only contact point within study i.e. day one and then not tested again
Participants will be recruited, consented and tested at a single visit during their routine clinical visit, up to one year after being recruited. Quantitative assessment of their eye movements using the Saccadometer will be assessed at that point of contact and the outcome measure recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Myasthenia Gravis
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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.
Craig Murray, MRes principal investigator
University of Liverpool
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative measurement of eye movements in people with Myasthenia Gravis, run by University of Liverpool.
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 6 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: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Saccadic Peak Velocity (time frame: Measured at first and only contact point within study i.e. day one and then not tested again). 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 18 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.