Pilot Study: Use of the Saccadometer to Detect Characteristic Saccadic Peak Velocity in Myasthenia Gravis Patients

NCT06501794 | Completed DMC

• 1 other identifier: UoL001162
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Myasthenia Gravis

Keywords

Saccades

Outcome Measures

Primary Outcomes (1)

• 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 at first and only contact point within study i.e. day one and then not tested again

Study Arms (1)

Myasthenia Gravis

OTHER

Participants with a confirmed diagnosis of Myasthenia Gravis

Device: Quantitative measurement of eye movements

Interventions

Quantitative measurement of eye movements DEVICE

Saccadometer © - diagnostic device: non-invasive quantitative assessment of eye movement

Myasthenia Gravis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Craig Murray, MRes

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: July 15, 2024
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share