An observational study in All Conditions and All, sponsored by Head Diagnostics. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Head Diagnostics · Observational
To evaluate the reliability of using the iTremor device to accurately measure Ocular Microtremor (OMT) across a diverse cohort, representative of the US population, with a view to establishing this as a standard measurement tool for OMT.
This multisite study intends to evaluate the performance of the iTremor device developed for the measurement of 'Ocular Microtremor' (OMT) - a very high frequency, very small vibration present in the eye. The iTremor is the first non-invasive technique to provide an output of OMT, reported as frequency (Hertz) at the point of care.
The current study is a prospective, observational, multicenter study of the safety and reliability of the iTremor device to obtain an ocular microtremor (OMT) measurement in subjects ≥18 years in a diverse cohort of the US population. By reporting the repeatability of the OMT reading, the study intends to support establishing this as a standard, point of care measurement tool for OMT.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 300 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →This is the only study on the registry with Head Diagnostics as lead sponsor.
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The study will enroll 120 US subjects total, 18 years of age and older, reflecting the gender, age and racial diversity of the US population. Health status and history will be documented to reflect an all-comers participant group.
Exclusion criteria:
Participants aged 18 and over representing the gender, age and racial diversity of the US population and of varied health status.
Reliability of the iTremor device to measure ocular microtremor (OMT) in a diverse US population.
To establish efficacy (performance/reliability) of iTremor to measure ocular mircotremor (OMT) reported in Hertz. Intra-operator, intra-device reliability will be assessed via repeated measures taken periprocedurally at one visit, utilizing the Intraclass Correlation Coefficient statistical tool (reported via single measures and average measures).
Time frame: Repeated measures to be performed periprocedurally during a single visit (Day 1)
Reliability of the iTremor device to measure ocular microtremor (OMT) across operators.
To establish efficacy (performance/reliability) of iTremor to measure ocular microtremor (OMT) reported in Hertz. Inter-operator, intra-device reliability will be assessed across different operators via repeated measures taken periprocedurally at one visit, utilizing the Intraclass Correlation Coefficient statistical tool (reported via single measures and average measures).
Time frame: Repeated measures performed periprocedurally during a single visit (Day 1)
Occurrence of adverse and or serious adverse events
To establish safety of the device, the rate of adverse events and serious adverse events believed to be procedure or device related will be evaluated. The timeframe for assessment of events is from the time of the procedure until 24 hours post procedure.
Time frame: 24 hours from the time of the procedure.
Reporting the range of ocular microtremor (OMT) values across a diverse population assessed with the iTremor device .
Report the range of ocular microtremor (OMT) values measured and detected across a diverse population of participants ages, health status and ethnicity. Measurements will be taken with the iTremor device and results will be reported in Hertz. Measurements will be taken periprocedurally during one visit.
Time frame: Repeated measures performed periprocedurally during a single visit (Day 1)
Plan to share: Undecided — To be determined by investigator agreements.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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