Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07380256
Eligibility Criteria:
Inclusion Criteria:
For All Participants (All Groups)
* Age 18 to 60 years
* Able to provide informed consent
Group-Specific Inclusion Criteria:
* Group 1: Abnormal Uncorrected Static Visual Acuity (No Vestibular Hypofunction) Normal peripheral vestibular function
* Group 2: Abnormal Uncorrected Static Visual Acuity + peripheral Vestibular Hypofunction
* Group 3: Binocular Vision Abnormalities (No Vestibular Hypofunction) Normal peripheral vestibular function
* Group 4: Binocular Vision Abnormalities + peripheral Vestibular Hypofunction
Individuals who have abnormal static visual acuity, a binocular vision abnormality (ocular misalignment, convergence insufficiency), and vestibular loss will be assigned to Group 4.
The following definitions will be used when determining group placement:
* Abnormal Static Visual Acuity: Uncorrected visual acuity (head is still) ≥0.30 logMAR in both eyes.
* Unilateral Vestibular Hypofunction: 60 ms VOR gain \<0.80 unilaterally for the lateral semicircular canal.
* Bilateral Vestibular Hypofunction: 60 ms VOR gain \<0.80 bilaterally for the lateral semicircular canals.
* Normal Vestibular Function: 60 ms VOR gain of 0.80 to 1.20 bilaterally for the lateral semicircular canals.
* Convergence Insufficiency: ≥6 cm near point of convergence.
* Ocular Misalignment: ≥4 prism diopters of manifest deviation of the eyes (tropia) on cover/uncover testing.
Exclusion Criteria:
* Diagnosis of fluctuating vestibular disorders (e.g., benign paroxysmal positional vertigo)
* Neurologic conditions (e.g., multiple sclerosis), dementia,
* Alcohol or drug abuse,
* A major psychiatric disorder (e.g., schizophrenia),
* Pain that limits cervical spine range of motion by \>50% or that results in an -altered gait pattern.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07380256
Study Brief:
Protocol Section:
NCT07380256