Validating vision tests for concussion-related eye movement problems
Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders
Salus University · NCT07282691
This project will test whether a set of visual endurance exams can reliably measure eye-movement problems in people 1–6 months after a mild concussion.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Salus University (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07282691 on ClinicalTrials.gov |
What this trial studies
Investigators will recruit 50 people with a recent mTBI and 100 people without mTBI to compare performance on a series of visual endurance tests that require sustained visual responses. Participants will undergo standardized vision examinations to confirm acuity and screen for other eye diseases, then complete the endurance protocols while researchers record objective performance and symptom reports. The team will calculate expected values for each test, look at variability between individuals, and collect qualitative data about discomfort or symptom provocation during testing. Results will be used to determine which measures are reliable and feasible as outcome measures in future rehabilitation studies.
Who should consider this trial
Good fit: Ideal candidates are people 1 to 6 months after a mild traumatic brain injury who have near-normal distance acuity (≥20/25 in each eye) and symptomatic convergence insufficiency (CISS score >21).
Not a fit: Patients with moderate or severe TBI, significant ocular disease or manifest strabismus, recent intraocular injury, uncontrolled systemic diseases affecting eye movements, or cognitive impairments that prevent testing are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, these validated tests could give clinicians and researchers reliable tools to measure concussion-related oculomotor dysfunction and track recovery or response to treatments.
How similar studies have performed: Prior smaller studies of oculomotor and convergence testing have shown promising signals, but formal validation of sustained visual endurance measures specifically in mTBI is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of mTBI within previous 1 to 6 months * Distance visual acuity better than or equal to 20/25 in each eye * Score \>21 on Convergence Insufficiency Symptom Survey Exclusion Criteria: * Diagnosis of moderate or severe TBI; \> 30-min loss of consciousness * Not wearing required refractive error) * Disease(s) known to affect oculomotor system (multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease)-Manifest strabismus or intraocular injury (evaluated at vision examination) * Cognitive delays that may impact testing
Where this trial is running
Philadelphia, Pennsylvania
- The Eye Institute — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Katie Holmbeck, BS
- Email: kh3482@drexel.edu
- Phone: 2157801429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MTBI - Mild Traumatic Brain Injury, mTBI, convergence insufficiency, concussion, concussion-related vision disorders, vision rehabilitation, vision therapy