Clinical trial Recruiting at 1 site Observational Ages 18 to 35

Validating vision tests for concussion-related eye movement problems

Official title: Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders

Run by Salus University · NCT07282691 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 35 Years
SexAll
Enrollment150 (estimated)
SponsorSalus University
Academic / other
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedApril 1, 2025
Main results expectedSeptember 29, 2028
Study endsSeptember 29, 2028
Registry record updatedDecember 15, 2025
Trial IDNCT07282691 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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).

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • The Eye Institute
    Philadelphia, Pennsylvania, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.