RecruitingNot Applicable

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

United States150 participantsStarted 2025-04-01

Plain-language summary

The specific aim of this project is to validate clinical tests to be used as outcome measures in studies of mTBI-related vision problems.

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants with abnormal near point of convergence

Timeframe: Baseline and visit 2, which occurs 8 weeks after the baseline visit

Trial details

NCT IDNCT07282691

SponsorSalus University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-09-29

Contact for this trial

Katie Holmbeck, BS

2157801429 kh3482@drexel.edu

View on ClinicalTrials.gov More MTBI - Mild Traumatic Brain Injury trials