Observational Study on mTBI-Related Vision Problems

This study is looking at ways to better measure vision problems that can happen after a mild traumatic brain injury (mTBI). Researchers will be studying a series of visual endurance tests, which are tests that require you to use your eyes for a sustained period. They want to see if these tests can accurately show changes in a specific vision issue called near point of convergence (how close your eyes can focus together). The study is not testing any new drugs or treatments. You might be able to join if you are between 18 and 35 years old, have had a mild traumatic brain injury in the last 1 to 6 months, and have good distance vision. The study aims to enroll 150 participants, but the current recruitment status is unclear.

Study design
This is an observational study, meaning no intervention is given. It plans to enroll 150 participants, with 50 having a history of mTBI and 100 without.
What's involved
You would participate in baseline visual tests and then return for a second visit 8 weeks later for more tests. The study also involves reporting your discomfort levels during testing.
Compensation
Not stated in the trial record.
Follow-up
Your near point of convergence will be measured at baseline and again at a second visit, 8 weeks after the baseline visit.

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NCT07282691

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

Recruiting
Not specifiedAges 18–35Observational
Salus University
~150 participants
Updated 2025-12-15 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with abnormal near point of convergence
Measured over Baseline and visit 2, which occurs 8 weeks after the baseline visit
MTBI - Mild Traumatic Brain Injury
1 sites across 1 states
Pennsylvania1
  • Mitchell Scheiman · STUDY_CHAIR · Pennsylvania College of Optometry at Drexel University

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Eligibility criteria

Inclusion

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

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
  • Number of participants with abnormal near point of convergenceBaseline and visit 2, which occurs 8 weeks after the baseline visit

    The ability to converge the eyes. A near point rod will be used with a 20/30 column of letters. The target will be moved towards the participant slowly, and when diplopia occurs, this will be recorded as the NPC break. The target will then be moved away from the eyes until single vision is regained, and this will be recorded as the NPC recovery. The unit of measure is cm and the NPC will be measured 3 times, with 10 seconds in between each measure, and averaged for each participant.