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

S

Salus University

Status

Enrolling

Conditions

MTBI - Mild Traumatic Brain Injury

Study type

Observational

Funder types

Other

Identifiers

NCT07282691
2406010608

Details and patient eligibility

About

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

Full description

Participants with (n=50) and without (n=100) a history of mTBI will be recruited. Investigators will study the use of a series of visual endurance tests (tests that require sustained visual responses over a period of time). In addition to developing expected values for these tests, investigators will also after qualitative data about discomfort levels during testing.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

control participants
Description:
no history of mTBI
mTBI group
Description:
history of mTBI

Trial contacts and locations

1

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Central trial contact

Mitchell Scheiman, OD, PhD; Katie Holmbeck, BS

Data sourced from clinicaltrials.gov

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