Recruiting

Observational Study

Sponsor:

Salus University

Code:

NCT07282691

Conditions

MTBI - Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

MTBI - Mild Traumatic Brain Injury

Study ID

NCT07282691

Start date

Apr 1, 2025

Status verified date

Dec, 2025

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Sep 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

control participants

no history of mTBI

mTBI group

history of mTBI

Primary outcome measure

  • Number of participants with abnormal near point of convergence [ Time Frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit ]

Central Contacts and Locations

Central contacts

Katie Holmbeck, BS

2157801429kh3482@drexel.edu

Mitchell Scheiman, OD, PhD

2157801427ms5758@drexel.edu

Locations

The Eye Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19141

More Information

Sponsor

Salus University

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • mTBI
  • convergence insufficiency
  • concussion
  • concussion-related vision disorders
  • vision rehabilitation
  • vision therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Salus University on 2025-12-15.