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

NCT ID: NCT07282691

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2028-09-29

Brief Summary

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

Detailed Description

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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.

Conditions

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MTBI - Mild Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control participants

no history of mTBI

No interventions assigned to this group

mTBI group

history of mTBI

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Salus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Scheiman

Role: STUDY_CHAIR

Pennsylvania College of Optometry at Drexel University

Locations

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The Eye Institute

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katie Holmbeck, BS

Role: CONTACT

2157801429

Mitchell Scheiman, OD, PhD

Role: CONTACT

2157801427

Other Identifiers

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2406010608

Identifier Type: -

Identifier Source: org_study_id

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