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NCT Number: NCT07282691

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Eye Institute

Philadelphia, Pennsylvania, 19141, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants with abnormal near point of convergence

    Time frame: Baseline 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.

Secondary outcomes

  1. Number of participants with abnormal positive fusional vergence

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

    Compensatory ability to overcome exophoria. A handheld prism bar will be used along with a vertical column of 20/30 letters. The prism will be placed before one eye, and the participant will be asked to maintain clear, single vision. Participants will then report when the target becomes blurred (blur), then double (diplopia), and finally return to single vision (recovery). The unit of measure is prism diopters, and it will be measured three times, with 10 seconds in between each measurement, and averaged for each participant.

  2. Number of participants with abnormal vergence facility

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

    This is a measure of vergence velocity. Using a 12-base-out and 3-base-in prism, participants will be instructed to regain clear single vision as quickly as possible. The investigator will count the number of times this can be accomplished in one minut.e

  3. Number of participants with abnormal accommodative amplitude

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

    A near point rod will be used along with a column of 20/30 letters. The test will be performed monocularly, first with the left eye covered, and then with the right eye covered. The target will slowly be moved towards the participant, and the participant will be instructed to report when the target becomes blurred. The amplitude of accommodation will be measured 3 times, with 10 seconds in between each measure

  4. Number of participants with abnormal accommodative facility

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

    This test assesses the speed and endurance of accommodation. A column of 20/30 letter will be used along with a timer, and +2.00D and -2.00D lens flippers. The test will be performed monocularly. The +2.00D lens will be placed before the participant's eye, and the participant will be asked to clear the target as quickly as possible. Once the participant clears the target, the -2.00D lens will be placed before the eye, and the participant will be asked to report when the target becomes clear again. This will be repeated as many times as possible within one minute. The investigator will report how many times this occurs in one minute.

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Holmbeck, BS

CONTACT

[email protected]

2157801429

Mitchell Scheiman, OD, PhD

CONTACT

[email protected]

2157801427

Sponsors and collaborators

Lead sponsor

Salus University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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