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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07282691
Enrollment
150
Registered
2025-12-15
Start date
2025-04-01
Completion date
2028-09-29
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MTBI - Mild Traumatic Brain Injury

Keywords

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

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.

Detailed 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.

Interventions

None listed

Sponsors

Salus University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

MeasureTime frameDescription
Number of participants with abnormal positive fusional vergenceBaseline and visit 2, which occurs 8 weeks after the baseline visitCompensatory 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.
Number of participants with abnormal vergence facilityBaseline and visit 2, which occurs 8 weeks after the baseline visitThis 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
Number of participants with abnormal accommodative amplitudeBaseline and visit 2, which occurs 8 weeks after the baseline visitA 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
Number of participants with abnormal accommodative facilityBaseline and visit 2, which occurs 8 weeks after the baseline visitThis 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.

Countries

United States

Contacts

Primary ContactKatie Holmbeck, BS
kh3482@drexel.edu2157801429
Backup ContactMitchell Scheiman, OD, PhD
ms5758@drexel.edu2157801427

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026