MTBI - Mild Traumatic Brain InjuryNCT07282691
Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders
An observational study of MTBI - Mild Traumatic Brain Injury, run by Salus University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- MTBI - Mild Traumatic Brain Injury
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 29 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: mTBI
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Eye Institute
Philadelphia, Pennsylvania, 19141
About this study
The specific aim of this project is to validate clinical tests to be used as outcome measures in studies of mTBI-related vision problems.
Read the 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.
- Conditions
- MTBI - Mild Traumatic Brain Injury
- Keywords
- mTBI, convergence insufficiency, concussion, concussion-related vision disorders, vision rehabilitation, vision therapy
- Medical subject headings
- Brain Concussion, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control participants | no history of mTBI | |
| mTBI group | history of mTBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with abnormal near point of convergence
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.
Measured: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Secondary outcomes (4)
Number of participants with abnormal positive fusional vergence
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.
Measured: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal vergence facility
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
Measured: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal accommodative amplitude
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
Measured: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal accommodative facility
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.
Measured: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Apr 2025
- Primary completion29 Sep 2028 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTBI - Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Scheiman, Study chair, Pennsylvania College of Optometry at Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282691
- Sponsor's protocol ID
- 2406010608
- Status last verified
- Dec 2025
- First submitted
- 12 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will only be shared with the study investigators. REDCap will be used for data collection.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders
- ClinicalTrials.gov ID
- NCT07282691
- Acronym / sponsor ID
- 2406010608
- Conditions
- MTBI - Mild Traumatic Brain Injury
- Keywords
- mTBI, convergence insufficiency, concussion, concussion-related vision disorders, vision rehabilitation, vision therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control participants | – | –no history of mTBI |
| mTBI group | – | –history of mTBI |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- mTBI
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Number of participants with abnormal positive fusional vergence
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal vergence facility
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal accommodative amplitude
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Number of participants with abnormal accommodative facility
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. The IPD will only be shared with the study investigators. REDCap will be used for data collection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell Scheiman study chair
Pennsylvania College of Optometry at Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MTBI - Mild Traumatic Brain Injury, run by Salus University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Holmbeck, BS (2157801429, kh3482@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.