Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: MTBI - Mild Traumatic Brain Injury. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Number of participants with abnormal near point of convergence [Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The Eye Institute — Philadelphia
Identifiers
NCT: NCT07282691 · 2406010608