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Screening instruments for measuring visual symptoms in victims of concussion

NCT ID NCT05862571

NEW Sponsor: Bispebjerg Hospital Source: ClinicalTrials.gov ↗

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Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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Ongoing
Running, but no longer taking on new participants.
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Stopped early
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Cancelled
Cancelled before anyone took part.

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When the status isn't known

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

Visual dysfunction after mild traumatic brain injury (mTBI) is common but often remain undiscovered during longer periods of time. No valid, reliable and easy-to-use screening instrument for uncovering visual dysfunction exists. Furthermore, it is unknown whether optometric measurements currently used in assessing vision problems are consistent with patients' subjective complaints experienced in everyday life. A better understanding of patients' visual challenges combined with objective measurements, will contribute to a better and more efficient diagnostic investigation and treatment. The aim of this study is to get a better understanding of patients who are suffering from visual dysfunction after mTBI. This understanding will be gained by: 1. developing and validating a questionnaire for uncovering subjective visual complaints in subjects with mTBI. 2. developing eye tracking based screening tools applicable both in- and outside of optometry clinics 3. examining relationships between self-reported data, eye tracking measurements and optometric measurements. The study will consist of N = 200 subjects. N = 100 of the subjects are suffering from mTBI (commotio group). The second group N = 100 is the non-injured group that preferably will consist of relatives to the subjects in the commotio group. The subjects in both groups have to answer the questionnaires regarding subjective visual complains, undergo optometric tests and undergo eye tracking measurements.

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Study facts

What this study's own registry entry says, in plain language.

Participants

197 people

The number who actually took part.

Started

Dec 2022

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The subjects (N=200) will be recruited through 5 optometric clinics on Zealand, DK. The objective is to recruit 100 individuals with mTBI and 100 individuals without mTBI (control group). The control group will consist of relatives of the individuals with mTBI, preferably a partner or a sibling.

Ages

18 to 67 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Individuals may be included if they: * are adults between the ages 18 and 67 * have been diagnosed with mTBI by a doctor (emergency room or general practice) either exclusively or with another diagnosis e.g. fracture, neck trauma (doesn't apply to control group) * can read and understand Danish * continuously have symptoms related to trauma ≥ 2 months and ≤ 24 months after trauma origin (doesn't apply to control group) * have best corrected visus at 0.8 or better in both eyes at distance * have given informed consent and willingness to participate in the study Exclusion Criteria: The following will be excluded if individuals: * are diagnosed with one of the following neurological disorders: severe head trauma, brain tumor, Parkinson's disease, multiple sclerosis, dementia * are diagnosed with a current active psychiatric disorder * are diagnosed with one of the following somatic disorders which are unregulated: diabetes mellitus, metabolic disorders * have a verified alcohol or drug abuse * have amblyopia (that is, two lines difference or more in best corrected visus between the two eyes) * have other visual problems such as constant strabismus, a history of strabismus surgery, congenital nystagmus and recognized eye illnesses such as glaucoma, age-related macular degeneration (AMD) * have received vision therapy by an optometrist in relation to resent mTBI

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Conditions

The condition(s) this trial relates to.

Brain Concussion Ocular Motility Disorders traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain concussion Mtbi - mild traumatic brain injury

Contacts and locations

Locations

  • Bispebjerg hospital

    Copenhagen, Capital Region, 2400, Denmark

More trials for these conditions

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