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Eye-Tracking and questionnaire aim to catch hidden vision problems after concussion

NCT ID NCT05862571

Diagnosis Sponsor: Bispebjerg Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Visual problems after a mild traumatic brain injury often go unnoticed. Researchers at Bispebjerg Hospital are developing and testing a 42-item questionnaire and eye-tracking based screening tools to detect these issues. The study compares 100 adults with persistent symptoms after concussion to 100 uninjured controls, looking at how well self-reported symptoms match optometric and eye-tracking measurements.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a questionnaire and eye-tracking screening tools for visual symptoms after concussion
What this could lead to
If the tools work, doctors could spot visual problems after concussion earlier and refer patients for treatment sooner.
What could go wrong
The study measures whether the tools detect visual symptoms, not whether treating them helps. The questionnaire and eye-tracking tests may not prove reliable enough for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

Other studies related to the condition(s) this trial covers.