Measuring visual symptoms in concussion victims
Screening Instruments for Measuring Visual Symptoms in Victims of Concussion
This study is trying to create a questionnaire and eye tests to better understand and help people with vision problems after a mild brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 1 site (Copenhagen, Capital Region) |
| Trial ID | NCT05862571 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the understanding of visual dysfunction in individuals who have suffered from mild traumatic brain injury (mTBI). It will develop and validate a questionnaire to uncover subjective visual complaints and create eye tracking-based screening tools for use in various settings. The study will also explore the relationship between objective eye measurements and patients' subjective experiences to enhance diagnostic and treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 67 who have been diagnosed with mTBI and have ongoing visual symptoms for at least two months post-injury.
Not a fit: Patients with severe neurological disorders, active psychiatric conditions, or unregulated somatic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification and management of visual dysfunction in patients with mTBI.
How similar studies have performed: While the approach of using subjective and objective measures for visual dysfunction in mTBI is promising, it is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 and at near * 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
Where this trial is running
Copenhagen, Capital Region
- Bispebjerg hospital — Copenhagen, Capital Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Hana M Rytter, PhD — Bispebjerg Hospital
- Study coordinator: Ryan S Lauridsen, MA
- Email: ryan.lauridsen@cfh.ku.dk
- Phone: 45 93565023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.