Clinical trial NCT05862571: Screening Instruments for Measuring Visual Symptoms in Victims of Concussion
Official title: Screening Instruments for Measuring Visual Symptoms in Victims of Concussion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Concussion
mTBI - Mild Traumatic Brain Injury
Keywords: mTBI
Ocular Motility Disorders
Oculomotor Disorder
Mild Traumatic Brain Injury
Concussion
Mild Concussion
Eye tracking
Questionnaire
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: IT University of Copenhagen
name: The Danish Victims Fund
name: Synoptik-Fonden
name: University of Copenhagen
First posted: 2023-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility 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

Primary outcomes:
measure: VISCOM Questionnaire
timeFrame: Estimated duration: 20 minutes
Secondary outcomes:
measure: The Rivermead Post Concussion Symptoms Questionnaire (RPQ)
timeFrame: Estimated duration in total: 5 minutes
measure: Vergence facility
timeFrame: Estimated duration in total: 2 minutes
measure: Fusional vergence at near
timeFrame: Estimated duration in total: 2 minutes
measure: Monocular amplitude of accommodation
timeFrame: Estimated duration in total: 2 minutes
measure: Monocular accommodation facility
timeFrame: Estimated duration in total: 2 minutes
measure: Horizontal and vertical phoria
timeFrame: Estimated duration in total: 2 minutes
measure: Near point of convergence
timeFrame: Estimated duration in total: 5 minutes
measure: Saccadic eye movement
timeFrame: Estimated duration in total: 10 minutes
measure: Reaction test
timeFrame: Estimated duration in total: 5 minutes
measure: Pattern test
timeFrame: Estimated duration in total: 5 minutes
measure: Saccade test
timeFrame: Estimated duration in total: 5 minutes
measure: Smooth pursuit test
timeFrame: Estimated duration in total: 5 minutes
Other outcomes:
measure: Nystagmus test
timeFrame: Estimated duration in total: 5 minutes
measure: Stereopsis
timeFrame: Estimated duration in total: 2 minutes.
measure: Vectogram no.12
timeFrame: Estimated duration in total: 2 minutes
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg hospital
state: Capital Region
Study officials:
affiliation: Bispebjerg Hospital
name: Hana M Rytter, PhD
role: PRINCIPAL_INVESTIGATOR
References: