Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862571
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-03-23
Brief Title:
Screening Instruments for Measuring Visual Symptoms in Victims of Concussion
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
Screening Instruments for Measuring Visual Symptoms in Victims of Concussion
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISCOM
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None