Trials / Completed
CompletedNCT03966404
EyeBOX Concussion Study and Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- Oculogica, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | EyeBOX device | The EyeBOX medical device tracks a patient's eye movement and calculates a BOX Score ranging from 0-20. The BOX score is interpreted as a binary classification for eye movement abnormalities, where anything equal to or greater than 10 is a positive result for the initial evaluation of concussion and everything below 10 is negative. |
Timeline
- Start date
- 2019-08-05
- Primary completion
- 2023-06-01
- Completion
- 2023-06-01
- First posted
- 2019-05-29
- Last updated
- 2023-09-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03966404. Inclusion in this directory is not an endorsement.