Trials / Completed
CompletedNCT05047003
Oculogica Portable EyeBOX Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Oculogica, Inc. · Industry
- Sex
- All
- Age
- 5 Years – 67 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. The utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | EyeBOX Model EBX-4 (Portable version) | The portable EyeBOX takes less than 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high-speed camera continuously records gaze positions. The Portable EyeBOX software detects subtle changes in eye movements consistent with concussion and calculates a BOX score. |
Timeline
- Start date
- 2020-12-19
- Primary completion
- 2022-09-01
- Completion
- 2022-10-01
- First posted
- 2021-09-16
- Last updated
- 2023-09-07
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05047003. Inclusion in this directory is not an endorsement.