Trials / Completed
CompletedNCT04993833
Inter-Device Reliability of the NPi-300 Pupillometer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.
Detailed description
Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF. If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NPi-200 and NPi-300 pupillometers | Device which measures PLR. |
Timeline
- Start date
- 2021-08-25
- Primary completion
- 2022-08-31
- Completion
- 2022-08-31
- First posted
- 2021-08-06
- Last updated
- 2022-09-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04993833. Inclusion in this directory is not an endorsement.