Clements University Hospital
Dallas, Texas, 75235, United States
NCT Number: NCT04993833
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.
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Notify Me18 year and older
All sexes
Observational
Dallas, Texas, 75235, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Patient Cohort):
Exclusion criteria
(Patient Cohort):
Inclusion criteria
(Healthy Control Cohort):
Exclusion criteria
(Healthy Control Cohort):
Device which measures PLR.
Time frame: 1 year
Pupil's reaction to light as measured by Neurological Pupil Index (NPI) algorithm using pupillometer device that grades the pupil's reaction to light on a scale between 0 and 5. The Inter-device reliability is assessed using Cohen's Kappa method: values ≤ 0 as indicating no agreement.
University of Texas Southwestern Medical Center
Other
Acronym: TRIPLE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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