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Completed

NCT Number: NCT04993833

Inter-Device Reliability of the NPi-300 Pupillometer

The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clements University Hospital

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Patient Cohort):

  • Subjects will be included if they are adults (>18 years of age) and have a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Subjects also have to be admitted to the enrolling site. Persons consenting for the study (whether patient or LAR) will need to be able to consent for the study in English.

Exclusion criteria

(Patient Cohort):

  • Patients that will be excluded from the study are those that are prisoners, under 18 years of age, or pregnant women.

Inclusion criteria

(Healthy Control Cohort):

  • Staff in the enrolling site

Exclusion criteria

(Healthy Control Cohort):

  • None

Treatment and study plan

NPi-200 and NPi-300 pupillometers

Device

Device which measures PLR.

Primary outcomes

  1. Pupil's reaction to light as measured by Neurological Pupil Index (NPI)

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • NeurOptics Inc

Registry information

Acronym: TRIPLE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2021
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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