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NCT Number: NCT02804438

Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

The purpose of this study is to collect a large amount of data that may assist in addressing the gap in knowledge of understanding pupillometer readings using a pupillometer device.

The aim of this project is to establish normative values for pupillometer data. Measures of central tendency will be developed for the variables provided by automated pupillary exams, which will provide an enhanced understanding of clinically appropriate pupil values for size, reactivity, and neurological pupil index.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Data will be collected on patients in the intensive care units at the selected hospitals on patients who have been assigned, by the attending physician, to have regular pupillary assessments, and in whom staff nurses are performing pupillary assessments with the pupillometer. While a sample size estimate would be considered inappropriate for registry development, power analysis techniques were used to examine the potential of this registry to generate adequate information to begin to fully describe normative data for pupillary exams. Using the assumption that the desire is to understand neurological pupil index (NPi) and size differences within 0.1, and that the spread of data would be approximately normally distributed, a minimum of 3,250 observations is required (alpha = 0.05, beta = 0.80). It must, however, be repeated that this is simply a rough estimate. The registry data generated will, in fact, be the source of data from which future studies will be powered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Data will be collected on patients admitted to enrolling hospitals who have been assigned, by the attending physician, to have regular pupillary assessments, and in whom staff nurses are performing pupillary assessments with the pupillometer.

Exclusion criteria

  • Out-patients
  • Patients that do not have orders for regular pupillary assessments

Treatment and study plan

Primary outcomes

  1. Oculomotor evaluation of pupillary variance during ICU admission

    Time frame: Daily at 9:00am

    Pupil size and reactivity per neurological pupil index

Study contacts

Contact information is provided by the study sponsor or research team.

DaiWai M Olson, PhD

CONTACT

[email protected]

214-648-8946

Maria E Denbow

CONTACT

[email protected]

214-648-2861

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • NeurOptics Inc

Registry information

Acronym: ENDPANIC

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2016
Registry last updated
Oct 22, 2025

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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