Recruiting

Observational StudyEstablishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT02804438

Conditions

Critical Illness

Neuropathy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Critical Illness

Neuropathy

Study ID

NCT02804438

Start date

Jul, 2015

Status verified date

Oct, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Oculomotor evaluation of pupillary variance during ICU admission [ Time Frame: Daily at 9:00am ]

Central Contacts and Locations

Central contacts

DaiWai M Olson, PhD

214-648-8946 DaiWai.Olson@UTSouthwestern.edu

Maria E Denbow

214-648-2861 Maria.Denbow@utsouthwestern.edu

Locations

Maria E Denbow

Recruiting

Dallas, Texas, United States, 75390

Contacts

Maria E Denbow

214-648-2861 Maria.Denbow@utsouthwestern.edu

DaiWai Olson, PhD

214-648-8946 DaiWai.Olson@UTSouthwestern.edu

Principal Investigator:

DaiWai Olson, PhD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-10-22.