NCT02804438

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jul 2015Sep 2028

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

13.2 years

First QC Date

May 3, 2016

Last Update Submit

October 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oculomotor evaluation of pupillary variance during ICU admission

    Pupil size and reactivity per neurological pupil index

    Daily at 9:00am

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In-patient

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria E Denbow

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (3)

  • Privitera CM, Neerukonda SV, Aiyagari V, Yokobori S, Puccio AM, Schneider NJ, Stutzman SE, Olson DM; END PANIC Investigators. A differential of the left eye and right eye neurological pupil index is associated with discharge modified Rankin scores in neurologically injured patients. BMC Neurol. 2022 Jul 22;22(1):273. doi: 10.1186/s12883-022-02801-3.

  • Campos YA, Rana P, Reyes RG, Mazhar K, Stutzman SE, Atem F, Olson DM, Aiyagari V. Relationship Between Automated Pupillometry Measurements and Ventricular Volume in Patients With Aneurysmal Subarachnoid Hemorrhage. J Neurosci Nurs. 2022 Aug 1;54(4):166-170. doi: 10.1097/JNN.0000000000000657. Epub 2022 Jun 21.

  • Thakur B, Nadim H, Atem F, Stutzman SE, Olson DM. Dilation velocity is associated with Glasgow Coma Scale scores in patients with brain injury. Brain Inj. 2021 Jan 5;35(1):114-118. doi: 10.1080/02699052.2020.1861481. Epub 2020 Dec 21.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 3, 2016

First Posted

June 17, 2016

Study Start

July 1, 2015

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations