Critical IllnessENDPANICNCT02804438
Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care
An observational study of Critical Illness and Neuropathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Neuropathy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In-patient
Who may be able to join
- 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.
Who cannot join
- Out-patients
- Patients that do not have orders for regular pupillary assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maria E Denbow
Dallas, Texas, 75390
Maria E Denbow, 214-648-2861, Maria.Denbow@utsouthwestern.edu
DaiWai Olson, PhD, 214-648-8946, DaiWai.Olson@UTSouthwestern.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Critical Illness, Neuropathy
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Oculomotor evaluation of pupillary variance during ICU admission
Pupil size and reactivity per neurological pupil index
Measured: Daily at 9:00am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NeurOptics Inc
- Responsible party
- Principal investigator, DaiWai Olson, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804438
- Sponsor's protocol ID
- STU 062015-005
- Acronym
- ENDPANIC
- Status last verified
- Oct 2026
- First submitted
- 3 May 2016
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Doyle BR, Aiyagari V, Yokobori S, Kuramatsu JB, Barnes A, Puccio A, Nairon EB, Marshall JL, Olson DM. Anisocoria After Direct Light Stimulus is Associated with Poor Outcomes Following Acute Brain Injury. Neurocrit Care. 2024 Dec;41(3):1020-1026. doi: 10.1007/s12028-024-02030-1. Epub 2024 Jun 25.
PubMed 38918339Privitera 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.
PubMed 35869429Campos 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.
PubMed 35776519Thakur 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.
PubMed 33347373
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care
- ClinicalTrials.gov ID
- NCT02804438
- Acronym / sponsor ID
- ENDPANIC / STU 062015-005
- Conditions
- Critical Illness, Neuropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- NeurOptics Inc
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In-patient
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Out-patients
- Patients that do not have orders for regular pupillary assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oculomotor evaluation of pupillary variance during ICU admission
Time frame: Daily at 9:00am
Pupil size and reactivity per neurological pupil index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Derived from this study: PubMed 38918339Doyle BR, Aiyagari V, Yokobori S, Kuramatsu JB, Barnes A, Puccio A, Nairon EB, Marshall JL, Olson DM. Anisocoria After Direct Light Stimulus is Associated with Poor Outcomes Following Acute Brain Injury. Neurocrit Care. 2024 Dec;41(3):1020-1026. doi: 10.1007/s12028-024-02030-1. Epub 2024 Jun 25.
- Derived from this study: PubMed 35869429Privitera 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.
- Derived from this study: PubMed 35776519Campos 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.
- Derived from this study: PubMed 33347373Thakur 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Neuropathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DaiWai M Olson, PhD (214-648-8946, DaiWai.Olson@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oculomotor evaluation of pupillary variance during ICU admission (time frame: Daily at 9:00am). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804438, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.