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Recruiting NCT07746167

Pupillary Dilation Reflex in Healthy Volunteers

— Observational Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention (observational study).
Who it may be relevant to
Registry conditions: Healthy Participants. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Relationship Between Neurostimulation Intensity and Pupillary Dilation Reflex (PRD) in Healthy Volunteers

Overview

This a single site, observational study that will examine how the pupil responds to neurostimulation under different conditions in healthy adults. The objective is to measure pupillary dilation reflex (PRD) in response to increasing neurostimulation intensities using the AlgometRx device.

Interventions

  • Other No intervention (observational study)
    No intervention

Primary outcome measures

  • Pupillary Dilation Amplitude in Response to Increasing Neurostimulation Intensity Measured by AlgometRx Infrared Pupillometer [Time frame: Day 1]
Secondary outcome measures (5)
  • Baseline Pupil Diameter Variability During the Pre-Stimulation Period Measured by AlgometRx Infrared Pupillometer [Time frame: Day 1]
  • Area Under the Pupillary Dilation Curve (AUC) Measured by AlgometRx Infrared Pupillometer [Time frame: Day 1]
  • Difference in Pupillary Dilation Amplitude Between Ambient Lighting Conditions Measured by AlgometRx Infrared Pupillometer [Time frame: Day 1]
  • Inter-Ocular Agreement in Pupillary Dilation Amplitude Measured by AlgometRx Binocular Handheld Attachment [Time frame: Day 1]
  • Percentage of Participants With Successful Simultaneous Binocular Pupillary Recording Using the AlgometRx Binocular Handheld Attachment [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Age 18-60 years.
  • In good general health (self-reported).
  • Able and willing to provide written informed consent.

Exclusion criteria

  • Eye pathology that prevents accurate pupillometry.
  • Pregnancy (Self-Report)
  • Diagnosis of autoimmune disorders.
  • Diagnosis of any neuropathic disorder
  • Inability to complete questionnaires.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Children's National Hospital — Washington D.C.

Identifiers

NCT: NCT07746167 · STUDY00001697

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗