Pupillary Dilation Reflex in Healthy Volunteers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorChildren's National Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-60 years.

In good general health (self-reported).

Able and willing to provide written informed consent.

Disqualifiers

Eye pathology that prevents accurate pupillometry.

Pregnancy (Self-Report)

Diagnosis of autoimmune disorders.

Diagnosis of any neuropathic disorder

Trial population

This study will enroll up to 60 healthy adult volunteers between the ages of 18 and 60

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention (observational study)

    Other intervention

    No intervention

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Healthy Volunteers1 intervention

Trial outcomes

Primary outcomes

1

Pupillary Dilation Amplitude in Response to Increasing Neurostimulation Intensity Measured by AlgometRx Infrared Pupillometer

Pupillary dilation amplitude is defined as the maximum increase in pupil diameter from the pre-stimulus baseline, measured in millimeters (mm) using the AlgometRx infrared pupillometer. Pupil diameter is recorded before, during, and for 10 seconds following each 1-second stimulus. Amplitude is assessed at each stimulation intensity, beginning at 1.0 mA and increasing in 1 mA steps until participant perception, followed by measurements at 2 mA and 4 mA above the perception threshold, at each of three frequencies (5 Hz, 250 Hz, and 2000 Hz). Reported as the mean pupillary dilation amplitude in millimeters at each intensity and frequency combination.

Time frame
Day 1

Secondary outcomes

1

Baseline Pupil Diameter Variability During the Pre-Stimulation Period Measured by AlgometRx Infrared Pupillometer

Variability of pupil diameter recorded by the AlgometRx infrared pupillometer during the pre-stimulation baseline period, while participants fixate on a visual marker in a quiet room under controlled lighting for up to 5 minutes. Variability is calculated as the standard deviation of pupil diameter, in millimeters (mm), across the final 30 seconds of the baseline recording. Reported as the mean standard deviation in millimeters.

Time frame
Day 1
2

Area Under the Pupillary Dilation Curve (AUC) Measured by AlgometRx Infrared Pupillometer

Area under the curve (AUC) is calculated from the pupil diameter-time curve recorded over the 10-second period following each 1-second stimulus, using the AlgometRx infrared pupillometer, and is expressed in millimeter-seconds (mm\*s). AUC is assessed at each stimulation intensity, beginning at 1.0 mA and increasing in 1 mA steps until participant perception, followed by measurements at 2 mA and 4 mA above the perception threshold, at each of three frequencies (5 Hz, 250 Hz, and 2000 Hz). Reported as the mean AUC in millimeter-seconds at each intensity and frequency combination.

Time frame
Day 1
3

Difference in Pupillary Dilation Amplitude Between Ambient Lighting Conditions Measured by AlgometRx Infrared Pupillometer

Within-participant difference in pupillary dilation amplitude, measured in millimeters (mm) by the AlgometRx infrared pupillometer, between testing under approximately 100 lux and approximately 400 lux ambient lighting. Amplitude is defined as the maximum increase in pupil diameter from the pre-stimulus baseline. Reported as the mean within-participant difference in millimeters.

Time frame
Day 1
4

Inter-Ocular Agreement in Pupillary Dilation Amplitude Measured by AlgometRx Binocular Handheld Attachment

Agreement between left-eye and right-eye pupillary dilation amplitude recorded simultaneously using the AlgometRx binocular handheld attachment under identical stimulation and lighting conditions. Amplitude is defined as the maximum increase in pupil diameter from the pre-stimulus baseline, measured in millimeters. Agreement is expressed as an intraclass correlation coefficient (ICC) ranging from 0 to 1, where higher values indicate greater agreement between eyes. Reported as the ICC with a 95% confidence interval.

Time frame
Day 1

Other outcomes

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