Assessment of repeatability of a clinical automated pupillometer

Abstract

Purpose To determine the repeatability of a clinical pupillometer in healthy participants with a 5 and 30−minute test−retest break for both Swinging-Flashlight and Low-High Luminance approach.

Methods 20 healthy participants (mean age: 27 years ±5; 9 females) placed their heads into the device’s headrest and fixated a central spot. A Swinging-Flashlight approach evoked a pupillary light reflex, stimulating alternatingly 8 times each eye by a brief diffuse white light flash followed by a continuous measurement of constriction and dilation of the direct and consensual pupils. For the Low-High Luminance setting, continuous measurements of pupil diameters for a 5 second low luminance display followed by a 5 second high luminance white light. Pupillary light reflex parameters for each test and each eye were calculated by the device. Repeatability was investigated after a 5-minute break time and during a control experiment for 21 participants after a 30-minute break for each approach in counterbalanced order using Bland-Altman analysis.

Results Overall, many parameters for both Swinging-Flashlight and Low-High Luminance approach showed retest biases for all pupil light reflex parameters after a 5-minute test-retest break. These biases were almost completely reduced after a 30-minute break between test and retest for both approaches. The test-retest variabilities as expressed using the Coefficient of Repeatability was reduced after 30-minutes for the majority of the Low-High Luminance results but not for results of the Swinging-Flashlight method.

Conclusions Clinical pupillometry includes the Swinging Flashlight Test (SFL) and Low-High Luminance assays. In SFL, many pupillary dynamic metrics showed test-retest bias at a 5-minute interval, whereas relative afferent pupillary defect (RAPD) measurements remained unbiased at both 5 and 30-minute intervals. Similarly, Low-High Luminance testing showed minimal bias after 30 minutes but exhibited bias at the 5-minute interval. Thus, when evaluating multiple pupillary parameters in scientific or clinical settings, RAPD is less susceptible to bias, while other metrics require longer intervals between testing and retesting.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval for the study was granted by the University of California, Irvine's Institutional Review Board (IRB number: 20195254), in accordance with the ethical standards outlined in the Declaration of Helsinki (1975).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

All relevant data are within the manuscript and its Supporting Information files.

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