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OpenTrials
Completed

NCT Number: NCT05717244

Comparison of Two Different Pupillometer

With the development of refractive surgery, the size of scotopic pupil has been widely concerned by clinicians. Historically, the measurement of pupil size included the use of a pupil ruler, which is known for its drawback of being very subjective and lacking precision. While infrared pupillometry devices such as OPD-Scan III and Sirius are available for accurately and reliably measuring pupil size. Nevertheless, the aforementioned equipments are costly and cumbersome to move in terms of screening and field trial logistics settings. And 2WIN-S is a portable refractor, it can in a short period of diopter and scotopic pupil size and other data obtained at the same time. Therefore, the aim of this study was to compare the agreement between 2WIN-S and OPD-Scan III in measuring scotopic pupil size and the repeatability of 2WIN-S.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

He Eye Hospital

Shenyang, Liaoning, 110001, China

About this study

Pupil diameter is a parameter of great interest in understanding brain systems and modern refractive surgery. Pupillometry, the measurement of variations in pupil dilation, has offered encouraging evidence for the involvement of disturbed reactivity in depression risk, according to studies. According to research, the pupil dilates in reaction to stimuli requiring a larger cognitive load or a greater emotional intensity. Importantly, studies have related pupil size variations to brain activity in regions associated with emotion regulation, including the dorsolateral prefrontal cortex (DPFC) and the agenesis of the corpus callosum (ACC) . Thus, pupillometry is proposed as a viable peripheral gauge for a variety of brain systems involved in the processing of emotional information.

Some of the postoperative complaints of patients having refractive corneal or lens surgery are related to visual quality and are associated with large pupils since optical aberrations become more dominant when the pupil dilates . If the pupil size exceeds the optical zone size, a marked increase in higher-order aberrations could be observed. Patients might complain about poor contrast sensitivity, increased glare disability, or halos. Precise measurement of scotopic pupil diameter has therefore become an essential step in the preoperative evaluation of patients suitable for refractive surgery and is an important inclusion or exclusion criterion.

This study aimed to assess the agreement and reproducibility of scotopic pupil size measurements using 2WIN-S compared with OPD-Scan III in Chinese adults.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years old
  • signed informed consent
  • willing to participate in the study

Exclusion criteria

Exclusion criteria

were ocular pathology known to interfere with pupillometer outcome and pupil abnormalities (eg: glaucoma, iritis, cataract, corneal scarring, any history of ocular surgery, and history of trauma.)

Treatment and study plan

2WIN-S

Device

Determining pupil diameter by 2WIN-S

OPD

Device

Determining pupil diameter by OPD

Primary outcomes

  1. Scotopic pupil size

    Time frame: 1 day

    Scotopic pupil size will be measured using 2WIN-S with OPD-Scan III.

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Official study title

Comparison of Two Pupillometer for Determining Pupil Diameter in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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