Comparison of Two Different Pupillometer

Comparison of Two Pupillometer for Determining Pupil Diameter in Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Measurement of Pupil Diameter
• Intervention / Treatment: Device: OPD; Device: 2WIN-S

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • He Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

adults attending ophthalmology clinic

Description

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.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scotopic pupil size	Scotopic pupil size will be measured using 2WIN-S with OPD-Scan III.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
refraction	Refraction will be measured using 2WIN-S with ARK-1.	1 day

Collaborators and Investigators

• Sponsor: He Eye Hospital
• Investigators: Study Chair: Emmanuel E Pazo, MD, PhD, He Eye Hospital, Shenyang, China

Publications and helpful links

General Publications

• Couret D, Boumaza D, Grisotto C, Triglia T, Pellegrini L, Ocquidant P, Bruder NJ, Velly LJ. Reliability of standard pupillometry practice in neurocritical care: an observational, double-blinded study. Crit Care. 2016 Mar 13;20:99. doi: 10.1186/s13054-016-1239-z.
• Jones NP, Siegle GJ, Mandell D. Motivational and emotional influences on cognitive control in depression: A pupillometry study. Cogn Affect Behav Neurosci. 2015 Jun;15(2):263-75. doi: 10.3758/s13415-014-0323-6.
• Siegle GJ, Steinhauer SR, Friedman ES, Thompson WS, Thase ME. Remission prognosis for cognitive therapy for recurrent depression using the pupil: utility and neural correlates. Biol Psychiatry. 2011 Apr 15;69(8):726-33. doi: 10.1016/j.biopsych.2010.12.041.
• Siegle GJ, Granholm E, Ingram RE, Matt GE. Pupillary and reaction time measures of sustained processing of negative information in depression. Biol Psychiatry. 2001 Apr 1;49(7):624-36. doi: 10.1016/s0006-3223(00)01024-6.
• Siegle GJ, Steinhauer SR, Stenger VA, Konecky R, Carter CS. Use of concurrent pupil dilation assessment to inform interpretation and analysis of fMRI data. Neuroimage. 2003 Sep;20(1):114-24. doi: 10.1016/s1053-8119(03)00298-2.
• Critchley HD, Tang J, Glaser D, Butterworth B, Dolan RJ. Anterior cingulate activity during error and autonomic response. Neuroimage. 2005 Oct 1;27(4):885-95. doi: 10.1016/j.neuroimage.2005.05.047.
• Urry HL, van Reekum CM, Johnstone T, Kalin NH, Thurow ME, Schaefer HS, Jackson CA, Frye CJ, Greischar LL, Alexander AL, Davidson RJ. Amygdala and ventromedial prefrontal cortex are inversely coupled during regulation of negative affect and predict the diurnal pattern of cortisol secretion among older adults. J Neurosci. 2006 Apr 19;26(16):4415-25. doi: 10.1523/JNEUROSCI.3215-05.2006.
• Fardell J. Poverty and infant deaths. Nurs Times. 1989 Jan 11-17;85(2):18. No abstract available.
• Martinez CE, Applegate RA, Klyce SD, McDonald MB, Medina JP, Howland HC. Effect of pupillary dilation on corneal optical aberrations after photorefractive keratectomy. Arch Ophthalmol. 1998 Aug;116(8):1053-62. doi: 10.1001/archopht.116.8.1053.
• Rosen ES, Gore CL, Taylor D, Chitkara D, Howes F, Kowalewski E. Use of a digital infrared pupillometer to assess patient suitability for refractive surgery. J Cataract Refract Surg. 2002 Aug;28(8):1433-8. doi: 10.1016/s0886-3350(01)01350-5.
• Liu Q, Yang X, Lin L, Liu M, Lin H, Liu F, Xie Y, Lam DSC. Review on Centration, Astigmatic Axis Alignment, Pupil Size and Optical Zone in SMILE. Asia Pac J Ophthalmol (Phila). 2019 Sep-Oct;8(5):385-390. doi: 10.1097/01.APO.0000580144.22353.46.
• Nyholm B, Obling L, Hassager C, Grand J, Moller J, Othman M, Kondziella D, Kjaergaard J. Superior reproducibility and repeatability in automated quantitative pupillometry compared to standard manual assessment, and quantitative pupillary response parameters present high reliability in critically ill cardiac patients. PLoS One. 2022 Jul 28;17(7):e0272303. doi: 10.1371/journal.pone.0272303. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: 2WIN-S; scotopic pupil size
• Other Study ID Numbers: 2WIN2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No