NCT05717244|CompletedDMC
Comparison of Two Different Pupillometer
Comparison of Two Pupillometer for Determining Pupil Diameter in Healthy Participants
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Comparison of Two Pupillometer for Determining Pupil Diameter in Healthy Participants
Sponsor study identifier
observational
100
1 country
1
Study Start
September 1, 2023
Actual (reported)Primary Completion
December 20, 2023
Actual (reported)Study Completion
February 1, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 29, 2023
Actual (reported)February 8, 2023
Actual (reported)September 1, 2023
Actual (reported)December 20, 2023
Actual (reported)February 1, 2024
Actual (reported)Scotopic pupil size
Scotopic pupil size will be measured using 2WIN-S with OPD-Scan III.
1 day
Determining pupil diameter by 2WIN-S
Determining pupil diameter by OPD
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
adults attending ophthalmology clinic
He Eye Hospital
Shenyang, Liaoning, 110001, China
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.
Emmanuel E Pazo, MD, PhD
He Eye Hospital, Shenyang, China
100 participants (actual enrollment reported by the registry).
First Submitted
January 29, 2023
First Posted
February 8, 2023
Study Start
September 1, 2023
Actual (reported)Contact the study team to confirm eligibility.
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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.
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.
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.
Primary Completion
December 20, 2023
Actual (reported)Study Completion
February 1, 2024
Actual (reported)Last Updated
June 24, 2024
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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