Comparison of Two Different Pupillometer

NCT05717244 | Completed DMC

• 1 other identifier: 2WIN2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Measurement of Pupil Diameter

Keywords

2WIN-S; scotopic pupil size

Outcome Measures

Primary Outcomes (1)

• Scotopic pupil size

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

  1 day

Interventions

2WIN-S DEVICE

Determining pupil diameter by 2WIN-S

OPD DEVICE

Determining pupil diameter by OPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults attending ophthalmology clinic

You may qualify if:

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

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110001, China

Location

Related Publications (12)

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  PMID: 25280561 BACKGROUND

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  PMID: 21447417 BACKGROUND

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  PMID: 11297720 BACKGROUND

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  PMID: 15996878 BACKGROUND

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  PMID: 16624961 BACKGROUND

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  PMID: 2922323 BACKGROUND

• 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.

  PMID: 9715686 BACKGROUND

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  PMID: 12160815 BACKGROUND

• 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.

  PMID: 31567265 BACKGROUND

• 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.

  PMID: 27072310 BACKGROUND

• 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.

  PMID: 35901103 BACKGROUND

Study Officials

• Emmanuel E Pazo, MD, PhD

  He Eye Hospital, Shenyang, China

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 8, 2023
• Study Start: September 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: February 1, 2024
• Last Updated: June 24, 2024

Record last verified: 2023-02

Locations

CN (1)