Repeatability and Reproducibility of Lens Zonule Length Measurement Using ArcScan Insight 100

NCT05657951 | Unknown

• 1 other identifier: Insight100-zonule1
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the intra-examiner repeatability and inter-examiner reproducibility in lens zonule length measurements using very high-frequency (VHF) digital ultrasound (ArcScan Insight 100).

Conditions

Zonule of Zinn Abnormality; Zonular Cataract

Outcome Measures

Primary Outcomes (2)

• Repeatability of ArcScan Insight 100 zonule scans in normal eyes (standard deviation and coefficient of variation)

  First, three images will be obtained under'capsule model'using ArcScan Insight 100, and the length of zonule will be measured with built-in software by operator A. Operator B then performed the measurements using the same procedure and technique. The standard deviation and coefficient of variation of 3 repeated measurements for zonule length. will be calculated.

  1 day

• Reproducibility of ArcScan Insight 100 zonule scans in normal eyes

  First, three images will be obtained under'capsule model'using ArcScan Insight 100, and the length of zonule will be measured with built-in software by operator A. Operator B then performed the measurements using the same procedure and technique. The intraclass correlation is used to evaluate the difference between operator A and operator B.

  1 day

Secondary Outcomes (1)

• Repeatability of zonule length measurement with the built-in software (the intraclass correlation)

  1 month

Study Arms (1)

Normal eyes

Device: ArcScan Insight 100 very high-frequency digital ultrasound

Interventions

ArcScan Insight 100 very high-frequency digital ultrasound DEVICE

The Insight-100 (ArcScan Inc., Golden, CO, USA) employs the high-frequency B-scan in the assessment of anterior segment parameters. Anormal saline coupling medium is formed with a disposable eyepiece between the 50 MHz transducer and the eye. The instrument moves the transducer in an arc so that the beam axis maintains approximate normality to the surface of the eye. The frequencies of cornea, anterior chamber, and lens are 60 MHz, 50 MHz and 50 MHz, respectively. The maximum arc scanning range is 70 degrees, and there is a linear scanning range of 29mm. The axial and lateral resolutions are 35 μm and 65 μm, respectively. It can measure structures behind the iris, including lens zonule.

Normal eyes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy subjects with no ocular disease except ametropia

You may qualify if:

• Subjects with no ocular disease except ametropia
• Subjects will be able to understand and willing to sign an informed consent

You may not qualify if:

• Previous ocular surgery
• Subjects not being able to tolerate or not willing to use pilocarpine eye drops
• Subjects has active ocular infection or inflammation
• Subjects not being able to look steadily
• Subjects not being able to open eyes wide in sterile saline even after topical anesthesia

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Eye Hospital of WMU

Hangzhou, Zhejiang, 325027, China

Location

Related Publications (2)

• Li X, Chang P, Li Z, Qian S, Zhu Z, Wang Q, Yun-E Z. Agreement between anterior segment parameters obtained by a new ultrasound biomicroscopy and a swept-source fourier-domain anterior segment optical coherence tomography. Expert Rev Med Devices. 2020 Dec;17(12):1333-1340. doi: 10.1080/17434440.2020.1848541. Epub 2020 Dec 1.

  PMID: 33196325 BACKGROUND

• Zhu Z, Zou H, Li H, Wu X, Wang Y, Li Z, Zhao Y. Repeatability and reproducibility of anterior lens zonule length measurement using ArcScan insight 100 very high-frequency ultrasound. Expert Rev Med Devices. 2023 Jul-Dec;20(8):703-710. doi: 10.1080/17434440.2023.2223967. Epub 2023 Jun 13.

  PMID: 37300312 DERIVED

MeSH Terms

Conditions

Cataract, zonular

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 20, 2022
• Study Start: August 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)