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

Repeatability and Reproducibility of Lens Zonule Length Measurement Using ArcScan Insight 100 Very High-frequency Digital Ultrasound

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Zonule of Zinn Abnormality; Zonular Cataract
• Intervention / Treatment: Device: ArcScan Insight 100 very high-frequency digital ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 325027
      • Eye Hospital of WMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy subjects with no ocular disease except ametropia

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Normal eyes

Device: ArcScan Insight 100 very high-frequency digital ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability of zonule length measurement with the built-in software (the intraclass correlation)	After a 1-month period, operator A and operator B will measure the zonule length again. The intraclass correlation is used to evaluate the difference between the two repeated measurements of one same image by Operator A or Operator B.	1 month

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Insight100-zonule1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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