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Status unknownNCT05657951Updated Dec 20, 2022

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

An observational study in Zonule of Zinn Abnormality and Zonular Cataract, sponsored by Wenzhou Medical University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-12-20.

Sponsored by Wenzhou Medical University · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
45
Sex
All
01

Study 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).

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Conditions studied

  • Zonule of Zinn Abnormality
  • Zonular Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 45 is below the median of 81 across 484 observational studies indexed under Cataract.

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Lead sponsor

Wenzhou Medical University is the lead sponsor of 93 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy subjects with no ocular disease except ametropia

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
45 participants (estimated)
Patient registry
No

Groups and cohorts

  • Normal eyes

    Device: ArcScan Insight 100 very high-frequency digital ultrasound

Interventions

  • DeviceArcScan 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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.

    Time frame: 1 month

07

Study locations

1 site
  • Eye Hospital of WMU
    Hangzhou, Zhejiang 325027, China
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References and documents

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. PubMed 33196325 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05657951
Lead sponsor
Wenzhou Medical University
Responsible party
Yune Zhao (Vice president, Wenzhou Medical University) — Principal investigator
First posted
Dec 20, 2022
Start date
Aug 1, 2022
Primary completion
Oct 1, 2022
Completion
Dec 31, 2022 (estimated)
Last update
Dec 20, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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