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

NCT ID: NCT05657951

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Zonule of Zinn Abnormality Zonular Cataract

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Normal eyes

ArcScan Insight 100 very high-frequency digital ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye Hospital of WMU

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 33196325 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37300312 (View on PubMed)

Other Identifiers

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Insight100-zonule1

Identifier Type: -

Identifier Source: org_study_id