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

Sponsor

Wenzhou Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05657951

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Zonule of Zinn Abnormality Zonular Cataract	Device: ArcScan Insight 100 very high-frequency digital ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Actual Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Repeatability of ArcScan Insight 100 zonule scans in normal eyes (standard deviation and coefficient of variation) [1 day]
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.
Reproducibility of ArcScan Insight 100 zonule scans in normal eyes [1 day]
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.

Secondary Outcome Measures

Repeatability of zonule length measurement with the built-in software (the intraclass correlation) [1 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hospital of WMU	Hangzhou	Zhejiang	China	325027

Sponsors and Collaborators

Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Yune Zhao, Vice president, Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT05657951

Other Study ID Numbers:

Insight100-zonule1

First Posted:

Dec 20, 2022

Last Update Posted:

Dec 20, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Dec 20, 2022