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

Active, not recruiting

• Conditions: Zonule of Zinn Abnormality; Zonular Cataract
• Interventions: Device: ArcScan Insight 100 very high-frequency digital ultrasound

• Registration Number: NCT05657951
• Lead Sponsor: Wenzhou Medical University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-10-01
• Study First Submitted: 2022-11-29
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal eyes	ArcScan Insight 100 very high-frequency digital ultrasound	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Eye Hospital of WMU; 🇨🇳 Hangzhou, Zhejiang, China