Repeatability and Reproducibility of the ArcScan Insight 100 VHF Digital Ultrasound

Not Applicable

Suspended

• Conditions: Epithelial Thickness Measurement; Anterior Eye Segment Measurements; Corneal Thickness Measurement
• Interventions: Device: ArcScan Insight 100 very high-frequency digital ultrasound

• Registration Number: NCT02519985
• Lead Sponsor: London Vision Clinic

Brief Summary

The purpose of this study is to evaluate the repeatability and reproducibility of corneal (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment measurements using the ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.

Detailed Description

Very high-frequency (VHF) digital ultrasound was first used in 1993 to obtain images of the cornea (the window at the front of the eye) and anterior segment (the space behind the cornea including the iris and the lens). A commercially available instrument, called the Artemis 2, has been used in routine clinical practice since 2001. The Artemis 2 was CE approved as well as having FDA approval (the US equivalent of the CE mark).

The ArcScan Insight 100 VHF digital ultrasound scanner is a new instrument so does not yet have a CE mark. However, the ArcScan Insight 100 is an upgraded version of the Artemis 2, so any differences are improvements to components, but the measurement method remains essentially the same.

The aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) of the ArcScan Insight 100 device for measuring corneal and anterior segment parameters.

Study Timeline

• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-11
• Study Start: 2016-11-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Repeatability and Reproducibility of ArcScan Insight 100	ArcScan Insight 100 very high-frequency digital ultrasound	For repeatability and reproducibility in normal eyes (n=20): Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the first operator. After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the second operator. For repeatability and reproducibility in eyes after laser refractive surgery (n=20): Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the first operator. After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the second operator.

Primary Outcome Measures

Name	Time	Method
Repeatability of ArcScan Insight 100 corneal scans in normal eyes (standard deviation)	1 day	The standard deviation of 5 repeated measurements for corneal thickness, epithelial thickness, and stromal thickness in normal eyes with no previous corneal surgery

Secondary Outcome Measures

Name	Time	Method
Repeatability of ArcScan Insight 100 anterior segment scans in normal eyes (standard deviation)	1 day	The standard deviation of 5 repeated measurements for anterior segment dimensions: angle diameter, sulcus diameter, anterior chamber depth, and lens rise from the zonular plane in normal eyes with no previous corneal surgery
Reproducibility of ArcScan Insight 100 anterior segment scans in normal eyes (between-operator standard deviation)	1 day	The between-operator standard deviation of 5 repeated measurements for each operator for anterior segment dimensions: angle diameter, sulcus diameter, anterior chamber depth, and lens rise from the zonular plane in normal eyes with no previous corneal surgery
Reproducibility of ArcScan Insight 100 corneal scans in normal eyes (between-operator standard deviation)	1 day	The between-operator standard deviation of 5 repeated measurements for each operator for corneal thickness, epithelial thickness, and stromal thickness in normal eyes with no previous corneal surgery
Reproducibility of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (between-operator standard deviation)	1 day	The between-operator standard deviation of 5 repeated measurements for each operator for corneal thickness, epithelial thickness, stromal thickness, flap thickness, and residual stromal thickness in eyes after corneal laser refractive surgery
Repeatability of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (standard deviation)	1 day	The standard deviation of 5 repeated measurements for corneal thickness, epithelial thickness, stromal thickness, flap thickness, and residual stromal thickness in eyes after corneal laser refractive surgery

Trial Locations

Locations (1)

London Vision Clinic; 🇬🇧 London, United Kingdom