NCT02519985

Repeatability and Reproducibility of the ArcScan Insight 100 VHF Digital Ultrasound

Repeatability and Reproducibility of Corneal and Anterior Segment Measurements by ArcScan Insight 100 Very High-frequency Digital Ultrasound

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: London Vision Clinic · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Corneal Thickness Measurement
• Epithelial Thickness Measurement
• Anterior Eye Segment Measurements

Interventions

Type	Name	Description
DEVICE	ArcScan Insight 100 very high-frequency digital ultrasound	The ArcScan Insight 100 VHF digital ultrasound scanner that can measure individual layers within the cornea with very high precision, as well as being able to image the interior of the eye including the chamber between the iris and the cornea, the lens and other structures behind the iris. The ArcScan Insight 100 device is a digital ultrasound scanner, meaning that it uses ultrasound waves to measure parameters of the eye. The Insight examination involves the patient sitting in front of the ultrasound unit and looking through a disposable goggle-like eyepiece at a light source. Warm sterile balanced saline solution (like natural tears) are used to fill the space between the light source and the eye, to allow ultrasound transmission. There is no contact between the instrument and the eye other than being immersed in this water bath.

Timeline

• Start date: 2016-11-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2015-08-11
• Last updated: 2023-12-11

Locations

1 site across 1 country: United Kingdom