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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
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.
London Vision Clinic
London, United Kingdom
Repeatability of ArcScan Insight 100 corneal scans in normal eyes (standard deviation)
The standard deviation of 5 repeated measurements for corneal thickness, epithelial thickness, and stromal thickness in normal eyes with no previous corneal surgery
Time frame: 1 day
Reproducibility of ArcScan Insight 100 corneal scans in normal eyes (between-operator standard deviation)
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
Time frame: 1 day
Repeatability of ArcScan Insight 100 anterior segment scans in normal eyes (standard deviation)
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
Time frame: 1 day
Reproducibility of ArcScan Insight 100 anterior segment scans in normal eyes (between-operator standard deviation)
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
Time frame: 1 day
Repeatability of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (standard deviation)
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
Time frame: 1 day
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Reproducibility of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (between-operator standard deviation)
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
Time frame: 1 day