Topcon ALADDIN HW3.0, User Manual

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ALADDIN
- User manual Rev. 19 EN of 10/07/2019
158
16 PERFORMANCE TESTS
BRIEF SUMMARY OF PERFORMANCE TESTS AND RESULTS
A prospective, single site clinical study comparing the performance of the ALADDIN HW3.0 with LENSTAR LS
900 was conducted in 66 eyes (1 eye for each enrolled subject). This study evaluated the agreement and
precision in the subsequent endpoints:
Data Type All Devices
Quantitative
Measurements

Axial Length (AL)

Cylinder Axis (AX)

Anterior Chamber Depth (ACD)

Lens Thickness (LT)

Central Corneal Thickness (CCT)

White-to-white distance (WTW)

Keratometry at the flattest meridian (K1_D)

Keratometry at the steepest meridian (K2_D)
The related unit of measurements are:
-
Axial length: millimeters;
-
Cylinder Axis: degrees;
-
Anterior Chamber Depth: millimeters;
-
Lens Thickness: millimeters;
-
Central Corneal Thickness: millimeters;
-
White-to-white distance: millimeters;
-
Keratometry: diopters.
Analysis of Agreement
The measurements for the Agreement analysis arise from the first three acceptable measurement types
acquired from each device.
For each endpoint (AL, AX, ACD, LT, CCT, WTW, K1_D, K2_D), the analysis of agreement was performed for
every ALADDIN HW3.0 unit per LENSTAR LS 900 unit configuration for each operator separately.
The analysis was carried out estimating the mean difference, its standard deviation, 95% Limits of Agreement,
Bland-Altman scatter and difference plot using Bland-Altman method for multiple observations on an
individual (Bland and Altman, 1999).
The overall analysis of agreement is reported in the table below.
The endpoint means with their standard deviations were provided too.
Details about the Bland-Altman analysis: model terms were estimated via REML assuming exchangeable
replications and a device * subjects interaction term.
The agreement between instruments is summarized in Table 1: