Clinical Evaluation of Correction Algorithm For Corvis ST Tonometry (Post)

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Clinical Evaluation of Correction Algorithm for Corvis ST Tonometry

Ahmed Elsheikh1,2, Akram Joda1; Kai-Jung Chen1;Riccardo Vinciguerra3; Paolo Vinciguerra3; Daniel Kook4; Shervin Sefat5; FangJun Bao6
1School of Engineering, University of Liverpool, Liverpool L69 3GH, UK
2National Institute for Health Research (NIHR) Biomedical Research Centre,
Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
3Eye Center, Humanitas Clinical and Research Center, Rozzano , Italy.
4Center of Refractive Therapy, Ludwig Maximilians University Munich, Munich, Germany
5Smile Eyes Private Eye Clinic, Munich, Germany
6Wenzhou Medical University, Wenzhou, China

Abstract Method (cont’d) Results (cont’d)


This study aims to develop and clinically evaluate a correction The study predictions of CVS-IOP and the input parameters of true
algorithm to improve the accuracy of intraocular pressure (IOP) IOP, CCT and age were used to develop IOP estimates that were
measurements made by the non-contact Corvis ST (CVS) less associated with the cornea’s stiffness parameters in an
tonometer, which considers the combined effects of variations in algorithm of the form (1):
central corneal thickness (CCT), age and the IOP level itself.
IOPcor = (CCCT1 x CCVS-IOP + CCCT2) x Cage + C (1)

Introduction where IOPcor is corrected IOP, CCCT1, CCCT2 represent the effect of
variation in CCT, CCVS-IOP represents effect of variation in measured
Accurate determination of IOP through tonometry is important for (a) (b) (C)
CVS-IOP, Cage denotes effect of variation in age, and C = 1.50
the effective management of glaucoma. Corvis ST (corneal Figure 2 Effectiveness of algorithm in reducing association of CVS-IOP with CCT for clinical
mmHg databases obtained from (a) Smile Eyes Clinics, Germany (b) Humanitas Clinical and Research
Visualization Scheimpflug Technology) is a non-contact tonometer Center, Italy and (c) Wenzhou Medical University, China
that has been developed by OCULUS Optikgeräte, Inc. (Wetzlar,
To evaluate the effectiveness of this algorithm, three independent
Germany). Corvis ST relies on high-precision, ultra-high-speed,
clinical databases were obtained from Smile Eyes Clinics (SEC),
Scheimpflug technology to monitor corneal deformation under air
Germany, Humanitas Clinical and Research Center (HCRC), Italy
puff and produce a wide range of tomography and deformation
and Wenzhou Medical University (WMU), China (Table 1) and used
parameters, which have the potential to enable consideration of
to provide estimates of IOP based on Equation1.
the effect of variation in corneal stiffness in providing accurate
estimates of the IOP.
All patients signed a written informed consent and the studies were
approved by their local institutional review boards and adhered to
In this study, numerical analysis based on the finite element
the tenets of the Declaration of Helsinki.
method has been conducted to quantity the effects of corneal
thickness and mechanical properties on the IOP measurements by
Table 1 Details of the clinical databases
the Corvis (CVS-IOP) [1]. The effectiveness of the resulting (a) (b) (C)
CSV-IOP
method in reducing the association of CVS-IOP with corneal Database Patients CCT (μm) Age (years)
(mmHg) Figure 3 Effectiveness of algorithm in reducing association of CVS-IOP with age for clinical
mechanical parameters was assessed using three independent Smile Eyes Clinics 632 537 ± 42 40 ± 12 14.5 ± 2.8
databases obtained from (a) Smile Eyes Clinics, Germany (b) Humanitas Clinical and Research
Center, Italy and (c) Wenzhou Medical University, China
clinical databases involving 632, 1047 and 99 patients.
Humanitas Clinical
1047 525 ± 38 46 ± 18 14.1 ± 3.5
and Research Center

Method Wenzhou Medical University 99 537 ± 30 29 ± 7 13.3 ± 2.1


Conclusions
The analysis relied on finite element models that simulate the Results The CVS correction algorithm considerably reduced the
human eye’s geometry and material behaviour, and the Corvis air dependence of CVS-IOP on CCT and age, addressing an
puff (Figure1). Models with variations in CCT, age and true IOP The correction algorithm was successful in significantly reducing
important error source in CVS-IOP measurements. The
were considered in a parametric study, and the results showed that the strength of association between CVS-IOP and CCT in the three
consistency in performance of the new algorithm over three
Phase 1
CCT was the dominant stiffness factor affecting CVS-IOP, followed datasets (Figure 2), from 0.0306 mmHg/μm (R2=0.204) to -0.0035
independent clinical databases indicates the suitability of the
by age, and that both CCT and age had a nonlinear (second order) mmHg/μm (R2=0.004) in the SEC set, from 0.0288 mmHg/μm
algorithm for clinical utility.
effect on the IOP measurements. (R2=0.095) to -0.009 mmHg/μm (R2=0.016) in the HCRC set and
from 0.033 mmHg/μm (R2=0.222) to 0.001 mmHg/μm (R2=00) in
the WMU set. References
[1] Joda et al. (2015) 'Development and Validation of a Correction Equation for
Moreover the association with age was weak in the three datasets CorVis ST Tonometry ', submitted to Computer Methods in Biomechanics and
(Figure 3), but still it was reduced with the application of the Biomedical Engineering.
algorithm from 0.024 mmHg/year (R2=0.0087) to 0.0043
mmHg/year (R2=0.0005) in the SEC set, from 0.0313 mmHg/year
For correspondence
(a) (b) (R2=0.0247) to -0.0167 mmHg/year (R2=0.0123) in the HCRC set Ahmed Elsheikh, PhD CEng
Figure 1 A finite element model of a human eye under the air pressure of Corvis ST (a)deformed and from -0.0544 mmHg/year (R2=0.0344) to -0.0508 mmHg/year Professor of Biomaterial Mechanics
mesh of the whole eye model and (b) Von mises stress distribution at the highest concavity elsheikh@liv.ac.uk
(R2=0.0324) in the WMU set.

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