The Accuracy of Dynamic Contour Tonometry Over Soft Contact Lenses Fabrice Gogniat*, Daniela Steinegger*, Daniela S. Nosch†, Roland Joos‡, and Michael Goldschmidt§ ABSTRACT Purpose. Dynamic contour tonometry (DCT) has been shown to measure the intraocular pressure (IOP) independently of corneal thickness. This study aimed to investigate if DCT remains accurate when the IOP measurement is taken over soft contact lenses (CLs) of different thicknesses and material characteristics. Methods. This was a prospective clinical study that included 42 patients. Subject age was 22 to 59 years (26.5 T 6.3 years). Intraocular pressure and ocular pulse amplitude (OPA) measurements were taken under topical anesthesia without CLs and over various daily disposable CLs with j0.50, +5.00, and j5.00 diopters (D) in hydrogel (Nelfilcon A) and in silicone hydrogel (Narafilcon A) materials. Results. No statistically significant differences were found when comparing the IOP measurements obtained using either of the different CL powers ofj0.50 orj5.00 D, irrespective of which CL material was being used. However, the difference of 0.62mmHg observed when theNelfilcon Awith a power of +5.00Dwas used turned out to be highly statistically significant (p = 0.0002), whereas the Narafilcon Awith the same power of +5.00 D, with a small difference ofj0.16 mm Hg, was not. Regarding OPA measurements, no significant differences were found between measurements with and without CL neither for different materials nor for change in dioptrical power (F = 0, p = 1.000). Conclusions. This study showed good reliability of IOP and OPA measurements over CLs with varying thickness profiles and different soft materials when using theDCT.Only a small but statistically significant difference of 0.62mmHgwas found for the IOP measurement with the hydrogel CL of +5.00 D compared with ‘‘no CL.’’ (Optom Vis Sci 2013;90:125Y130) Key Words: dynamic contour tonometer, cornea, intraocular pressure, ocular pulse amplitude, topical anesthesia, hydrogel, silicone hydrogel, contact lens Goldmann applanation tonometry has long been consid-ered to represent the gold standard for intraocular pres-sure (IOP) measurement.1,2 Its underlying principle is to estimate the necessary force to flatten the central corneal area within a diameter of 3.06 mm. Unfortunately, this makes IOP measure- ments dependent on corneal properties, such as thickness, rigidity, curvature, and axial length.3Y6 It is calibrated for a central corneal thickness of 520 Km and hence overestimates the IOP of eyes with thicker corneas and underestimates the IOP of eyes with thinner corneas.5 Furthermore, there are practical challenges during IOP measurement when using traditional Goldmann applanation to- nometry, such as aligning the two prism mires accurately. The dynamic contour tonometer ([DCT] Ziemer Ophthalmic Systems, Port, Switzerland) is believed to be largely independent of corneal properties. Boehm et al.7 compared DCT readings with intracameral IOP measurements and found the DCT measure- ments to be accurate. In certain clinical situations, it may be advantageous or indeed necessary to measure the IOP over a contact lens (CL) in situ. Obviously, the use of anesthetic drops can be avoided. It is also helpful in cases where the patient is wearing a bandage CL because lens removal may impair corneal epithelial healing. For eyes with corneal pathology such as bullous keratopathy, abrasions, and ulcers, a lens can serve as a buffer and hence protect the cornea during the IOP measurement. In some countries (such as those of continental Europe), optometrists are not registered to use diag- nostic drugs. Several studies have already shown the IOP measurements to be accurate over soft CLs using various other tonometry methods, and they have been discussed previously.8 Using the DCT, IOP measurements have been shown to remain accurate if they were 1040-5488/13/9002-0125/0 VOL. 90, NO. 2, PP. 125Y130 OPTOMETRY AND VISION SCIENCE Copyright * 2013 American Academy of Optometry ORIGINAL ARTICLE Optometry and Vision Science, Vol. 90, No. 2, February 2013 *BSc †MSc, MCOptom ‡PhD §OD University of Applied Sciences Northwest of Switzerland, Institute of Op- tometry, Olten, Switzerland. Copyright © American Academy of Optometry. Unauthorized reproduction of this article is prohibited. carried out over a thin daily disposable hydrogel CL (j0.50 di- opters [D]; Filcon IV) on normal corneas with regular topo- graphic maps.8 Because the DCT takes a different approach to measure IOP, it was considered interesting to explore the effect of the CL thickness profile and its rigidity on the accuracy of its measurements. The aim of this study was to determine the reliability of the DCT over soft daily disposable CLs of different dioptric powers and different soft materials (hydrogel and silicone hydrogel). The Dynamic Contour Tonometer The underlying principles of the DCT have been previously explained elsewhere.8,9 Briefly, the DCT has a specifically designed tip with a concave contact surface that matches the contour of the cornea and hence allows the cornea to assume the shape that it naturally assumes when the IOP is equal to the transverse pressure applied to its anterior surface and its distortion is minimal. A digital pressure sensor integrated in the DCT contoured surface allows a direct IOP measurement across the cornea. Correct positioning of the tip is indicated by an audible signal that changes in pitch with detected variations in pressures. The tip generates an electric sig- nal that is proportional to the IOP level. Rhythmic oscillations corresponding to the pressure signal are detected during 6 to 10 heartbeats. The IOP is calculated automatically and displayed on a digital liquid crystal screen. The quality score of the measurements ranges from excellent (score of 1) to poor (score of 4 or 5) and is simultaneously displayed on the screen. The main advantage of the DCT is its ability to measure IOP independently of physiologic variables such as corneal thickness, corneal radius, astigmatism, and corneal rigidity. Hence, IOP does not need to be corrected for particularly thin or thick corneas. The Ocular Pulse Amplitude The DCT also measures the ocular pulse amplitude (OPA). Its value is expressed in millimeters mercury. The mean value for a normal OPA value is 3 mm Hg, with a mean difference of 0.4 mm Hg between the two eyes. It represents the difference between the mean systolic IOP and mean diastolic IOP.10 The pulsatile character of the IOP is thought to be caused by the blood volume that is pumped into the eye with each cardiac cycle. In this way, these pulsations might reflect the ocular blood flow.11Y13 During the past decades, evidence has grown that vascular factors also contribute to the pathogenesis of glaucoma, and hence, the measurement of OPA may help in monitoring the clinical course of glaucoma.11,13Y18 METHODS This was a prospective clinical study, which included 42 white patients (21 right and 21 left eyes), of which 26 were female. The age varied from 22 to 59 years (mean, 26.5 T 6.3 years). The inclusion criteria were corneas with a regular topographical shape (i.e., no degeneration or dystrophy affecting corneal thickness or shape) and no presence of ocular pathology (assessed by slit lamp examination). All participants were volunteers from the University of Applied Sciences in Olten. They signed an informed consent, which also included a comprehensive explanation of possible adverse events of topical anesthesia. Two clinicians were taking measurements (D.S. and F.G.). To exclude any effect of patient anxiety resulting from the first IOP measurement, three additional IOP measurements were carried out with a noncontact tonometer (Nidek NT-530) and two additional DCT measure- ments were carried out beforehand that were not included for analysis. The following different dioptric powers for the CLs were used: j0.50, +5.00, and j5.00 D. Two different soft materials were used: one hydrogel (Nelfilcon A, CIBA VISION/Alcon) and one silicone hydrogel (Narafilcon A, Johnson, Johnson & Vision Care). One published study showed a small effect of topical an- esthesia on IOP.19 It was therefore decided to cancel out any possible effects this may produce by applying the topical anesthetic oxybuprocaine 0.4% SDU Faure every 15 minutes during the duration of the experiment. This means that if there was a bias caused by anesthesia, it would have been present in all measure- ments and therefore can be neglected as far as measurements with and without CLs are compared. In the event of adverse reactions, the trial would have been aborted and the patient would have been sent to the nearby eye hospital. All subjects enrolled for this study completed their study participation and could be included for statistical analysis. One drop of oxybuprocaine 0.4% SDUFaure was instilled in the examined eye. After the three preliminary noncontact tonometer measurements and the two preliminary DCT measurements, IOP and OPA measurements were carried out with ‘‘no CL’’ and six different CLs as specified above. The order of all measurements, the choice of right or left eye, and the examiner (F.G. or D.S.) were randomized and balanced. Onlymeasurements of high-quality level of 1 or 2 (out of 5 levels) were included for analysis. If an inferior quality appeared, the measurement was repeated until the necessary quality was achieved. This study was conducted in accordance with the ethical commission of Aargau, Switzerland. During the course of a pilot study in preparation of this clinical study, interobserver reliability between the two examiners F.G. and D.S. was measured. This was done by looking at Bland-Altman plots and estimating the confidence limits of the measurements on 14 eyes. No clinically significant difference, neither for IOP nor for OPA, could be found. The IOP and OPA measurements could hence be considered to be independent of the examiners. Statistical Analysis All statistical analysis was carried out using the statistical soft- ware R.20 A power calculation was applied to detect a difference of 0.75 mm Hg, with an SD of 1.11, > = 0.05 and 1-A = 0.8, which determined a minimum number of 35 subjects. From the pilot study mentioned before, the SD was estimated with a confidence interval of 1.03 to 1.18 mm Hg and a mean of 1.11 mm Hg. The value 0.75 mm Hg was adopted as a clinically significant differ- ence because this amount represents one-half of the value of the SD of DCT. For these conditions, a sample size of 32, 35, and 40, respectively, was calculated. With respect to this and for a better balanced statistical analysis, it was decided to enroll 42 subjects for this clinical study. A linear mixed-effects model was used, which has been shown to be appropriate for this kind of correlated data.21 In the linear mixed-effects models, either IOP or OPA was 126 Dynamic Contour Tonometry Over Soft Contact LensesVGogniat et al. Optometry and Vision Science, Vol. 90, No. 2, February 2013 Copyright © American Academy of Optometry. Unauthorized reproduction of this article is prohibited. the dependent variable. Candidates for fixed factors in the model- building process were a combination of lens power and lens type called ‘‘power lens type’’ (PLT), a factor with seven levels (i.e., ‘‘no CL,’’ Nelfilcon A,j5.00D,j0.50D, and +5.00 D;Narafilcon A, j5.00 D, j0.50 D, and +5.00 D), sex, age, investigator, and test sequence (14 different test sequences had been defined to get a balanced design). Test subjects were treated as random factors. The model- building process was started by including all measured possible factors. Model reduction was aided by applying StepAIC from package MASS, by which nonsignificant variables could be elimi- nated one after another.22 Each factor eliminated was further shown to be not significant by an appropriate F test. Diagnostic plots and a Shapiro-Wilk test were applied to examine if the measurement error distribution showed normal distribution. As a result of this procedure, an ordinary regression table was obtained, showing which factors are statistically significant. The model’s covariance matrix was used to estimate intervals of con- fidence; where appropriate Bonferroni correction for multiple comparisons was applied. RESULTS The results obtained for IOP andOPAwere compared in relation to the different dioptric CL powers (j0.50,j5.00, and +5.00 D) and the two soft CL materials (Nelfilcon A and Narafilcon A) used for this study, summarized by the factor PLT. Table 1 shows the mean values and SDs obtained for IOP and OPA for the overall group of subjects, and Table 2 shows the mean values for individual material and power combinations. In this study, all mean OPA values were lowerwithout andwith variousCLmaterials and powers tested than the 3 mm Hg one would normally expect. To keep the presentation of results concise, only one linear fixed model is being discussed in more detail. First, the reduction of nonsignificant factors leads to a model where only one fixed effect term remained, that is, the PLT. The analysis of variance table of this model shows that besides the constant term, this factor was highly significant (F540 = 6.0; p G 0.0001). From this, it could be concluded that thematerial and power combination was statistically significant. In the regression table for this model (Table 3), the combination of ‘‘Power 0 D’’ and ‘‘no CL’’ serves as a baseline and is represented in the ‘‘Intercept’’ term. Further differences for other PLTs with respect to this reference value are listed in Table 3, along with SEs, number of degrees of freedom, and p value. As this table contains multiple comparisons, the significance level was corrected by the method of Bonferroni; as there are six comparisons, sig- nificance level was lowered to 0.05/6 = 0.00833 (Table 4). The Effect of CL Power and Material on IOP Figs. 1 and 2 show that the IOP values obtained with different lens powers and materials were very similar. Table 3 shows that no statistically significant differences were found when comparing the IOP measurements obtained using either of the different CL powers ofj0.50 andj5.00 D, irrespective of which CL material was being used. However, the difference of 0.62 mm Hg observed when the Nelfilcon A with a power of +5.00 D was used turned out to be highly statistically significant (p = 0.0002), whereas the Narafilcon A with the same power of +5.00 D with a small dif- ference of j0.16 mm Hg was not. The Effect of CL Power and Material on OPA Fig. 3 shows very little difference for any OPA measurements for neither lens power nor CL material. The OPA values were not influenced by any CL power or material used in this study: no TABLE 1. Means and SDs for IOP and OPA for the overall group without CL Mean value and SD, mm Hg IOP 15.08 T 2.10 OPA 2.05 T 0.69 TABLE 2. Means and SDs for the IOP and OPA for different materials and powers CL material Power, D Mean IOP and SD, mm Hg Mean OPA and SD, mm Hg None 0.00 15.08 T 2.10 2.05 T 0.69 Nelfilcon A j5.00 14.91 T 1.77 2.05 T 0.68 j0.50 15.20 T 2.11 1.99 T 0.77 +5.00 15.71 T 2.08 2.04 T 0.67 Narafilcon A j5.00 14.95 T 2.22 2.00 T 0.72 j0.50 14.98 T 1.92 2.01 T 0.69 +5.00 14.93 T 2.18 2.03 T 0.69 TABLE 3. Regression table for the linear mixed-effects model Term Value, mm Hg SE, mm Hg df t p Intercept 15.08 0.31 540 48.97 0.0000 Nelfilcon A, j0.50 D 0.11 0.17 540 0.67 0.5030 Nelfilcon A, j5.00 D j0.18 0.17 540 j1.06 0.2886 Nelfilcon A, +5.00 D 0.62 0.17 540 3.73 0.0002 Narafilcon A, j0.50 D j0.11 0.17 540 j0.63 0.5260 Narafilcon A, j5.00 D j0.14 0.17 540 j0.83 0.4086 Narafilcon A, +5.00 D j0.16 0.17 540 j0.95 0.3434 TABLE 4. Confidence intervals for various lens type and lens power combinations Comparison Lower, mm Hg Estimate, mm Hg Upper, mm Hg No CL vs. Nelfilcon A,j0.50 D j0.33 0.11 0.55 No CL vs. Nelfilcon A,j5.00 D j0.62 j0.18 0.26 No CL vs. Nelfilcon A, +5.00 D 0.18 0.62 1.06 NoCLvs.NarafilconA,j0.50D j0.55 j0.11 0.33 NoCLvs.NarafilconA,j5.00D j0.58 j0.14 0.30 NoCL vs. Narafilcon A, +5.00D j0.60 j0.16 0.28 Confidence levels are 1-0.05/6, accounting for multiple com- parisons (Bonferroni). Dynamic Contour Tonometry Over Soft Contact LensesVGogniat et al. 127 Optometry and Vision Science, Vol. 90, No. 2, February 2013 Copyright © American Academy of Optometry. Unauthorized reproduction of this article is prohibited. FIGURE 1. Box plots representing IOP measurements for each lens power. FIGURE 2. Box plots representing IOP measurements dependent on lens power and CL material. 128 Dynamic Contour Tonometry Over Soft Contact LensesVGogniat et al. Optometry and Vision Science, Vol. 90, No. 2, February 2013 Copyright © American Academy of Optometry. Unauthorized reproduction of this article is prohibited. significant dependency of the OPA from the lens-type power- variable PLT (F = 0, p = 1.000) was obtained by the linear mixed- effects model. DISCUSSION For this study, the reliability of the DCT was evaluated when IOP and OPA measurements were carried out over CLs with various thickness profiles (different dioptric powers) and different soft materials (hydrogel and silicone hydrogel). Our results showed that the reliability of IOP and OPA mea- surements over CLs with varying thickness profiles and different soft materials remained good. Only a small but statistically sig- nificant difference was found for the IOP measurement with the hydrogel CL of +5.00 D (Nelfilcon A). One possible explanation for this finding could be that the silicone hydrogel material may have provided the DCT sensor tip a more stable surface for its measurement because it has a higher elasticity modulus than the hydrogel material and consequently is stiffer. It is also possible that the hydrogel CL of +5.00 D had in fact a higher center thickness than its silicone hydrogel counterpart, which could have given rise to a higher IOP value in itself. However, this would also mean that the DCT’s ability to measure independently of thickness would have to be questioned. Clearly, further studies are required to investigate this issue in more detail. To cancel out any possible additional effects the topical anes- thesia itself could have had on any IOP or OPA results, the in- stillation of oxybuprocaine was repeated every 15 minutes for the period during which DCT measurements were carried out for the purpose of this study. This means that if there was a bias caused by anesthesia, it would have been present in all measurements and therefore can be neglected as far as measurements with and without CLs are compared. Interestingly, the mean values for OPA obtained in this study were lower than the expected 3 mm Hg, irrespective of the CL material or power or if a CL was worn at all. There has been some suggestion for a negative correlation between OPA and axial length,23Y25 but unfortunately, the refractive status was not re- corded for the subjects participating in this study. Hence, this finding could unfortunately not be further explored. CONCLUSIONS This study showed good reliability of IOP and OPA mea- surements over CLs with varying thickness profiles and different soft materials when using the DCT. No statistically significant difference was found for the IOP measurement when using daily disposable silicone hydrogel CLs of either power used in this study. A small but statistically significant difference of 0.62 mm Hg (p = 0.0002) however was noted when using the daily FIGURE 3. Box plots representing OPA measurements dependent on lens power and CL material. Dynamic Contour Tonometry Over Soft Contact LensesVGogniat et al. 129 Optometry and Vision Science, Vol. 90, No. 2, February 2013 Copyright © American Academy of Optometry. Unauthorized reproduction of this article is prohibited. disposable hydrogel CL of +5.00 D. Nevertheless, this difference would not be considered to be of clinical relevance. Regarding OPA, no significant difference was found for any power or mate- rial of any CL used for this study. In other words, in this study,OPA measurements were not affected by CL power or CL material. ACKNOWLEDGMENTS None of the authors have any financial or personal relationships with the manufacturer of the DCT used in this study. All authors declare that there is no conflict of interest. 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Acta Ophthalmol 2011;89:466Y71. Daniela S. Nosch Institut fu¨r Optometrie Fachhochschule Nordwestschweiz Aarauerstrasse 30 4600 Olten, Schweiz e-mail: daniela.nosch@fhnw.ch 130 Dynamic Contour Tonometry Over Soft Contact LensesVGogniat et al. Optometry and Vision Science, Vol. 90, No. 2, February 2013 Copyright © American Academy of Optometry. Unauthorized reproduction of this article is prohibited.