Accuracy of a Freezing Point Depression Technique Osmometer.

PURPOSE: The purpose of this study was to examine the precision and accuracy of the Fiske 110 Osmolarity System under different protocols to determine the possible applications of this device in tear film research and clinical practice. METHODS: Three separate studies were performed. In the first, Fiske 110 measurements were made on undiluted and diluted (1:1, 1:4, and 1:9 dilutions) standard samples of different osmolarity values: 50, 290, and 850 mOsm/kg and 297 and 338 mOsm/L. In the second study, measurements were made on different types of contact lens care solutions. Finally, in an agreement study, measurements were made in two sets of 60 subjects to compare TearLab versus Fiske 110 (using both 2- and 4-µL tear sample). RESULTS: Although osmolarity measurements for undiluted solutions differed statistically from reference standard values, all biases were in the tolerance range proposed by the manufacturer except for the 850-mOsm/kg solution. No significant differences from reference osmolarity values were observed for the 1:1 and 1:4 diluted 297- and 338-mOsm/L H2O solutions, respectively, although all diluted solutions showed a possible bias out of the range provided. Osmolarities for the soft contact lens solutions fell within the range 293 to 309 mOsm/kg with the exception of Opti-Free Express (225 mOsm/kg). In the agreement study, significant differences were observed between measurements obtained using the TearLab and both Fiske 110 procedures, although the Fiske 110 (4 µL) procedure was closer to the TearLab than the Fiske (2 µL) procedure. CONCLUSIONS: For undiluted solutions, the Fiske 110 shows good performance, making it a useful device for osmolarity measurements in lens care solutions or eye drops. A worse performance was observed for more diluted standard solution samples. When testing diluted samples, performance was acceptable for osmolarity values close to tear values.

Interobserver and intraobserver repeatability of lipid layer pattern evaluation by two experienced observers.

PURPOSE: The lipid layer plays a major role in limiting evaporation of the tear film. Based on interference phenomena, there is a test directed to lipid layer pattern (LLP) evaluation, but is affected by subjective interpretation of the patterns. The aim of this study is to compare the LLP evaluation between two experienced observers on a group of healthy patients. Furthermore, observers re-evaluated the same images to check their individual repeatability. MATERIALS AND METHODS: LLP was examined using a Tearscope-plus (Keeler, Windsor, UK) attached to a slit lamp. Tear film was recorded by a Topcon DV-3 digital camera video and LLP images were captured. This yielded 124 LLP images that were categorized (based on Guillon's scheme) by two expert observers in two sessions separated by one month. Interobserver repeatability and intraobserver repeatability between both sessions were studied by using Cohen's kappa coefficient. RESULTS: Comparing LLP categorization between both observers, Cohen's kappa coefficient was 0.615 and 0.633 for first and second session, respectively. When comparing LLP categorization by the same observer between both sessions, Cohen's kappa coefficient was 0.770 and 0.812 for Observer 1 and Observer 2, respectively. These results indicate substantial correlation in all cases. The most frequent misinterpretations were between open and closed meshwork and Wave and closed meshwork patterns. CONCLUSION: Although substantial correlation was found between categorizations of experienced observers, misinterpretation of the patterns may appear even in the same observer. Some misinterpretations between adjacent patterns could be palliated by including intermediate patterns between those categories.

Reliability of the non-contact tono-pachymeter Tonopachy NT-530P in healthy eyes.

BACKGROUND: Non-contact Tonopachy NT-530P (Nidek Co., LTD) provides intraocular pressure (IOP) and central corneal thickness (CCT) measurements. This study assesses the reliability and repeatability of its IOP measurements in young healthy adult subjects. METHODS: IOP was determined in the right eye of 64 healthy patients using Tonopachy followed by the Canon TX-10 non-contact and Goldmann applanation (GAT) tonometers. Tonopachy IOP measurements were corrected (Tonopachy-C) or not (Tonopachy-NC) by the instrument for central corneal thickness. Central corneal thickness measurements provided by Tonopachy were also used to correlate (Pearson's coefficient) central corneal thickness with the GAT and Canon TX-10 IOPs. Repeatability of Tonopachy and GAT was assessed in the right eye of 31 subjects in two separate sessions one week apart. Differences between pairs of instruments and between sessions were determined using Bland-Altman plots. The coefficient of repeatability was calculated as the 95% limits of agreement (LoA) of differences between the two sessions. RESULTS: Tonopachy-NC, Tonopachy-C, Canon TX-10 and the Goldmann tonometers showed a mean IOP of 14.62, 15.64, 15.02 and 14.68 mmHg, respectively. Tonopachy-NC and Canon TX-10 readings did not differ significantly from the Goldmann (p > 0.05), with close agreement with both tonometers (GAT versus Tonopachy-NC: -3.84 to 3.96 mmHg; Goldmann versus Canon TX-10: -4.75 to 4.07 mmHg). Tonopachy-C readings differed significantly from Goldmann (mean difference -0.96 mmHg, p = 0.001, LoA from -5.09 to 3.17). Coefficients of repeatability were ± 3.70, ± 3.14 and ± 3.33 mmHg for GAT, Tonopachy-NC and Tonopachy-C, respectively. Central corneal thickness measured with Tonopachy was 530.42 ± 34.96 µm. There was a significant correlation between central corneal thickness and IOP for all tonometers except Tonopachy-C. CONCLUSIONS: Reasonable agreement was observed between the Goldmann and Tonopachy. This instrument provides reliable and repeatable IOP measurements not influenced by central corneal thickness. The Tonopachy-NC and Canon TX-10 offer similar reliability compared to the Goldmann applanation tonometer in a young normotensive population.

Accuracy and repeatability of a new tono-pachymeter for measuring central corneal thickness.

OBJECTIVES: The recently developed noncontact tonopachymeter Tonopachy NT-530 P provides intraocular pressure values corrected for central corneal thickness (CCT). The purpose of this study was to assess the accuracy and repeatability of its CCT measurements. METHODS: The CCT measurements were obtained in 64 right eyes of 64 young healthy subjects using the Orbscan corneal topography system followed by the Tonopachy and then by ultrasound pachymetry (UP). Another sample of 31 subjects was used to test the repeatability of the tonopachy measurements in 2 separate sessions 1 week apart. To compare the tonometers and determine intersession repeatability for the tonopachymeter, differences in the readings provided by pairs of the instruments or obtained in the two sessions were plotted against mean differences. The hypothesis of zero bias was examined by a paired t-test. The coefficient of repeatability was calculated as the 95% limits of agreement (LoAs) of differences between the 2 sessions. RESULTS: Measurements made using the three instruments were significantly correlated (P<0.001). Mean CCTs (±SD) measured using the Tonopachy, Orbscan (acoustic factor set at 0.92) and ultrasound pachymeter were 530.42 ± 34.96, 526.73 ± 39.53, and 550.69 ± 37.26 µm, respectively. The differences between modalities (±95% LoAs) were -3.68 ± 24.36 for Orbscan versus Tonopachy, 20.66 ± 14.69 for UP versus Tonopachy, and 23.95 ± 24.21 for UP versus Orbscan. The coefficient of repeatability for the tonopachymeter was ±15.11 µm. CONCLUSIONS: The Tonopachy offers similar CCT measurements to those provided by conventional pachymeters with good repeatability.