Within-subject Standard Deviation Research Articles

Development and psychometric properties of the Functional Assessment of Cancer Therapy-Cutaneous T-Cell Lymphoma (FACT-CTCL).

Patients with Mycosis Fungoides (MF)/Sézary Syndrome (SS) can experience impacted health-related quality of life (HRQoL). To validate the CTCL-S, a novel subscale of the Functional Assessment of Cancer Therapy - General (FACT-G), in patients with MF/SS. Qualitative interviews were conducted with expert clinicians and MF/SS patients. Thematic analysis identified the most common concerns, and 19 items were selected.MF/SS patients were recruited from a single center. FACT-G, CTCL-S (collectively "FACT-CTCL"), Skindex29, and Visual Analogue Scale-Pruritis (VAS itch) were administered. A subset repeated FACT-CTCL and VAS itch after ≈2 weeks. Patient demographics and clinical characteristics were obtained via review of the electronic medical record.Psychometric properties were assessed. Internal consistency was estimated using Cronbach's alpha (α). Convergent and discriminant validity were assessed by comparing CTCL-S to disease stage, age, VAS itch, FACT-G, and SkinDex29. Exploratory factor analysis (EFA) was used to preliminarily assess CTCL-S dimensionality. Test-retest repeatability was summarized using intraclass correlation coefficient (ICC), within-subject standard deviation (wSD), and within-subject coefficient of variation. Seventy-two patients completed the initial survey, and 35 repeated the FACT-CTCL and VAS itch after ≈2 weeks. Two-thirds were male, most were white (78%). The majority (85%) had MF, 15% SS, and 75% early (stage IA-IIA) and 25% advanced (≥ stage IIB) disease. Preliminary EFA found a single predominant factor, supporting a hypothesis of unidimensionality of the CTCL-S. Internal consistency of the CTCL-S was high (α: 0.95 [95% CI: 0.93-0.96]). There was no significant change in CTCL-S average test-retest scores (ICC of 0.93 (p = 0.63)). CTCL-S was significantly lower in advanced vs early stage disease (median[IQR]: 34[26, 48] vs. 59[44, 68], p < 0.001) and strongly correlated with VAS itch (Spearman's r (rs): -0.70, 95% CI: -0.81, -0.55), FACT-G (rs: 0.77, 95% CI: 0.65, 0.85), and Skindex29 (rs: -0.90, 95% CI: -0.94, -0.84), supporting convergent validity. CTCL-S scores had little correlation with age (rs: 0.19, 95% CI: -0.05, 0.41, p = 0.12), supporting discriminant validity. The FACT-CTCL is a disease specific instrument for assessing HRQoL with high reproducibility and good performance in a cohort of patients with MF/SS.

Repeatability and agreement of total corneal astigmatism measured in keratoconic eyes using four current devices.

To evaluate repeatability and agreement in measurements of total corneal astigmatism (TCA) in keratoconic eyes, using four optical coherence tomography (OCT)-based devices: Anterion, Casia SS-1000, IOLMaster 700, and MS-39. Three consecutive measurements were taken with each device in 136 eyes. TCA values were converted into components J0 and J45. The Anterion and the IOLMaster 700 also provided axial length (AL) measurements. The repeatability was calculated using pooled within-subject standard deviation (Sw). The agreement among the four devices was assessed by pairwise comparisons and Bland-Altman plots. For all devices, the repeatability of TCA measurements showed Sw ≤0.23 D for TCA magnitude, ≤0.14 D for J0, and ≤0.12 D for J45. There were statistically significant differences in TCA magnitude for each pair, except for IOLMaster 700 with MS-39, and Anterion with MS-39. The repeatability (Sw) of axis measurements had a statistically significant negative correlation with the TCA magnitude (p < 0.001 for all devices). Both Anterion and IOLMaster 700 had high repeatability in AL measurements (Sw: 0.007 mm for Anterion and 0.009 mm for IOLMaster 700). The difference in AL between the two was 0.015 ± 0.033 mm (p < 0.001). All four devices showed good repeatability in TCA measurements in keratoconic eyes, the agreement for TCA measurements between the tested devices was generally low. Anterion and IOLMaster 700 showed good repeatability and agreement in AL measurements.

Three-dimensional simultaneous T1 and T2* relaxation times and quantitative susceptibility mapping at 3 T: A multicenter validation study

We aimed to determine the intra-site repeatability and cross-site reproducibility of T1 and T2* relaxation times and quantitative susceptibility (χ) values obtained through quantitative parameter mapping (QPM) at 3 T. This prospective study included three 3-T scanners with the same hardware and software platform at three sites. The brains of twelve healthy volunteers were scanned three times using QPM at three sites. Intra-site repeatability and cross-site reproducibility were evaluated based on voxel-wise and region-of-interest analyses. The within-subject coefficient of variation (wCV), within-subject standard deviation (wSD), linear regression, Bland–Altman plot, and intraclass correlation coefficient (ICC) were used for evaluation. The intra-site repeatability wCV was 11.9 ± 6.86% for T1 and 3.15 ± 0.03% for T2*, and wSD of χ at 3.35 ± 0.10 parts per billion (ppb). Intra-site ICC(1,k) values for T1, T2*, and χ were 0.878–0.904, 0.972–0.976, and 0.966–0.972, respectively, indicating high consistency within the same scanner. Linear regression analysis revealed a strong agreement between measurements from each site and the site-average measurement, with R-squared values ranging from 0.79 to 0.83 for T1, 0.94–0.95 for T2*, and 0.95–0.96 for χ. The cross-site wCV was 13.4 ± 5.47% for T1 and 3.69 ± 2.25% for T2*, and cross-site wSD of χ at 4.08 ± 3.22 ppb. The cross-site ICC(2,1) was 0.707, 0.913, and 0.902 for T1, T2*, and χ, respectively. QPM provides T1, T2*, and χ values with an intra-site repeatability of <12% and cross-site reproducibility of <14%. These findings may contribute to the development of multisite studies.

Repeatability of Automatic Measurements by an Anterior Segment Swept-Source OCT Biometer in Patients With Keratoconus.

To evaluate the repeatability of automatic measurements of a new anterior segment optical coherence tomographer (ANTERION; Heidelberg Engineering) and their agreement with an anterior segment optical coherence tomography device combined with Placido disc corneal topography (MS-39; CSO) in patients affected by keratoconus. Fifty-four consecutive patients were included. Three measurements were performed with the ANTERION and one with the MS-39. Repeatability was assessed by means of within-subject standard deviation, coefficient of variation (CoV), and intraclass correlation coefficient (ICC). Agreement was investigated with the 95% limits of agreement. The paired t-test and Wilcoxon matched-pairs test were performed to compare the measurements of the different devices. Repeatability of ANTERION measurements was high, with an ICC greater than 0.98 for all parameters. Many parameters revealed a CoV of less than 1% and a CoV within 5% was obtained for astigmatism measurements. The ANTERION measured a significantly higher corneal power and the MS-39 more negative posterior keratometric values. These differences were mirrored by a moderate agreement for mean simulated keratometry and poor agreement for total corneal power and posterior keratometry. The ANTERION revealed high repeatability of automatic measurements and good agreement with the MS-39 for many parameters in patients affected by keratoconus, but for most parameters the two instruments cannot be considered interchangeable. [J Refract Surg. 2024;40(7):e445-e452.].

Refractive power profiles of commercially available soft multifocal contact lenses for myopia control.

Lens power profiles can provide valuable insights on the imposed optical defocus and visual experience of contact lens wearers, especially in the context of myopia control. This study measured the refractive power profiles of multifocal soft contact lenses (MFCLs) currently used or that have the potential for use in myopia control using high spatial resolution aberrometry. The instrument's repeatability for determining MFCLs power profiles was also assessed. The power profiles of 10 MFCLs of various designs (centre-distance, centre-near and extended depth of focus) were measured using the Lambda-X NIMOEVO, a phase shifting Schlieren-based device. Power profiles were graphically expressed as measured power at each chord position and the maximum add power was calculated. The repeatability of the NIMOEVO was expressed as the within-subject standard deviation at each chord position for a subset of five MFCLs. The measured distance powers differed from nominal powers for more than half of the MFCLs with a definable distance zone. There were variations in the chord position of the distance and near correction zones, rate of power transitions and calculated maximum add between the MFCLs which did not depend on lens design. For half of the MFCLs, the power profile shape was inconsistent between different nominal back vertex powers of the same design. The repeatability of the NIMOEVO was dependent on the lens design, with designs featuring faster rates of power change exhibiting worse repeatability. Significant differences in MFCL power profiles were found which were not adequately represented in labelling. This is likely due to the small number of parameters used to define lens power characteristics. Eye health care practitioners should be aware of potential differences in power profiles between different MFCLs, which will impact the retinal defocus introduced during lens wear and the wearer's visual experience.

Pharmacokinetics and Bioequivalence of Two Formulations of Azithromycin Tablets: A Randomized, Single-Dose, Three-Period, Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed Conditions.

Azithromycin is the first azalide antibiotic that is related to the macrolide family of antibiotics. Bioequivalence studies in China are initiated by the National Medical Products Administration (NMPA), which supports a generic consistency evaluation program for ensuring that generic products manufactured in China meet the required standards and provide equivalent therapeutic effects to their reference products. This study aimed to assess the bioequivalence of two azithromycin tablets under both fasting and fed conditions in healthy Chinese volunteers. This was a single-center, open-label, single-dose, randomized, three-way crossover trial with two independent groups (fasting group and fed group). A total of 72 healthy Chinese subjects (36 subjects in the fasting state and 36 subjects in the fed state) were enrolled and randomized to treatment. Blood samples were collected from 0 to 120 h after a single oral dose of a 250-mg generic azithromycin tablet (test, T) or branded azithromycin tablet (reference, R). The plasma concentrations of azithromycin were determined by high-performance liquid chromatography-tandem mass spectrometry (HPLC‒MS/MS). A non-compartmental analysis method was used to estimate the pharmacokinetic parameters. Adverse events were documented. In a fasting state, the bioequivalence of maximum plasma concentration (Cmax) was evaluated using the reference-scaled average bioequivalence (RSABE) approach (within-subject standard deviation, SWR >0.294), and the bioequivalence of area under the concentration-time curve from time 0 to the time of the last measurable plasma concentration (AUC0-t) and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) were evaluated by the average bioequivalence (ABE) method (SWR < 0.294). The geometric mean ratio (GMR) of T/R for Cmax was 106.49%, while the 95% upper confidence bound was < 0. The GMRs of AUC0-t and AUC0-∞ were 103.34% and 101.28%, and the 90% confidence intervals (CIs) of the test/reference were 95.90-111.35%/94.85-108.15%, respectively. In the fed state, the RSABE approach was applied to estimate the bioequivalence of Cmax (SWR >0.294), and the ABE approach was applied to estimate the bioequivalence of AUC0-t and AUC0-∞ (SWR < 0.294). The GMR for Cmax was 99.80%, while the 95% upper confidence bound value was < 0. The GMRs of AUC0-t and AUC0-∞ were 97.07% and 98.15%, and the 90% CIs of the T/R were 90.02-104.68% and 90.66-106.25%, respectively. All adverse events were mild and transient. The trial indicated that the test and the reference azithromycin tablets were bioequivalent and well tolerated in healthy Chinese volunteers under both fasting and fed conditions. Clinicaltrials, ChiCTR2300071630 (retrospectively registered in 19/05/2023).

Suitability of multifunction devices Myah and Myopia Master for monitoring myopia progression in children and adults.

To assess the feasibility of using multifunction instruments to measure axial length for monitoring myopia progression in children and adults. Axial length was measured in 60 children (aged 6-18 years) and 60 adults (aged 19-50 years) with multifunction instruments (Myah and Myopia Master) and stand-alone biometers (Lenstar LS900 and IOLMaster 700). Repeatability (measurements by the same examiner) and reproducibility (measurements by different examiners) were computed as the within-subject standard deviation (Sw) and 95% limits of agreement (LoA). Inter-instrument agreement was computed as intraclass correlation coefficients. The threshold for detecting myopic progression was taken as 0.1 mm. Measures were repeated only in children following the administration of 1% tropicamide to determine the impact of cycloplegia on axial length. Overall, the IOLMaster 700 had the best repeatability in children (0.014 mm) and adults (0.009 mm). Repeatability Sw values for all devices ranged from 0.005 to 0.021 mm (children) and 0.003 to 0.016 mm (adults). In children, reproducibility fell within 0.1 mm 95% of the time for the Myah, Myopia Master and IOLMaster 700. Agreement among all devices was classified as excellent (ICC 0.999; 95% CI 0.998-0.999), but the 95% LoA among the Myah, Myopia Master and Lenstar LS900 was ≥0.1 mm. Cycloplegia had no statistically significant effect on axial length (all p > 0.13). The Myah and Myopia Master multifunction instruments demonstrated good repeatability and reproducibility, and their accuracy was comparable to stand-alone biometers. Axial length measurements using different instruments can be considered interchangeable but should be compared with some caution. Accurate axial length measurements can be obtained without cycloplegia. The multifunction instruments Myah and Myopia Master are as well suited for monitoring myopia progression in children asthe stand-alone biometers IOLMaster 700 and Lenstar LS900.

A single-dose, randomized, open-label, four-period, crossover equivalence trial comparing the clinical similarity of the proposed biosimilar rupatadine fumarate to reference Wystamm® in healthy Chinese subjects.

The aim of this study was to evaluate the bioequivalence of two formulations of rupatadine (10-mg tablets) under fasting and fed conditions in healthy Chinese subjects. A total of 72 subjects were randomly assigned to the fasting cohort (n = 36) and fed cohort (n = 36). Each cohort includes four single-dose observation periods and 7-day washout intervals. Blood samples were collected at several timepoints for up to 72h post-dose. The plasma concentration of rupatadine and the major active metabolites (desloratadine and 3-hydroxydesloratadine) were analyzed by a validated HPLC-MS/MS method. The non-compartmental analysis method was employed to determine the pharmacokinetic parameters. Based on the within-subject standard deviation of the reference formulation, a reference-scaled average bioequivalence or average bioequivalence method was used to evaluate the bioequivalence of the two formulations. For the fasting status, the reference-scaled average bioequivalence method was used to evaluate the bioequivalence of the maximum observed rupatadine concentration (Cmax; subject standard deviation > 0.294), while the average bioequivalence method was used to evaluate the bioequivalence of the area under the rupatadine concentration-time curve from time 0 to the last detectable concentration (AUC0-t) and from time 0 to infinity (AUC0-∞). The geometric mean ratio (GMR) of the test/reference for Cmax was 95.91%, and the upper bound of the 95% confidence interval was 95.91%. For AUC0-t and AUC0-∞ comparisons, the GMR and 90% confidence interval (CI) were 98.76% (93.88%-103.90%) and 98.71% (93.93%-103.75%), respectively. For the fed status, the subject standard deviation values of Cmax, AUC0-t, and AUC0-∞ were all <0.294; therefore, the average bioequivalence method was used. The GMR and 90% CI for Cmax, AUC0-t, and AUC0-∞ were 101.19% (91.64%-111.74%), 98.80% (94.47%-103.33%), and 98.63% (94.42%-103.03%), respectively. The two-sided 90% CI of the GMR for primary pharmacokinetic endpoints of desloratadine and 3-hydroxydesloratadine was also within 80%-125% for each cohort. These results met the bioequivalence criteria for highly variable drugs. All adverse events (AEs) were mild and transient. The test drug rupatadine fumarate showed a similar safety profile to the reference drug Wystamm® (J. Uriach y Compañía, S.A., Spain), and its pharmacokinetic bioequivalence was confirmed in healthy Chinese subjects based on fasting and postprandial status. http://www.chinadrugtrials.org.cn/index.html, identifier CTR20213217.

Effect of Long-Acting Diquafosol Sodium on Astigmatism Measurement Repeatability in Preoperative Cataract Cases with Dry Eyes: A Multicenter Prospective Study.

Dry eye can compromise corneal astigmatism measurement repeatability during preoperative cataract surgery examination. No previous studies have analyzed the effectiveness of long-acting 3% diquafosol sodium (LA-DQS) on astigmatism measurement repeatability. This research assessed the effect of LA-DQS on astigmatism measurement repeatability in preoperative patients with cataract and short tear break-up time (TBUT) type dry eyes in both eyes of the same patient. Correlations between repeatability and TBUT, corneal high-order aberrations (HOAs), and corneal astigmatism magnitude were also analyzed. In total, 122 eyes (61 patients) with short TBUT-type dry eye were enrolled. Preoperatively, only one eye of all patients was treated with LA-DQS for 4 weeks. TBUT and corneal HOAs were checked using CASIA 2 before and 4 weeks post-treatment. The cylindrical power and meridian of astigmatism were measured at 3- and 4-week post-treatment using IOLMaster 700. Power vectors J0 and J45 were used for astigmatism calculations. Repeatability of astigmatism measurements was assessed as the within-subject standard deviation (Sw). The relative effects of TBUT and HOAs on J0 Sw and J45 Sw were also analyzed. Comparative changes in these variables were evaluated between treated and non-treated eyes, with additional analysis of their correlations. Treated eyes exhibited significant improvements in TBUT, HOAs, and post-treatment measurements of J0 Sw and J45 Sw at 3 and 4 weeks. In non-treated eyes, J0 Sw and J45 Sw showed significant correlation with TBUT and corneal HOAs. HOAs showed stronger relative associations with J0 Sw and J45 Sw than TBUT. In non-treated eyes, no significant correlation was found between cylindrical power and astigmatism measurement repeatability. In short TBUT-type dry eye, preoperative treatment with LA-DQS significantly improved astigmatism measurement repeatability. This may improve the precision of intraocular lens (IOL) power calculations regardless of the magnitude of corneal astigmatism, especially when toric IOLs are used.

Repeatability of Epithelium Thickness Measured by an AS-OCT in Different Grades of Keratoconus and Compared to AS-OCT/Placido Topography

To compare agreement of corneal epithelium thickness (ET) between AS-OCT system (RTVue, Optovue, Fremont, USA) and AS-OCT/Placido topographer (MS-39, CSO, Florence, Italy) in different stages keratoconus (KC) eyes, and to assess the repeatability of RTVue AS-OCT. Prospective reliability analysis. KC eyes were classified into forme fruste KC (FFKC), mild, moderate and severe KC. Agreement was evaluated with Bland-Altman plots and 95% limits of agreement (LoA). The repeatability of RTVue was assessed via within-subject standard deviation (Sw), test-retest variability (TRT), coefficient of variation (CoV), and intraclass correlation coefficient (ICC). Totally, 119 KC eyes were enrolled, with 21 FFKC, 26 mild, 39 moderate, and 34 severe. The 95% LoA ranged between -5.9 and 4.8 μm for center epithelium thickness (CET), between -5.7 and 8.2 μm for thinnest epithelium thickness (TET). At 1mm measuring points, the 95% LoA of superior, inferior, nasal and temporal were -4.2 to 4.7 μm, -5.2 to 6.0 μm, -7.9 to 10.2 μm, -11.2 to 6.0 μm. At 3mm measuring points, the corresponding values were -2.8 to 9.3 μm, -2.0 to 13.0 μm, -4.6 to 9.6 μm, -6.3 to 9.7 μm, indicating the two instruments weren't interchangeable without adjustment. Despite the repeatability of RTVue in KC patients were acceptable, repeatability decreased gradually with the peripheralization of the measurement points. The two OCT-based devices, RTVue and MS-39, don't provide interchangeable measurements of ET in KC patients. Repeatability decreases in severer KC, emphasizing the importance of grading before clinical examination to avoid diagnostic errors.

Night-to-night variability of objective sleep outcomes in youth Middle Eastern football players

ObjectiveTo describe components of night-to-night variation in objective measures of sleep. MethodsWe conducted a secondary data analysis of consecutive and chronologically ordered actigraphy-based measurements for time in bed (min), time asleep (min), and wake-after-sleep onset (min). This investigation examined 575 individual night-based measures available for a sub-sample of fifty-two, male youth Middle Eastern football players tracked over a 14-day surveillance period (chronological age range: 12.1 to 16 years). Distinct multivariable-adjusted generalized additive models included each objective sleep outcome measure as dependent variable and disaggregated components of variation for night measurement-by-sleep period interaction, week part (weekday or weekend), and study participant random effects from within-subject night-to-night sleep variation. ResultsThe within-subject standard deviation (SD) of ±98 min (95% confidence interval [CI], 92 to 104 min) for time in bed, ±87 min (95%CI, 82 to 93 min) for time asleep, and ±23 min (95%CI, 22 to 25 min) for wake-after-sleep-onset overwhelmed other sources of variability and accounted for ∼44% to 53% of the overall night-to-night variation. The night measurement-by-fragmented sleep period interaction SD was ±83 min (95%CI, 44 to 156 min) for time in bed, ±67 min (95%CI, 34 to 131 min) for time asleep, and ±15 min (95%CI, 7 to 32 min) for wake-after-sleep-onset that accounted for ∼22% to 32% of each sleep outcome measure overall variability. ConclusionsSubstantial random night-to-night within-subject variability poses additional challenges for strategies aiming to mitigate problems of insufficient and inconsistent sleep that are detrimental to school learning and youth athlete development processes.

Repeatability of pyramidal aberrometer measurements in keratoconus and normal eyes.

To evaluate the intrasubject repeatability of pyramidal aberrometer measurements in a sample of keratoconus and normal eyes. American University of Beirut Medical Center, Beirut, Lebanon. Prospective comparative repeatability analysis. Study population: Keratoconus and normal eyes from adult patients. Observation procedures: Each eye was evaluated with 3 consecutive acquisitions using a pyramidal aberrometer. Main outcome measures: The repeatability of different ocular higher-order aberrations and lower-order aberrations (HOAs and LOAs, respectively), and Zernike coefficients down to the fifth order, was evaluated. Repeatability was assessed by within-subject SDs (Sw), repeatability limits ( r ), and intraclass correlation coefficients (ICCs), among other parameters. 72 keratoconus patients (72 eyes) and 76 normal patients (76 eyes) were included. In normal and keratoconus eyes, the ICC of total LOAs and HOAs, as well as each of the Zernike coefficients, was >0.9. The Sw for keratoconus eyes with mean maximal keratometry (Kmax) <50 diopters (D) was 0.1345 for total LOAs, 0.0619 for total HOAs, 0.0292 for horizontal coma, 0.0561 for vertical coma, and 0.0221 for spherical aberration as compared with 0.2696, 0.1486, 0.0972, 0.1497, and 0.0757 for keratoconus eyes with Kmax ≥50 D. Similar trend of better repeatability for grade 1 keratoconus and HOAs <2 D as compared with grades 2 and 3 keratoconus and eyes with HOAs >2 D were also noted. Ocular aberrometer measurements generated by high definition pyramidal aberrometers have high repeatability in both normal and mild keratoconus eyes and moderate repeatability, yet still clinically acceptable, in advanced keratoconus. This is of particular importance in ocular wavefront-guided treatments.

Clinical Evaluation of a New Spectral-Domain Optical Coherence Tomography-Based Biometer.

The VEMoS-AXL system is a new optical biometer based on spectral domain optical coherence tomography (SD-OCT) that has been tested in terms of intrasession repeatability and compared with a swept-source optical coherence tomography biometer (SS-OCT), which is recognized as the gold standard for the performance of an agreement analysis. A biometric analysis was performed three consecutive times in 120 healthy eyes of 120 patients aged between 18 and 40 years with the SD-OCT system, and afterwards, a single measurement was obtained with the SS-OCT system. Within-subject standard deviations were 0.004 mm, 4.394 µm, and 0.017 mm for axial length (AL), central corneal thickness (CCT), and anterior chamber depth (ACD) measures obtained with the SD-OCT biometer, respectively. The agreement between devices was good for AL (limits of agreement, LoA: -0.04 to 0.03 mm) and CCT (LoA: -4.36 to 14.38 µm), whereas differences between devices were clinically relevant for ACD (LoA: 0.03 to 0.21 mm). In conclusion, the VEMoS-AXL system provides consistent measures of anatomical parameters, being most of them interchangeable with those provided by the SS-OCT-based gold standard.

Evaluation of a new dynamic real-time visualization 25 kHz swept-source optical coherence tomography based biometer

BackgroundTo evaluate the intraobserver repeatability and interobserver reproducibility of a newly developed dynamic real-time visualization 25 kHz swept-source optical coherence tomography (SS-OCT) based biometer (ZW-30, TowardPi Medical Technology Ltd, China) and compare its agreement with another SS-OCT based biometer (IOLMaster 700, Carl Zeiss Meditec AG, Jena, Germany).MethodsEighty-two healthy right eyes were enrolled in this prospective observational study. Measurements were repeated for three times using the ZW-30 and IOLMaster 700 in a random order. Obtained parameters included axial length (AL), central corneal thickness (CCT), aqueous depth (AQD), anterior chamber depth (ACD), lens thickness (LT), mean keratometry (Km), astigmatism magnitude (AST), vector J0, vector J45, and corneal diameter (CD). The within-subject standard deviation (Sw), test–retest (TRT) variability, coefficient of variation (CoV), and intraclass correlation coefficient (ICC) were adopted to assess the intraobserver repeatability and interobserver reproducibility. The double-angle plot was also used to display the distribution of AST. To estimate agreement, Bland–Altman plots were used.ResultsFor the intraobserver repeatability and interobserver reproducibility, the Sw, TRT and CoV for all parameters were low. Meanwhile, the ICC values were all close to 1.000, except for the J45 (ICC = 0.887 for the intraobserver repeatability). The double-angle plot showed that the distribution of AST measured by these two devices was similar. For agreement, the Bland–Altman plots showed narrow 95% limits of agreements (LoAs) for AL, CCT, AQD, ACD, LT, Km AST, J0, J45, and CD (− 0.02 mm to 0.02 mm, − 7.49 μm to 8.08 μm, − 0.07 mm to 0.04 mm, − 0.07 mm to 0.04 mm, − 0.07 mm to 0.08 mm, − 0.16 D to 0.30 D, − 0.30 D to 0.29 D, − 0.16 D to 0.16 D, − 0.23 D to 0.13 D, and − 0.39 mm to 0.10 mm, respectively).ConclusionsThe newly dynamic real-time visualization biometer exhibited excellent intraobserver repeatability and interobserver reproducibility. The two devices both based on the SS-OCT principle had similar ocular parameters measurement values and can be interchanged in clinical practice.

Assessing progression limits in different grades of keratoconus from a novel perspective: precision of measurements of the corneal epithelium

BackgroundTo assess repeatability and reproducibility of corneal epithelium thickness (ET) measured by a spectral-domain optical coherence tomographer (SD-OCT)/Placido topographer (MS-39, CSO, Florence, Italy) in keratoconus (KC) population at different stages, as well as to determine the progression limits for evaluating KC progression.MethodsA total of 149 eyes were enrolled in this study, with 29 eyes in the forme fruste keratoconus (FFKC) group, 34 eyes in the mild KC group, 40 eyes in the moderate KC group, and 46 eyes in the severe KC group. Employing the within-subject standard deviation (Sw), test-retest variability (TRT), coefficient of variation (CoV), and intraclass correlation coefficient (ICC) to evaluate intraoperator repeatability and interoperator reproducibility.ResultsThe repeatability and reproducibility of MS-39 in patients with KC were acceptable, according to ICC values ranging from 0.732 to 0.954. However, patients with more severe KC and progressive peripheralization of the measurement points had higher TRTs but a thinning trend. The current study tended to set the cut-off values of mild KC, moderate KC, and severe KC to 4.9 µm, 5.2 µm, and 7.4 µm for thinnest epithelium thickness (TET). When differences between follow-ups are higher than those values, progression of the disease is possible. As for center epithelium thickness (CET), cut-off values for mild KC, moderate KC, and severe KC should be 2.8 µm, 4.4 µm, and 5.3 µm. This might be useful in the follow-up and diagnosis of keratoconus.ConclusionsThis study demonstrated that the precision of MS-39 was reduced in measuring more severe KC patients and more peripheral corneal points. In determining disease progression, values should be differentiated between disease-related real changes and measurement inaccuracies. Due to the large difference in ET measured by MS-39 between various stages of disease progression, it is necessary to accurately grade KC patients to avoid errors in KC clinical decision-making.

Repeatability of Corneal Aberrations and Ocular Biometry Measurements Using the Pentacam® AXL: A Cross-sectional Study

Introduction: Accurate assessment of ocular biometry and corneal aberrations for diagnosis and therapy is crucial in many clinical settings. Devices to improve the measurements of these parameters are constantly being developed. Aim: To evaluate the repeatability of ocular biometry and corneal aberrations obtained by the Pentacam® AXL in normal eyes. Materials and Methods: This cross-sectional study was conducted in the Optometry Department of King Saud Universiy, Riyadh, Saudi Arabia from September 2021 to February 2022. The study included a total of 120 eyes from 60 normally sighted adult participants whose of ocular biometry and corneal aberrations were measured three times in a single session using the Pentacam® AXL. Biometric parameters include Axial Length (AL), mean K-reading (Km), Anterior Chamber Depth (ACD), Central Corneal Thickness (CCT), and Horizontal White-toWhite Distance (HWTW). The aberrometry parameters include the most significant corneal higher-order aberrations (coma, trefoil, spherical aberration), and the Root Mean Square (RMS) of the higher-order aberrations. Repeatability was assessed using within-subject Standard Deviation (SDw), the repeatability limit (r), and the Intraclass Correlation Coefficient (ICC). Results: The current study included 120 eyes of 60 subjects with a mean age of 21±2.08 years (range: 18 to 28 years). The repeatability was good for all recorded biometric measurements, with the most repeatable being AL (r=0.028, SD=0.01). All values of ICC for biometric measurements revealed excellent repeatability, being over 0.994. In addition, coma and spherical aberrations had excellent repeatability with ICC ≥0.935, and RMS, trefoil, secondary astigmatism, and quadrafoil aberrations had good repeatability with ICC 0.938, 0.823, 0.898, and 0.827, respectively. Conclusion: The Pentacam® AXL demonstrated good repeatability for ocular biometry and corneal aberrations in healthy eyes.

Repeatability and reproducibility comparisons of liver IVIM imaging with free-breathing or respiratory-triggered sequences.

For liver intravoxel incoherent motion (IVIM) data acquisition, respiratory-triggering (RT) MRI is commonly used, and there are strong motivations to shorten the scan duration. For the same scan duration, more b values or higher numbers of excitations can be allowed for free-breathing (FB) imaging than for RT. We studied whether FB can be used to replace RT when careful IVIM image acquisition and image processing are conducted. MRI data of 22 healthy participants were acquired using a 3.0 T scanner. Diffusion imaging was based on a single-shot spin-echo-type echo-planar sequence and 16 b values of 0, 2, 4, 7, 10, 15, 20, 30, 46, 60, 72, 100, 150, 200, 400, and 600 s/mm2 . Each subject attended two scan sessions with an interval of 10-20 days. For each scan session, a subject was scanned twice, first with RT and then with FB. The mean image acquisition time was 5.4 min for FB and 10.8 min for RT. IVIM parameters were calculated with bi-exponential model segmented fitting with a threshold b value of 60 s/mm2 , and fitting started from b= 2 s/mm2 . There was no statistically significant difference between IVIM parameters measured with FB imaging or RT imaging. Perfusion fraction ICC (intraclass correlation coefficient) for FB imaging and RT imaging in the same scan session was 0.824. For perfusion fraction, wSD (within-subject standard deviation), BA (Bland-Altman) difference, BA 95% limit, and ICC were 0.022, 0.0001, -0.0635~0.0637, and 0.687 for FB and 0.031, 0.0122, -0.0723~0.0967, and 0.611 for RT. For Dslow (×10-3 s/mm2 ), wSD, BA difference, BA 95% limit, and ICC were 0.057, 0.0268, -0.1258~0.1793, and 0.471 for FB and 0.073, -0.0078, -0.2170-0.2014, and <0.4 for RT. The Dfast coefficient of variation was 0.20 for FB imaging and 0.28 for RT imaging. All reproducibility indicators slightly favored FB imaging.

The Repeatability of Axial Length Measurements Using a Scheimpflug-based System.

To assess the repeatability of Pentacam AXL as a Scheimpflug-based system or measuring axial length according to the age, sex, lens type, axial length value, and type of cataract. The present study was conducted using multistage cluster sampling in Tehran, Iran. Ocular biometry was performed, using the Pentacam AXL, by an experienced optometrist on all the participants. The axial length (AL) measurements were taken thrice, with a gap of 10 minutes. To evaluate the repeatability, the intraclass correlation coefficient (ICC) and the repeatability coefficient (RC) were calculated. To determine the significant difference in the repeatability index among study variables, the tolerance index (TI) was calculated. In this report, 897 eyes of 677 individuals aged between 20 and 91 years (mean SD: 64.90 13.62 years) were reported. The ICC of the axial length measurements was 0.981 for all cases. Based on the within-subject standard deviation, the RC was 0.401. The ICC was 0.976 and 0.985 in men and women, respectively. The TI showed better RC of measurements among females. The ICC decreased from 0.999 in participants under 40 years to 0.973 in individuals over 60 years of age. The TI showed a decrease in RC with advancing age. The RC was worse in eyes with nuclear cataracts; the RC was also worse in the first quartile of the signal-to-noise ratio (SNR) compared to the other SNR quartiles. The Scheimpflug-based systemPentacam AXL had high repeatability in measuring axial length. Some variables such as male gender, older age, and nuclear cataract were associated with reduced repeatability of the measurements. A higher SNR was associated with better repeatability of the axial length measurements.

Precision and agreement of axial length in paediatric population measured with MYAH and AL-Scan biometers

ABSTRACT Clinical relevance Measuring axial length is key in the field of myopia development and control. Hence, the precision and agreement of commercially available biometers is of vital interest to understand their variability and interchangeability in the paediatric population. Background Different biometers are available to measure axial length and monitor myopia progression in clinical practice. The purpose of this study was to assess the precision (repeatability and reproducibility) and agreement of the MYAH and AL-Scan biometers in a paediatric population. Methods Three consecutive measurements were performed using MYAH and AL-Scan biometers in each subject by the same operator to test for repeatability. To test for reproducibility, two measurements were performed for each subject by two different observers with a 5-min interval between measurements. To test the agreement, each subject was measured once with each instrument. Results A total of 187 subjects, with a mean age of 8.5 ± 0.3 years and mean spherical equivalent refractive error of +0.22 ± 0.77 D participated in the study. For the repeatability study, the within-subject standard deviation was 0.01 mm, and the repeatability limit was 0.04 mm for both instruments, with no statistically significant differences among repeated measures (p = 0.162 for MYAH and p = 0.774 for AL-Scan). For the reproducibility study, the within-subject standard deviation was 0.01 mm and the repeatability limit was 0.04 mm. There were statistically significant differences for the repeated measures for the AL-Scan (p = 0.002) but not for the MYAH (p = 0.643). Regarding the agreement between both instruments, the 95% limit of agreement ranged from −0.04 to 0.05 mm, and the differences were statistically significant (p = 0.021). Conclusions The repeatability, reproducibility, and agreement of the MYAH and AL-Scan biometers seem optimal for following children with myopia.

Abstract 18759: Reliability and Accuracy of Non-Invasive versus Invasive Blood Pressure Monitoring During Atrial Fibrillation Ablation

Introduction Patients with atrial fibrillation (AF) have multiple confounders that could affect the reliability of non-invasive blood pressure (NIBP). We sought to investigate if AF and paced rhythms (PR) modify the reliability of NIBP and accuracy against an invasive blood pressure (IBP) reference, as compared to sinus rhythm (SR), and impact NIBP validity for procedural monitoring. Hypothesis Changes in heart rhythm between AF, SR and PR, within a patient would not alter the reliability and accuracy of NIBP. Methods We conducted an observational study in patients undergoing an AF ablation procedure under general anesthesia with paired IBP, NIBP, and heart rhythm measurements available. Results We evaluated 91 patients ( Table 1 ) with 1,179 usable NIBP vs. IBP pairs; 547 (46.4%) during SR, 376 during AF (31.9%), and 256 (21.7%) during PR. In the entire sample, the average difference (standard error) between systolic NIBP and IBP was 2.9 (1.8) mmHg (P=0.10 against H0=0) with a within-subject standard deviation (SD) for the difference of 11.6 mmHg and intraclass correlation coefficient of 0.76 ( Fig. 1 ). Systolic NIBP was higher on average vs. IBP when in SR (6.2 [1.1] mmHg; P&lt;0.001), but not when in AF (1.5 [2.6] mmHg; P=0.55) or in PR (-2.0 [3.3] mmHg; P=0.54). However, the within-patient SD of the difference was high in SR, AF, and PR (SD 10.5, 12.9, and 11.9 mmHg, respectively). Results were similar for diastolic and mean NIBP vs. IBP. Conclusion AF or PR, as compared to SR, did not materially change the reliability and accuracy of NIBP vs. IBP. However, the high within-patient variation in systolic NIBP versus IBP raises concerns on the validity of NIBP for systolic blood pressure monitoring.