Cost-effectiveness of selective bone densitometry using the osteoporosis self-assessment tool for Asians in multi-ethnic Asian population.

Early detection and treatment of osteoporosis can help to prevent debilitating fractures in the elderly. The osteoporosis self-assessment tool for Asians can be used as a screening tool to stratify patients for bone densitometry. It is most cost-effective for post-menopausal women aged 70 and males aged 75. PURPOSE: To determine the cost-effectiveness of selective bone densitometry (SBD) using the Osteoporosis Self-Assessment Tool for Asians (OSTA) as a risk-stratifying tool for the three predominant races (Chinese, Malay and Indian) in Singapore. METHODS: Decision analytical models were developed using a Markov model. Three scenarios were compared: no bone densitometry, SBD using the OSTA as a pre-screening tool and universal bone densitometry. Those diagnosed with osteoporosis were treated with five years of alendronate therapy. Data sources were from Singapore epidemiological studies, healthcare cost figures and published literature. Measurements include life years, quality-adjusted life years (QALYs), costs and incremental cost-effectiveness ratios (ICER). RESULTS: Compared to no bone densitometry, SBD using the OSTA would cost between $40,679 and $73,909 per QALY gained for men aged 75-80 and $22,386 to $58,185 per QALY gained for post-menopausal women aged 70-80. Universal bone densitometry would cost $157,955 to $177,127 per QALY gained for men aged 75-80 and $40,179 to $66,112 per QALY gained for post-menopausal women aged 70 to 80 compared to SBD. CONCLUSION: In general, osteoporosis screening was the most cost-effective for Malays and the least cost-effective for Indians. However, a general guideline should still be applied to the Singaporean population, as further explained later. Overall, the most cost-effective strategy for males would be using OSTA as a risk-stratifying tool at age 75. For post-menopausal women, SBD should be used for women aged 70, while universal bone densitometry should be used for women aged 75-80.

Optical bone densitometry robust to variation of soft tissue using machine learning techniques: validation by Monte Carlo simulation.

SIGNIFICANCE: To achieve early detection of osteoporosis, a simple bone densitometry method using optics was proposed. However, individual differences in soft tissue structure and optical properties can cause errors in quantitative bone densitometry. Therefore, developing optical bone densitometry that is robust to soft tissue variations is important for the early detection of osteoporosis. AIM: The purpose of this study was to develop an optical bone densitometer that is insensitive to soft tissue, using Monte Carlo simulation and machine learning techniques, and to verify its feasibility. APPROACH: We propose a method to measure spatially resolved diffuse light from three directions of the biological tissue model and used machine learning techniques to predict bone density from these data. The three directions are backward, forward, and lateral to the direction of ballistic light irradiation. The method was validated using Monte Carlo simulations using synthetic biological tissue models with 1211 different random structural and optical properties. RESULTS: The results were computed after a 10-fold cross-validation. From the simulated optical data, the machine learning model predicted bone density with a coefficient of determination of 0.760. CONCLUSIONS: The optical bone densitometry method proposed in this study was found to be robust against individual differences in soft tissue.

Skeletal muscle radiodensity and visceral adipose tissue index are associated with survival in renal cell cancer - A multicenter population-based cohort study.

INTRODUCTION: Body composition has been associated with disease outcome in several cancer types. Results for localized and metastatic renal cell cancer (RCC) are limited and inconsistent. Our aim was to examine the association between body composition and survival in RCC. METHODS: We conducted a population-based historical cohort study including patients diagnosed with RCC from 2008 to 2012. Diagnostic Computed Tomography images at the third lumbar vertebra (L3) were assessed for skeletal muscle index (SMI), skeletal muscle density (SMD), visceral adipose tissue index (VATI) and subcutaneous adipose tissue index (SATI). Clinical data was retrieved from medical records. Multivariable Cox regressions with restricted cubic splines were used to determine hazard ratios (HRs) and 95% confidence intervals (95%CIs) for 10-unit increases in body composition features with overall survival (OS) and recurrence-free survival (RFS). RESULTS: We included 719 stage I-III (of whom 254 (35.3%) died and 148 (21.9%) experienced recurrence) and 320 stage IV RCC patients (of whom 298 (93.1%) died). Median follow-up was 6.35 years (interquartile range; 1.41-8.23). For stage I-III, higher SMD was associated with better OS (men: HR 0.86; 95% CI 0.68-1.08; women: HR 0.69; 95% CI 0.50-0.95). Lower compared to median VATI was associated with worse OS for both men (HR 1.38; 95%CI 1.05-1.83 for VATI = 25) and women (HR 1.67; 95%CI 1.01-2.78 for VATI = 20). For stage IV, higher SMD and higher VATI were associated with better OS among men (HR 0.74; 95% CI 0.59-0.94 and HR 0.93; 95% CI 0.88-0.99, respectively). Results for women were similar but non-significant. No statistically significant associations were found for SMI or SATI. CONCLUSION: Higher SMD and higher VATI were marginally associated with better survival in RCC patients and might be useful for better prognostication. However, the added value to current prognostic scores needs to be investigated.

Greenness Assessment of Two Validated Stability-Indicating Chromatographic Methods for Estimating Modafinil Using the Analytical Eco-Scale.

BACKGROUND: Modafinil (MDF) is one of the drugs used for the treatment of narcolepsy. OBJECTIVE: This manuscript describes the development and validation of two chromatographic stability-indicating methods for MDF in the presence of its acid-induced degradation product. METHODS: MDF was degraded under different stress conditions and identification of the degradation product was performed using IR and mass spectroscopy. The first method involved TLC, in which plates precoated with silica gel G60 F254 were used and the developing system was dichloromethane- methanol (9:1, v/v). The second method was an eco-friendly (HPLC) method that utilized a C-18 column and ethanol-H2O (30:70, v/v) as a mobile phase with a flow rate of 1 mL/min and UV detection at 220 nm. RESULTS: Good linear relationships were obtained within the ranges 1-10 µg/band and 2-10 µg/mL for TLC-densitometry and HPLC, respectively. The obtained results were statistically compared with those of the official HPLC method and showed no significant difference with respect to their accuracy and precision at P = 0.05. Greenness scores represent excellent green analysis results in comparison with the reported studies. CONCLUSIONS: The proposed methods were validated according to ICH guidelines and were applied on bulk powder and pharmaceutical dosage forms using eco-friendly mobile phases in line with worldwide trends. HIGHLIGHTS: Chromatographic methods have been validated for the estimation of MDF in the presence of its degradation product. Clarification of the degradation pathway and elucidation of the structure were stated for the first time. This is the first published method using greenness assessment metrics for the analysis of MDF.

New algorithm for corneal densitometry assessment based on anterior segment optical coherence tomography.

PURPOSE: To describe a new algorithm to measure corneal densitometry based on images obtained by swept source anterior segment ocular coherence tomography (SS-AS-OCT) and establish standard densitometry values in a group of normal eyes. METHODS: A total of 111 healthy participants (195 eyes) were enrolled in this study. Using a MATLAB designed algorithm, the cornea was segmented into three layers: anterior, posterior and mid-stroma, and it was divided into two concentric areas, 0-2 and 2-4 mm, resulting in nine areas for the analysis. The mean corneal densitometry values were calculated and expressed as grayscale units (GSU). RESULTS: The mean age was 57 years (range 22-87), with 100 (51.3%) right eyes and 95 (48.7%) left eyes. The total corneal densitometry was 86.9 ± 12.1 GSU. The mid-stroma layer had the highest densitometry values, 87.4 ± 12.1 GSU, and the anterior layer had the lowest values, 81.9 ± 14.2 GSU. Densitometry differences between the anterior layer and the mid-stroma layer (P < 0.001), as well as the anterior layer and the posterior layer (P < 0.05) were statistically significant. The 0-2 mm concentric area had higher mean densitometry values, 97.8 ± 12.7 GSU, and the differences were significant compared to the 2-4 mm concentric area (P < 0.001). No correlation was found between the corneal densitometry values and gender or age. CONCLUSIONS: The new MATLAB segmentation algorithm for the analysis of corneal SS-AS-OCT images is capable to objectively assess corneal densitometry. We provide standard and normal data for better clinical and research approach.

Green NP-HPTLC and green RP-HPTLC methods for the determination of thymoquinone: A contrast of validation parameters and greenness assessment.

INTRODUCTION: Thymoquinone (TQ) is a naturally derived bioactive compound with several therapeutic effects. OBJECTIVE: The highly sensitive, rapid and green normal-phase (NP)/reversed-phase (RP) high-performance thin-layer chromatography (HPTLC) densitometry technique was developed for the determination of TQ in various plant extracts of different geographical regions, commercial capsules, creams and essential oils. METHODOLOGY: The NP densitometry estimation of TQ was performed using a cyclohexane-ethyl acetate (90:10, v/v) green solvent system, while, the RP-densitometry estimation of TQ was performed using an ethanol-water (80:20, v/v) green solvent system. The estimation of TQ was conducted at 259 nm. RESULTS: The NP and RP densitometry techniques were observed linear in the range of 25-1000 and 50-600 ng/band, respectively. All validation parameters such as accuracy, precision, robustness and sensitivity of NP/RP densitometry were observed within the limit of regulatory requirements and hence found to be suitable for the determination of TQ. The TQ contents were found to be highest in the Saudi Arabian extract followed by the Syrian extract, Indian extract, commercial capsules, commercial creams, Jordanian extract, Egyptian extract, Palestinian extract and commercial essential oils using NP densitometry. The TQ contents were found in same order using RP densitometry, but they were much lower than those recorded using NP densitometry. The Analytical GREEnness (AGREE) scores of NP and RP densitometry were found to be 0.82 and 0.84, respectively, suggesting an excellent greenness profile. CONCLUSIONS: Based on these results, NP/RP densitometry was found to be suitable for the pharmaceutical assay of TQ.

Assessment of Corneal Densitometry in Big-Bubble Dissection Versus Manual Dissection Deep Anterior Lamellar Keratoplasty.

PURPOSE: The aim of this study was to assess corneal densitometry and visual outcomes after big-bubble deep anterior lamellar keratoplasty (BB-DALK) and manual dissection deep anterior lamellar keratoplasty in patients with keratoconus. METHODS: This retrospective comparative observational study included 40 keratoconic patients who underwent DALK surgery: 22 eyes had BB-DALK (group I) and 18 eyes had failed BB technique and DALK was completed by manual dissection (group II). Best -corrected visual acuity (BCVA), corneal topographic parameters, residual stromal tissue thickness, and endothelial cell count were recorded at 1, 3, 6, and 12 months postoperatively. Densitometric analysis of different corneal layers and zones was performed using Scheimpflug tomography at each visit; values were recorded and compared between the 2 groups. RESULTS: At 1 and 6 months postoperatively, BCVA was better in group I than in group II, but with no statistically significant difference. At 12 months, the visual acuities became nearly similar in both groups (0.30 ± 0.13 vs. 0.30 ± 0.14 logarithm of the minimum angle of resolution, P = 0.888). Regarding corneal densitometric analysis, the recorded values for the posterior corneal layer were significantly higher in group II compared with group I at 3, 6, 9, and 12 months postoperatively in the 0- to 2-mm zone (P < 0.001) and the 2- to 6-mm zone (P = 0.029, 0.028, 0.001, and <0.001). CONCLUSIONS: Manual dissection DALK after failed BB technique may affect the interface stromal reflectivity up to 12 months postoperatively. However, this does not significantly affect the visual acuity in comparison with successful BB-DALK.

Lens densitometry for assessment and prediction of cataract progression after pars plana vitrectomy with C3F8-gas for retinal detachment.

PURPOSE: Lens opacification is a common complication after pars plana vitrectomy (PPV) and knowing its progression would facilitate consulting patients. The purpose of this study was to evaluate a quantitative model for lens-status-monitoring after PPV with C3F8 gas. Our model was evaluated in rhegmatogenous retinal detachment (RRD) patients of various age and lens densitometry (LD). METHODS: Data between March 2018 and March 2020 were evaluated retrospectively. LD measurements of the PentacamHR® Nucleus Staging mode (PNS) were used to quantify lens opacification over time. A mixed-effect regression model was designed, to enable LD predictions at any time postoperatively. Calculations were based on patient's age and baseline LD as dependent variables. Six patients were randomly excluded during model development, to be used for testing its power afterwards. RESULTS: 34 patients (male 19 [55.9%], female 15 [44.1%]) matched the inclusion criteria. Average age was 58.5 years (32-77;±4.3) and average follow-up was 7.2 months (3,4-23.1;±1,8). Mean baseline LD of the treated and fellow eye before surgery were 10.9% (8.7%-14.8%;±0.8) and 10.7% (8.5%-14.1%;±0.6), respectively. Using our prediction model, LD values for the six pre-selected patients closely match the observed data with an average deviation of 1.07%. CONCLUSIONS: Evaluation of age and baseline LD using a mixed-effect regression model might predict cataract progression in RRD patients treated with PPV and C3F8-gas. Such a tool could be considered during cataract surgery consultation in these patients.

Profile of patients who consult with internists for an osteoporosis assessment: The OSTEOMED registry.

BACKGROUND AND OBJECTIVES: Osteoporosis is considered a generalised skeletal disorder in which there is impaired bone resistance, which predisposes the individual to a greater risk of fracture. The aim of this cross-sectional study was to collect and present data on the main clinical characteristics of patients who consult medical internists in Spain. Understanding these characteristics can help in implementing action plans to improve these patients' care more effectively and efficiently. MATERIAL AND METHODS: Through an analysis of the Osteoporosis in Internal Medicine (OSTEOMED) registry, this study presents the main clinical characteristics of patients with osteoporosis who attended internal medicine consultations in 23 Spanish hospital centres between 2012 and 2017. We analysed the reasons for the consultations, the densitometric values, the presence of comorbidities, the prescribed treatment and other lifestyle-related factors. RESULTS: In total, 2024 patients with osteoporosis were assessed (89.87% women, 10.13% men). The patients' mean age was 64.1±12.1 years (women, 64.7±11.5 years; men, 61.2±14.2 years). There was no significant difference between the sexes in their history of recent falls (9.1% and 6.7%); however, there were significant differences in the daily intake of calcium from milk products (553.8±332.6mg for women vs. 450.2±303.3mg for men; p<.001) and in the secondary causes of osteoporosis (13% of men vs. 6.5% of women; p<.001). In the sample, there were 404 fractures (20%), with a notable number of confirmed vertebral fractures (17.2%, 35.6% in men vs. 15.2% in women; p<.001). A large portion of the patients did not undergo the indicated treatment and presented low levels of physical activity and sun exposure. A significant percentage of the patients presented associated comorbidities, the most common of which were hypertension (32%) and dyslipidaemia (28%). CONCLUSIONS: These results define the profile of patients with osteoporosis who attend internal medicine consultations in Spain. The results also show the multisystemic character of this condition, which, along with its high prevalence, determine that the specific internal medicine consultations dedicated to managing the condition are the appropriate place for caring for these patients.

A cost-effective and sensitive TLC-densitometric identification of meloxicam.

The influence of different chromatographic conditions and the process of spot visualization on determining the limit of detection as well as quantification (LOD and LOQ) of meloxicam by TLC-densitometric technique was estimated. Of all chromatographic conditions tested, the lowest limiting values, thus the best sensitivity, in the NP-TLC system was achieved on silica gel 60F254 and neutral aluminum oxide plates developed with the mobile phase consisting of ethyl acetate/toluene/n-butylamine (2:2:1, V/V/V). In the case of the RP-TLC method, a mixture of methanol/water (8:2, V/V) enabled densitometric detection of meloxicam at the lowest concentration level on RP-8F254 and RP-18F254 plates. Additionally, the smallest LOD value of meloxicam ensured crystalline violet and gentian violet as visualization agents on silica gel 60F254 and neutral aluminum oxide 150F254 plates, resp. Comparison of the densitometrically obtained spectra of meloxicam drug and its standard after the use of appropriate visualization agents could be a good and cheap alternative tool for the identification of meloxicam as an active pharmaceutical ingredient.

Avaliação da saúde óssea em pacientes com anorexia nervosa e bulimia nervosa / Bone health assessment in patients with anorexia nervosa and bulimia nervosa

Introdução: Anorexia nervosa (AN) e bulimia nervosa (BN) são transtornos alimentares (TA), cujos sintomas típicos de restrição alimentar, exercícios físicos excessivos, vômitos auto-induzidos e abuso de laxantes e diuréticos podem resultar em severas complicações clínicas. Mulheres com AN e BN apresentam risco elevado para osteoporose, osteopenia e fraturas, associado com baixo peso, atividade física excessiva, história e duração da doença, amenorreia, perda de força muscular e insuficiência de vitamina D. Objetivo: Avaliar a saúde óssea e a composição corporal de mulheres adultas com diagnóstico de AN e BN atual ou prévio. Métodos: estudo transversal incluindo 53 mulheres adultas (18-49 anos) com diagnóstico atual ou pregresso de AN (n=25) ou BN (n=28). Foi realizada absorciometria com raios-X de dupla energia (DXA) para mensuração da densidade mineral óssea (DMO) (total, coluna lombar e colo do fêmur), massa gorda e massa magra e seus índices ajustados pela estatura; administração de diluição isotópica de deutério (D2O) para determinação de água corporal total e massa magra, e teste de prensão palmar para avaliação da força muscular. A determinação sérica das concentrações de glicose, insulina (cálculo de HOMA-IR), colesterol total e frações (LDL-c, HDL-c e VLDL-C), triglicérides e 25-hydroxyvitamin D (25(OD)D) foram realizadas em amostra de sangue obtida após jejum de 12 horas. Foram aplicados questionários sobre história da doença, uso de suplementos, atividade física habitual e sintomas do TA. Análises estatísticas incluíram testes T Independente, ANOVA, Qui Quadrado, correlação linear de Pearson, modelos de regressão linear univariados e múltiplos e análise de Bland-Altman. Resultados estão apresentados em média, desvio-padrão, frequências e intervalo de confiança de 95%. Revisão sistemática e meta-análise da DMO em indivíduos com TA em comparação a controles saudáveis foi realizada de acordo com o PRISMA guidelines. Resultados: Mulheres com AN apresentaram menor DMO de corpo total [1.09 g/cm2 (0.07) vs BN: 1.18 g/cm2 (0.12); p<0.01] e do colo do fêmur [0.95 g/cm2 (0.13) vs BN: 1.05 g/cm2 (0.16); p<0.01] em comparação com BN. Mulheres com AN apresentaram menor gordura corporal, razão androide/ginoide, tecido adiposo visceral, massa magra e maior percentual de massa magra em comparação àquelas com BN. Comparação entre DXA e D2O mostrou nenhuma diferença significante para gordura corporal (massa, percentual e índice de massa/estatura2) e massa magra (massa e índice de massa/estatura2). Possível viés sistemático do DXA em superestimar gordura corporal e massa magra, exceto para o índice de massa livre de gordura (IMLG), foi relacionado com o diagnóstico de BN, estado de hidratação e atividade física. DMO total foi positivamente associada com gordura corporal (Modelo DXA: ß=0.59; p=0.007; Modelo D2O: ß=0.59; p<0.001) e força muscular (Modelo DXA: ß=0.32; p=0.013). DMO da coluna foi negativamente associada com duração da amenorreia (Modelo DXA: ß=-0.32; p=0.027; Modelo D2O: ß=-0.38; p=0.024). A DMO do colo do fêmur foi associada com gordura corporal (Modelo D2O: ß=0.37; p=0.038) e massa magra (Modelo D2O: ß=0.43; p=0.025). Não houve efeito da duração da doença e atividade física na DMO. Foram observadas diferenças entre os TA nos valores de HOMA-IR [AN: 1.3 (0.8) vs BN: 2.0 (1.2); p<0.05] e HDL-c [AN: 76.6mg/dL (13.2) vs BN: 61.9 mg/dL (16.3); p<0.05]. Inadequação de 25(OH)D (<30ng/mL) foi observada na AN (100%) e na BN (72%). Destacam-se as associações independentes de HOMA-IR e LDL-c com a DMO do colo do fêmur em mulheres com AN (R2=0.45; p<0.00; HOMA ß=0.503; LDL-c: ß=0.398). Na meta-análise (n=42 estudos), a DMO (total, coluna, quadril e fêmur) foi menor na AN e a DMO (total e coluna) foi menor BN (principalmente com história de AN) em comparação aos controles saudáveis. Conclusão: mulheres com AN e BN com história de AN são mais susceptíveis às perdas de massa óssea. É importante que indivíduos com AN ou história de AN tenham sua saúde óssea avaliada, independente do diagnóstico atual. Recomenda-se a utilização do IMLG e o desenvolvimento de protocolos específicos para realização da avaliação da composição corporal pelo DXA nessa população. A avaliação da saúde óssea deve considerar composição corporal, história da doença, função menstrual e estado de hidratação. A inclusão de teste de força e análise de parâmetros bioquímicos pode auxiliar na identificação de indivíduos que apresentam maior necessidade de exames específicos.

Background: Anorexia nervosa (AN) and bulimia nervosa (BN) are eating disorders (ED) whose typical symptoms of food restriction, excessive exercise, self-vomit and misuse of laxatives and diuretics can lead to severe clinical complications. Women with AN and BN have increased risk of developing osteopenia, osteoporosis and fractures, associated with low weight, low physical activity, history and duration of the disease, amenorrhea, lack of muscle strength and vitamin D insufficiency. Aim: to assess bone health and body composition of women with current or previous AN and BN. Methods: cross-sectional study including 53 adult (18-49 years) with current or previous diagnosis of AN (n=25) or BN (n=28). Dual-energy x-ray absorptiometry (DXA) was performed to measure total, lumbar spine and femoral neck BMD, fat mass and lean mass; and administration of deuterium oxide (D2O) solution to determine total body water and lean mass. Serum determinations of glucose, insulin (HOMA-IR calculation), total cholesterol and fractions (LDL-c, HDL-c and VLDL-C), triglycerides, and 25-hydroxyvitamin D (25(OD)D were obtained after a 12-hour fasting blood test. Questionnaires about lifestyle, clinical history of the disease, use of supplements, physical activity and ED symptoms were applied. Statistical analyses included Independent T, ANOVA, chi-Square, Pearson's linear correlation tests, univariate and multivariate linear regressions and Bland-Altman analysis. Results are presented in means, standard deviation, frequencies, and 95% confidence interval. Systematic review and meta-analysis of BMD in individuals with ED in comparison to healthy controls was performed according to PRISMA guidelines. Results: Women with AN had lower total DMO [1.09 g/cm2 (0.07) vs BN: 1.18 g/cm2 (0.12); p<0.01] and femoral neck BMD [0.95 g/cm2 (0.13) vs BN: 1.05 g/cm2 (0.16); p<0.01] than women with BN. Compared to BN, women with AN presented less fat mass, android/gynoid ratio, visceral adipose tissue, lean mass and higher lean mass percentage. DXA and D2O dilution comparison showed absence significant difference for body fat (mass, percentage and index) and lean mass (mass and index). Possible bias of DXA in overestimating fat and lean mass, except for lean mass index (LMI) was related to BN diagnosis, hydration status and physical activity. Total BMD was positively associated with body fat (Model DXA: ß=0.59; p=0.007; Model D2O: ß=0.59; p<0.001) and muscle strength (Model DXA: ß=0.32; p=0.013). Lumbar spine BMD was negatively associated with duration of amenorrhea (Model DXA: ß=-0.32; p=0.027; Model D2O: ß=-0.38; p=0.024). Femoral neck BMD associated with body fat (Model D2O: ß=0.37; p=0.038) and lean mass (Model D2O: ß=0.43; p=0.025). Illness duration and physical activity did not present effect on BMD. Differences were observed for HOMA-IR [AN: 1.3 (0.8) vs BN: 2.0 (1.2); p<0.05] e HDL-c [AN: 76.6mg/dL (13.2) vs BN: 2.0 mg/dL (1.2); p<0.05]. 25(OH)D (<30ng/mL) inadequacy was observed in AN (100%) and BN (72%). HOMA-IR and LDL-c were independently associated with femoral neck BMD in women with AN (R2=0.45; p<0.00; HOMA ß=0.503; LDL-c: ß=0.398). In the meta-analysis (n=42 studies), BMD (total, spine, hip and femur) were lower in AN and BMD (total and spine) lower in BN than in healthy controls. Conclusion: Women with AN and BN and a history of AN are prone to bone loss. It is important that individuals with AN or a history of AN have their bone health assessed, irrespective of the current diagnosis. The use of the LMI and the development of specific protocols to carry out the assessment of body composition by DXA are recommended for this population. Bone health assessment should consider body composition, disease history, menstrual function, and hydration status. The inclusion of grip strength test and analysis of biochemical parameters can help identify individuals who have a greater need for specific tests.

Assessment of cataract forming effect of diabetes in young adults by lens densitometer.

PURPOSE: To investigate the effect of the diabetes on cataract formation by Pentacam Scheimpflug topography system. MATERIALS AND METHODS: Thirty diabetic patients and thirty-five healthy control subjects were included in the study. Exclusion criteria were smoking, high refractive error, any systemic disease or drug usage associated with cataract formation and to have diabetic retinopathy. The duration of diabetes and HbA1c level were recorded. A comprehensive ophthalmologic examination was performed in all cases. Pentacam (Oculus, Wetzlar, Germany) three-dimensional lens densitometer module was used to measure density of anterior, nuclear and posterior lens regions. RESULTS: Mean age of group 1 and group 2 was 37.80 ± 5.51 years and 36.51 ± 3.77 years, respectively. There were not any difference between groups in the means of age and sex (P = .271; P = .700). The mean duration of diabetes in group 1 was 4.23 ± 3.71 years (6 months-10 year). The mean HbA1c level was 8.12 ± 2.07% (5.4-12.7%). Anterior, nuclear and posterior mean lens densitometry measurements were significantly higher in group 1 (diabetic group) than group 2 (control group) [(8.90 ± 0.59%; 8.05 ± 0.72% P = < .001), (7.52 ± 0.31%; 7.00 ± 0.59% P = < .001), (7.25 ± 0.31%; 6.90 ± 0.73% P = .006), respectively]. CONCLUSION: Diabetes may have cataractous effect in anterior, nuclear and posterior regions of the lens.

Assessment of Corneal Haze After PRK and the Effect of Sutureless Amniotic Membrane Graft by Corneal Densitometry.

PURPOSE: To assess whether densitometry analysis appropriately monitors the development of haze in myopic patients after photorefractive keratectomy (PRK) when compared to subjective slit-lamp haze grade examinations, and whether sutureless cryo-preserved amniotic membrane reduced postoperative haze development when compared to the standard bandage contact lens. METHODS: In this retrospective cohort at the Center for Refractive Surgery, Walter Reed National Military Medical Center, a secondary analysis of prospectively collected data was performed. In the prospective study, participants underwent PRK for myopia. Postoperatively, a standard bandage contact lens was applied to the dominant eye and a sutureless cryo-preserved amniotic membrane graft to the nondominant eye. Participants were evaluated at 1, 3, and 6 months postoperatively for haze formation and corneal densitometry using slit-lamp biomicroscopy and Scheimpflug imaging, respectively. RESULTS: Densitometry measurements at 6 months postoperatively were positively and significantly associated with the presence or absence of haze as assessed by slit-lamp examination in 39 patients (78 eyes; age range: 21 to 44 years). Eyes with increased densitometry measurements had 2.3 to 3.4 times the odds (P ⩽ .014) of having clinical haze on slit-lamp examination. Eyes with the amniotic membrane graft showed a positive correlation with increased corneal densitometry throughout most layers of the cornea. CONCLUSIONS: Densitometry analysis appears to be a useful tool to supplement slit-lamp examination in monitoring haze development after PRK. The amniotic membrane failed to show a reduction in corneal densitometry in myopic eyes after PRK. [J Refract Surg. 2020;36(5):293-299.].

Novel HPTLC densitometric methods for determination of tamsulosin HCl and tadalafil in their newly formulated dosage form: Comparative study and green profile assessment.

A promising combination of tamsulosin HCl and tadalafil has recently been introduced for treating two prevalent and associated urological disorders: benign prostate hyperplasia and erectile dysfunction. Novel HPTLC methods were designed and validated for assaying the cited drugs in their challenging combined formulation. Separation was achieved using HPTLC silica gel 60 F254 plates as a stationary phase with a densitometric measurement at 280 nm. The proposed methods with two different chromatographic systems were successfully applied: a conventional mixture (method I) of ethyl acetate-toluene-methanol-ammonia (5:3:2:0.5, by volume) and a greener one (method II) with ethyl acetate-ethanol-ammonia (8:2:0.1, by volume). The two methods were evaluated through a comparative study in terms of selectivity, tailing factor, developing time and concentration ranges. The greenness profile for each method was then appraised with several green guides, namely GlaxoSmithKline solvent sustainability guide, Environmental, Health and Safety (EHS) tool, National Environmental Method Index (NEMI) and Eco-scale. Moreover, method specificity and peak homogeneity were evaluated by peak purity assessment using the winCATS® software spectral correlation tool. The methods have potential for being simple, fast, economic and selective, and the greener one could be a good option for sustainable analysis of the drugs.

Assessment of Risk Factors for Fractures in Patients with Type 2 Diabetes over 60 Years Old: A Cross-Sectional Study from Northeast China.

AIMS: Previous evidence has demonstrated an increased fracture risk among the population with type 2 diabetes mellitus (T2DM). This study investigated the prevalence of bone fractures in elderly subjects (with and without type 2 diabetes) and identified any fracture risk factors, especially the risk factors for common known fractures in particular diabetic populations. METHODS: This cross-sectional study was conducted with community-dwelling people over 60 years old in nine communities from the city of Shenyang, which is the capital of Northeast China's Liaoning Province. A total of 3430 elderly adults (2201 females, mean ± standard deviation age 68.16 ± 6.1 years; 1229 males, 69.16 ± 6.7 years) were included. Our study measured the heel bone mineral density (BMD) and used the timed "up and go" (TUG) test and other indicators. In addition, we performed logistic regression analysis to explore the risk factors for fractures in the general population and the diabetic population and to analyze the differences. RESULTS: The results revealed that a total of 201 elderly persons (5.8%), with an average age of 70.05 ± 6.54 years, suffered from a history of fragility fractures, which affected more females (74.6%) than males (p = 0.001). The prevalence of fractures in the T2DM population was 7.3%, which was much higher than the 5.2% in non-T2DM population (p = 0.001). The prevalence of fractures in the T2DM population was 7.3%, which was much higher than the 5.2% in non-T2DM population (p = 0.001). The prevalence of fractures in the T2DM population was 7.3%, which was much higher than the 5.2% in non-T2DM population (p = 0.001). The prevalence of fractures in the T2DM population was 7.3%, which was much higher than the 5.2% in non-T2DM population (T-score≤-2.5 (OR 1.750) were independent risk factors for fragility fractures in the non-T2DM population, but they were not risk factors in the T2DM population. CONCLUSIONS: This study found that low BMD and slow TUG time were independent risk factors for fractures in non-T2DM patients, while no associations were found in the T2DM population. Patients with T2DM have a higher risk for fractures even when they have sufficient BMD and a short TUG time. TUG and BMD underestimated the risk for fractures in the T2DM population.

Chromatographic determination of sulfasalazine and its active metabolites: greenness assessment and application to spiked human plasma.

Green TLC-densitometric and RP-HPLC methods were developed and validated for the determination of the active prodrug sulfasalazine (SZ), its active metabolite mesalazine (MZ) and the major active metabolite of mesalazine, N-acetyl-5-aminosalicylic acid (AS). In the developed TLC-densitometric method, chromatographic separation was carried out on TLC silica gel plates 60 F254 using a developing system consisting of ethyl acetate-methanol-ammonia solution 33% (8:2.5:0.3, by volume) and then scanning the separated bands at 215 nm using hydrochlorothiazide as an internal standard with linearity ranges of 0.4-3, 0.4-2.4 and 0.3-2 for SZ, MZ and AS, respectively. The developed RP-HPLC method depended on chromatographic separation using a C18 column with a solvent mixture of methanol-aqueous acetic acid solution (pH 5) as a mobile phase with gradient elution mode and UV scanning at 243 nm using pyrazinamide as internal standard with linearity ranges of 5-50, 5-40, and 3-20 for SZ, MZ and AS, respectively. US Food and Drug Administration guidelines were followed during validation of the methods. The greenness of the developed methods was estimated using the greenness profile and the Eco-Scale approach. Both methods passed the four quadrants of the greenness profile and had Eco-Scale score ˃75, thus they were considered to be green according to these approaches.

Assessment of corneal topographic, tomographic, densitometric, and biomechanical properties of Fabry patients with ocular manifestations.

PURPOSE: To investigate whether cornea verticillata affects corneal topography, tomography, densitometry, or biomechanics of Fabry patients with ocular manifestations and to compare these results with those obtained from healthy subjects. METHODS: This prospective, cross-sectional study included 23 Fabry patients (Fabry group) with cornea verticillata and the 37 age- and sex-matched healthy subjects (control group). After comprehensive ophthalmological examinations, corneal topography, tomography, and densitometry measurements were taken using Pentacam HR and corneal biomechanics were captured via Corvis ST for all participants. RESULTS: All the investigated topographic and tomographic values were similar in the eyes with Fabry disease (FD) and the controls (P > 0.05). The corneal densitometry values of patients with FD were statistically significantly higher in all the concentric zones and layers, except posterior 0-2 mm and posterior 2-6 mm zones, compared to the controls (P < 0.05). The mean values of A1 velocity, A2 velocity, deformation amplitude ratio, Corvis biomechanical index, tomographic and biomechanical index, and Stiffness parameter at the first applanation in the Fabry group were statistically significantly different compared to control group (P < 0.05). However, the mean values of A1 length, A2 length, and the biomechanically corrected intraocular pressure were similar between the groups (P = 0.317, P = 0.819, and P = 0.468; respectively). CONCLUSION: Although cornea verticillata associated with FD is not considered to affect vision, it is associated with increased light backscattering and reduced corneal transparency as well as altered corneal biomechanical properties.

Assessment of corneal and lens clarity in children with Wilson disease.

PURPOSE: To investigate the effect of copper accumulation on corneal and lens clarity in children with Wilson disease (WD) compared to healthy children. METHODS: This multicenter cross-sectional study included 24 subjects with WD and 25 age-matched controls. Clinical and laboratory characteristics of the WD subjects were recorded. The Pentacam HR imaging system was used both for lens densitometry and corneal densitometry. RESULTS: Corneal densitometry values were higher in the posterior 6-10 mm (P = 0.021), posterior 10-12 mm (P < 0.001), posterior total diameter (P = 0.037), total thickness 10-12 mm (P = 0.032), and total thickness 6-10 mm zones and layers (P = 0.040) in the WD eyes than in control eyes. The lens densitometry values of zone 1 were higher in WD eyes (P < 0.001). There was a significant relationship between corneal densitometry values in the posterior 10-12 mm zones (P = 0.012; r = 0.527) and the duration of WD and liver copper content (P = 0.016; r = 0.507). A statistically significant correlation was also detected between lens densitometry values in zone 1 and WD duration (P = 0.018; r = 0.426). CONCLUSION: In this study cohort, children with WD had decreased corneal and lens clarity even in cases without Kayser-Fleischer rings and sunflower cataracts. Densitometry measurements using Scheimpflug imaging provided detection of corneal and lens involvement in the early stages of WD.