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Robert Lehmann,1 Satish Modi,2 Bret Fisher,3 Magda Michna,4 Michael Snyder5 1Lehmann Eye Center, Nacogdoches, TX, 2Seeta Eye Center, Poughkeepsie, NY, 3The Eye Center of North Florida, Panama City, FL, 4Department of Clinical Trial Management, Alcon Laboratories, Inc., Fort Worth, TX, 5Cincinnati Eye Institute, Cincinnati, OH, USA Purpose: The purpose of this study was to evaluate the clinical outcomes of apodized diffractive +3.0 D multifocal toric intraocular lens (IOL) implantations in subjects with preoperative corneal astigmatism.Patients and methods: This was a prospective cohort study conducted at 21 US sites. The study population consisted of 574 subjects, aged ≥21 years, with preoperative astigmatism 0.75–2.82 D, and potential postoperative visual acuity (VA) ≥0.2 logMAR, undergoing bilateral cataract removal by phacoemulsification. The intervention was bilateral implantation of aspheric apodized diffractive +3.0 D multifocal toric or spherical multifocal nontoric IOLs. The main outcome measures were monocular uncorrected near and distance VA and safety at 12 months.Results: A total of 373/386 and 182/188 subjects implanted with multifocal toric and nontoric IOLs, respectively, completed 12-month follow-up after the second implantation. Toric IOLs were noninferior in monocular uncorrected distance (4 m) and near (40 cm) VA but had >1 line better binocular uncorrected intermediate VA (50, 60, and 70 cm) than nontoric IOLs. Toric IOLs reduced cylinder to within 0.50 D and 1.0 D of target in 278 (74.5%) and 351 (94.1%) subjects, respectively. Mean ± standard deviation (SD) differences between intended and achieved axis orientation in the first and second implanted eyes were 5.0°±6.1° and 4.7°±4.0°, respectively. Mean ± SD 12-month IOL rotations in the first and second implanted eyes were 2.7°±5.8° and 2.2°±2.7°, respectively. No subject receiving toric IOLs required secondary surgical intervention due to optical lens properties.Conclusion: Multifocal toric IOLs were noninferior to multifocal nontoric IOLs in uncorrected distance and near VAs in subjects with preexisting corneal astigmatism and effectively corrected astigmatism of 0.75–2.82 D. Keywords: AcrySof® IQ ReSTOR, corneal astigmatism, phacoemulsification, target cylinder, axis orientation, IOL rotation lens, visual acuity

Background: Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods: Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results: Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions: In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures. © 2013 Collard et al.; licensee BioMed Central Ltd.

Four dynamic regional climate models (RCMs) and one statistical downscaling approach were used to downscale 10 years of historical climate in California. To isolate possible limitations of the downscaling methods, we used initial and lateral boundary conditions from the NCEP global reanalysis. Results of this downscaling were compared to observations and to an independent, fine-resolution reanalysis (NARR). This evaluation is preparation for simulations of future-climate scenarios, the second phase of this CEC scenarios project. Each model has its own strengths and weaknesses, which are reported here. In general, the dynamic models perform as well as other state-of-the-art dynamical regional climate models, and the statistical model has comparable or superior skill, although for a very limited set of meteorological variables. As is typical, the dynamical models have the most trouble simulating clouds, precipitation, and related processes, especially snow. This suggests that the weakest aspects of the models are parameterized subgrid scale processes, the hydrological cycle, and land surface processes. However, the resulting probabilistic ensemble simulations result in reduced model uncertainty and a better understanding of model spread.