The Berkeley Contact Lens Extended Wear Study. Part I : Study design and conduct.

ObjectiveThe primary aim of the Berkeley Contact Lens Extended Wear Study (CLEWS) was to test the hypotheses that extended wear of rigid gas-permeable (RGP) contact lenses with greater oxygen permeability (Dk) reduces the incidence of contact lens-associated keratopathy (CLAK) and increases the survival rate in RGP extended wear (EW). In this article we describe the clinical trial design in detail, present the results of subject recruitment and retention, and provide the baseline demographic and ocular characteristics of the CLEWS subjects, whose data will be analyzed to address the study aims in a companion article.DesignA randomized, concurrently controlled clinical trial.InterventionSubjects were fitted with day wear (DW) high-Dk RGP lenses and then adapted to EW. Subjects who adapted to EW were then randomly assigned to either high- or medium-Dk RGP lenses for 12 months of 6-nights/week EW.Main outcome measuresSlit-lamp assessment and grading of 17 possible keratopathies, measurement of refractive error and corneal curvature, and symptoms. Follow-up data were collected every 3 months.ResultsFrom 545 subjects entering the DW adaptation phase, 201 adapted to EW and were randomly assigned to medium- or high-Dk lenses for 12 months of EW. The baseline characteristics of the two study groups were similar and did not differ from the 344 DW subjects who failed to adapt to EW. The distributions of oxygen transmissibility for the two study groups were disjoint, indicating that each group received distinctly different levels of hypoxia.ConclusionsWe show that CLEWS was appropriately designed to address the study hypotheses, was conducted with regard for the safety of the subjects, and adhered to rigorous protocols designed to control for bias and ensure the integrity of study data. We establish the internal validity of between-group statistical comparisons and characterize our study population to permit informed evaluation of the applicability of our results to the contact lens-wearing population in general

The Berkeley Contact Lens Extended Wear Study. Part II : Clinical results.

ObjectiveTo describe the principal clinical outcomes associated with 12 months use of rigid gas-permeable (RGP) extended wear contact lenses and address two primary study questions: (1) does extended wear (EW) of high oxygen transmissibility (Dk/t) RGP lenses reduce the incidence of ocular complications, and (2) does the wearing of high-Dk/t lenses reduce the rate of failure to maintain 6-night RGPEW over 12 months?DesignA randomized, concurrently controlled clinical trial.InterventionSubjects who adapted to EW with high Dk (oxygen permeability) RGP lenses were randomized to either high Dk or medium-Dk RGP lenses for 12 months of 6-night EW.Main outcome measuresContact lens-associated keratopathies (CLAK), changes in refractive error and corneal curvature, and survival in EW.ResultsTwo hundred one subjects were randomized to medium or high-Dk lenses for 12 months of EW. Sixty-two percent of the subjects in each group completed 12 months of EW; however, the probability of failure was significantly greater for the medium-Dk group. Although the risk of complications was similar for the two groups, the number of CLAK events that led to termination were 16 versus 5 for the medium-Dk and high-Dk groups, respectively. This suggests that the type of adverse response or the inability to reverse an adverse event was different for the group being exposed to the lower oxygen dose.ConclusionsThe level of oxygen available to the cornea has a significant impact on maintaining successful RGP extended contact lens wear, but not on the initial onset of CLAK. The number of clinical events leading to termination was substantially higher for the medium Dk group, which suggests that corneal hypoxia is an important factor in the development of CLAK. Although overnight contact lens wear should be recommended with caution and carefully monitored for early detection of ocular complications, it appears that high-Dk RGP lenses can be a safe and effective treatment for correction of refractive error for most individuals who can adapt to EW

Influence of antisynthetase antibodies specificities on antisynthetase syndrome clinical spectrum time course

Antisynthetase syndrome (ASSD) is a rare clinical condition that is characterized by the occurrence of a classic clinical triad, encompassing myositis, arthritis, and interstitial lung disease (ILD), along with specific autoantibodies that are addressed to different aminoacyl tRNA synthetases (ARS). Until now, it has been unknown whether the presence of a different ARS might affect the clinical presentation, evolution, and outcome of ASSD. In this study, we retrospectively recorded the time of onset, characteristics, clustering of triad findings, and survival of 828 ASSD patients (593 anti-Jo1, 95 anti-PL7, 84 anti-PL12, 38 anti-EJ, and 18 anti-OJ), referring to AENEAS (American and European NEtwork of Antisynthetase Syndrome) collaborative group's cohort. Comparisons were performed first between all ARS cases and then, in the case of significance, while using anti-Jo1 positive patients as the reference group. The characteristics of triad findings were similar and the onset mainly began with a single triad finding in all groups despite some differences in overall prevalence. The "ex-novo" occurrence of triad findings was only reduced in the anti-PL12-positive cohort, however, it occurred in a clinically relevant percentage of patients (30%). Moreover, survival was not influenced by the underlying anti-aminoacyl tRNA synthetase antibodies' positivity, which confirmed that antisynthetase syndrome is a heterogeneous condition and that antibody specificity only partially influences the clinical presentation and evolution of this condition

Risposta di talee di Salix alba L. ad elevate concentrazioni di zinco allevate in coltura idroponica e in vaso.

Negli ultimi decenni, la capacità delle specie vegetali di accumulare elementi potenzialmente tossici nei loro organi è stata proposta come strumento idoneo nella bonifica di siti inquinati. La risposta funzionale in Salix alba L., sottoposta ad elevate concentrazioni di zinco, è stata valutata attraverso misure di scambio gassoso e fluorescenza della clorofilla a, in due esperimenti a breve termine condotti in condizioni di crescita controllate, in coltura idroponica (3000 µM ZnCl2) e in vaso (3000 mg/kg ZnCl2). La quantità di metallo assorbita negli organi vegetali (foglie, fusto e radici) e quella presente nel substrato di crescita (terreno e soluzione di crescita) è stata valutata mediante spettrofotometria ad assorbimento atomico (AAS); sono stati inoltre calcolati i fattori di bioaccumulo (BAF) e traslocazione (TF). In entrambi gli esperimenti, è stata osservata una riduzione significativa degli scambi gassosi (fotosintesi netta e conduttanza stomatica) e un maggiore accumulo del metallo nella porzione radicale. Tuttavia, le talee cresciute in soluzione idroponica, con apporto costante di Zn, hanno riportato effetti sulla funzionalità del processo fotosintetico (regione J-I-P del transient di fluorescenza) più marcati e fattori di bioaccumulo (BAF) elevati rispetto alle talee cresciute in vaso, dove la minore disponibilità del contaminante ha limitato il processo di fitoestrazione. La ridotta traslocazione del contaminante alle porzioni epigee osservata in entrambi gli esperimenti indicano un potenziale impiego di Salix alba in processi di fitostabilizzazione dei metalli pesanti in suoli ad elevato grado di inquinamento

Risposta ecofisiologica all’assorbimento dello zinco in talee di Salix alba L. allevate in coltura idroponica

Il crescente fenomeno dell’inquinamento da metalli pesanti nelle acque e nei suoli richiede l’individuazione di strategie di risanamento impiegabili su ampie superfici e a costi contenuti. Le potenzialità di accumulo e tolleranza ai metalli pesanti di diverse specie di salice risultano interessanti per applicazioni in tecnologie di fitorimedio. In un esperimento a breve termine talee di Salix alba L., cresciute in coltura idroponica, sono state sottoposte ad elevate concentrazioni di zinco (3000M), al fine valutare gli effetti del metallo sull’attività fisiologica della pianta e caratterizzare le capacità di fitoestrazione di tale specie. La risposta funzionale è stata valutata a livello fogliare, tramite analisi non distruttive e non invasive: misure di scambi gassosi, fluorescenza diretta della clorofilla “a” e contenuto relativo di pigmenti fotosintetici. È stata calcolata la quantità di metallo assorbito nella biomassa (foglie, fusto e radici) attraverso spettroscopia ad assorbimento atomico (AAS) e sono stati determinati i fattori di bioaccumulo (BAF) e traslocazione (TF). I risultati ottenuti dalle misure di scambio gassoso, evidenziano una riduzione significativa della fotosintesi netta e della conduttanza stomatica, nei giorni successivi alla somministrazione del metallo, dovuto ad una limitazione di tipo stomatico. I principali parametri della fluorescenza (test OJIP) mostrano una riduzione dell’efficienza del trasporto elettronico e della performance fotosintetica, indice di un alterazione dell’apparato fotosintetico. Infine, dalle analisi delle concentrazioni del metallo negli organi della pianta, è emerso come il maggior accumulo di zinco è stato rinvenuto nelle radici, con scarso traslocazione e allocazione nelle porzioni epigee. Pertanto, anche se S. alba non rientra tra le specie fitoestrattrici, per la scarsa traslocazione del metallo alle foglie (TF<1), risulta tollerante ad elevate concentrazioni di zinco e può essere utilizzata nei processi di fitostabilizzazione per la bonifica di siti inquinati

The Berkeley Contact Lens Extended Wear Study. Part II : Clinical results.

ObjectiveTo describe the principal clinical outcomes associated with 12 months use of rigid gas-permeable (RGP) extended wear contact lenses and address two primary study questions: (1) does extended wear (EW) of high oxygen transmissibility (Dk/t) RGP lenses reduce the incidence of ocular complications, and (2) does the wearing of high-Dk/t lenses reduce the rate of failure to maintain 6-night RGPEW over 12 months?DesignA randomized, concurrently controlled clinical trial.InterventionSubjects who adapted to EW with high Dk (oxygen permeability) RGP lenses were randomized to either high Dk or medium-Dk RGP lenses for 12 months of 6-night EW.Main outcome measuresContact lens-associated keratopathies (CLAK), changes in refractive error and corneal curvature, and survival in EW.ResultsTwo hundred one subjects were randomized to medium or high-Dk lenses for 12 months of EW. Sixty-two percent of the subjects in each group completed 12 months of EW; however, the probability of failure was significantly greater for the medium-Dk group. Although the risk of complications was similar for the two groups, the number of CLAK events that led to termination were 16 versus 5 for the medium-Dk and high-Dk groups, respectively. This suggests that the type of adverse response or the inability to reverse an adverse event was different for the group being exposed to the lower oxygen dose.ConclusionsThe level of oxygen available to the cornea has a significant impact on maintaining successful RGP extended contact lens wear, but not on the initial onset of CLAK. The number of clinical events leading to termination was substantially higher for the medium Dk group, which suggests that corneal hypoxia is an important factor in the development of CLAK. Although overnight contact lens wear should be recommended with caution and carefully monitored for early detection of ocular complications, it appears that high-Dk RGP lenses can be a safe and effective treatment for correction of refractive error for most individuals who can adapt to EW

Real-World Analysis of Outcomes and Economic Burden in Patients with Chronic Kidney Disease with and without Secondary Hyperparathyroidism among a Sample of the Italian Population

This real-world analysis evaluated the clinical and economic burden of non-dialysis-dependent CKD patients with and without secondary hyperparathyroidism (sHPT) in Italy. An observational retrospective study was conducted using administrative databases containing a pool of healthcare entities covering 2.45 million health-assisted individuals. Adult patients with hospitalization discharge diagnoses for CKD stages 3, 4, and 5 were included from 1 January 2012 to 31 March 2015 and stratified using the presence/absence of sHPT. Of the 5710 patients, 3119 were CKD-only (62%) and 1915 were CKD + sHPT (38%). The groups were balanced using Propensity Score Matching (PSM). Kaplan-Meier curves revealed that progression to dialysis and cumulative mortality had a higher incidence in the CKD + sHPT versus CKD-only group in CKD stage 3 patients and the overall population. The total direct healthcare costs/patient at one-year follow-up were significantly higher in CKD + sHPT versus CKD-only patients (EUR 8593 vs. EUR 5671, p &lt; 0.001), mostly burdened by expenses for drugs (EUR 2250 vs. EUR 1537, p &lt; 0.001), hospitalizations (EUR 4628 vs. EUR 3479, p &lt; 0.001), and outpatient services (EUR 1715 vs. EUR 654, p &lt; 0.001). These findings suggest that sHPT, even at an early CKD stage, results in faster progression to dialysis, increased mortality, and higher healthcare expenditures, thus indicating that timely intervention can ameliorate the management of CKD patients affected by sHPT