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Parravano M.,Fondazione G. B. Bietti Istituto Ricerca e Cura a Carattere Scientifico | Oddone F.,Fondazione G. B. Bietti Istituto Ricerca e Cura a Carattere Scientifico | Boccassini B.,Fondazione G. B. Bietti Istituto Ricerca e Cura a Carattere Scientifico | Menchini F.,University of Udine | And 3 more authors.
Investigative Ophthalmology and Visual Science | Year: 2010

PURPOSE. To assess the test-retest variability of central and sectorial macular thickness measurements obtained by Cirrus HD-OCT (Carl Zeiss Meditec, Dublin, CA) in neovascular agerelated macular degeneration (nAMD). METHODS. Macular thickness measurements of nine standard ETDRS subfields were obtained and analyzed. The repeatability of macular thickness measurements by Cirrus HD-OCT was assessed by examining the intrasession within subject standard deviation (Sw), coefficient of repeatability (CR), and coefficient of variation (CV), before and after eyes with retinal segmentation errors were excluded. RESULTS. Forty-nine nAMD eyes of 49 consecutive patients were included in the study. The CR for the central macular subfield was 42.4 μm (10.5%) and ranged from 12.1 μm (3.7%) for the outer nasal to 41.8 μm (11.4%) for the inner nasal subfields. In a secondary analysis, eyes affected by erroneous detection of inner and outer retinal boundaries (6/49, 12.24%) were excluded. The revised coefficient of repeatability for the central macular subfield was 26.1 μm (8.1%) and ranged from 10.3 μm (3.8%) for the outer superior to 30.2 μm (8.3%) for the inner nasal subfields. CONCLUSIONS. Overall, the test-retest variability of Cirrus HDOCT is good for the central and sectorial macular subfields, with a low incidence of scan artifacts. © Association for Research in Vision and Ophthalmology. Source

La Mantia L.,Unit of Neurorehabilitation Multiple Sclerosis Center | Tramacere I.,Neuroepidemiology Unit | Firwana B.,University of Arkansas for Medical Sciences | Pacchetti I.,Neuroepidemiology Unit | And 2 more authors.
Cochrane Database of Systematic Reviews | Year: 2016

Background: Fingolimod was approved in 2010 for the treatment of patients with the relapsing-remitting (RR) form of multiple sclerosis (MS). It was designed to reduce the frequency of exacerbations and to delay disability worsening. Issues on its safety and efficacy, mainly as compared to other disease modifying drugs (DMDs), have been raised. Objectives: To assess the safety and benefit of fingolimod versus placebo, or other disease-modifying drugs (DMDs), in reducing disease activity in people with relapsing-remitting multiple sclerosis (RRMS). Search methods: We searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System (CNS) Group's Specialised Trials Register and US Food and Drug Administration reports (15 February 2016). Selection criteria: Randomised controlled trials (RCTs) assessing the beneficial and harmful effects of fingolimod versus placebo or other approved DMDs in people with RRMS. Data collection and analysis: We used standard methodological procedures as expected by Cochrane. Main results: Six RCTs met our selection criteria. The overall population included 5152 participants; 1621 controls and 3531 treated with fingolimod at different doses; 2061 with 0.5 mg, 1376 with 1.25 mg, and 94 with 5.0 mg daily. Among the controls, 923 participants were treated with placebo and 698 with others DMDs. The treatment duration was six months in three, 12 months in one, and 24 months in two trials. One study was at high risk of bias for blinding, three studies were at high risk of bias for incomplete outcome reporting, and four studies were at high risk of bias for other reasons (co-authors were affiliated with the pharmaceutical company). We retrieved 10 ongoing trials; four of them have been completed. Comparing fingolimod administered at the approved dose of 0.5 mg to placebo, we found that the drug at 24 months increased the probability of being relapse-free (risk ratio (RR) 1.44, 95% confidence interval (CI) (1.28 to 1.63); moderate quality of evidence), but it might lead to little or no difference in preventing disability progression (RR 1.07, 95% CI 1.02 to 1.11; primary clinical endpoints; low quality evidence). Benefit was observed for other measures of inflammatory disease activity including clinical (annualised relapse rate): rate ratio 0.50, 95% CI 0.40 to 0.62; moderate quality evidence; and magnetic resonance imaging (MRI) activity (gadolinium-enhancing lesions): RR of being free from (MRI) gadolinium-enhancing lesions: 1.36, 95% CI 1.27 to 1.45; low quality evidence. The mean change of MRI T2-weighted lesion load favoured fingolimod at 12 and 24 months. No significant increased risk of discontinuation due to adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months. The risk of fingolimod discontinuation was significantly higher compared to placebo for the dose 1.25 mg at 24 months (RR 1.93, 95% CI 1.48 to 2.52). No significant increased risk of discontinuation due to serious adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months. A significant increased risk of discontinuation due to serious adverse events was found for fingolimod 5.0 mg (RR 2.77, 95% CI 1.04 to 7.38) compared to placebo at six months. Comparing fingolimod 0.5 mg to intramuscular interferon beta-1a, we found moderate quality evidence that the drug at one year slightly increased the number of participants free from relapse (RR 1.18, 95% CI 1.09 to 1.27) or from gadolinium-enhancing lesions (RR 1.12, 95% CI 1.05 to 1.19), and decreased the relapse rate (rate ratio 0.48, 95% CI 0.34 to 0.70). We did not detect any advantage for preventing disability progression (RR 1.02, 95% CI 0.99 to 1.06; low quality evidence). We did not detect any significant difference for MRI T2-weighted lesion load change. We found a greater likelihood of participants discontinuing fingolimod, as compared to other DMDs, due to adverse events in the short-term (six months) (RR 3.21, 95% CI 1.16 to 8.86), but there was no significant difference versus interferon beta-1a at 12 months (RR 1.51, 95% CI 0.81 to 2.80; moderate quality evidence). A higher incidence of adverse events was suggestive of the lower tolerability rate of fingolimod compared to interferon-beta 1a. Quality of life was improved in participants after switching from a different DMD to fingolimod at six months, but this effect was not found compared to placebo at 24 months. All studies were sponsored by Novartis Pharma. Authors' conclusions: Treatment with fingolimod compared to placebo in RRMS patients is effective in reducing inflammatory disease activity, but it may lead to little or no difference in preventing disability worsening. The risk of withdrawals due to adverse events requires careful monitoring of patients over time. The evidence on the risk/benefit profile of fingolimod compared with intramuscular interferon beta-1a was uncertain, based on a low number of head-to-head RCTs with short follow-up duration. The ongoing trial results will possibly satisfy these issues. © 2016 The Cochrane Collaboration. Source

Lombardo M.,Fondazione G.B. Bietti IRCCS | Scarinci F.,Fondazione G.B. Bietti IRCCS | Giannini D.,Fondazione G.B. Bietti IRCCS | Giannini D.,University of Rome La Sapienza | And 6 more authors.
Retina | Year: 2016

Purpose: To investigate the changes of the vitreomacular interface during a 1-year follow-up after idiopathic epiretinal membrane (iERM) surgery. Methods: Six patients affected by fovea-attached iERM were recruited in this pilot study. Pars plana vitrectomy associated with epiretinal membrane peeling was performed uneventfully in all cases. In four cases, the inner limiting membrane was removed using Brilliant blue G. En face high-resolution adaptive optics and cross-sectional spectral domain optical coherence tomography retinal imaging were performed before and at 1, 3, 6, and 12 months after surgery. The microstructures of vitreomacular interface in highresolution adaptive optics images were correlated to the cross-sectional spectral domain optical coherence tomography data. Results: Preoperatively, adaptive optics images showed multiple abnormalities of the vitreomacular interface, such as macrofolds, microfolds, and hyperreflective microstructures. We identified two subtypes of iERM according to the distribution of microfolds over the foveal area, which included the radial-type and the grid-type iERM. After surgery, the morphology of the vitreomacular interface changed compared with the preoperative state. The number of both macrofolds and microfolds was reduced in all cases. The hyperreflective structures were still resolvable in all cases, however presenting different shape and morphology than preoperatively. In addition, they showed marked differences between eyes that had internal limiting membrane removal and eyes that did not. Conclusion: Adaptive optics imaging gives new insight into the changes of vitreomacular interface after iERM surgery. Enhanced multimodal imaging of the vitreomacular interface and retinal structures can be valuable to monitor treatment outcome of iERM. Source

Serrao S.,Fondazione G.B. Bietti IRCCS | Lombardo G.,CNR Institute for Chemical and Physical Processes | Lombardo G.,Vision Engineering Italy srl | Desiderio G.,CNR Institute for Chemical and Physical Processes | And 4 more authors.
Journal of Ophthalmology | Year: 2014

Purpose. To investigate the structure and irregularity of the capsulotomy cutting edges created by two femtosecond (FS) laser platforms in comparison with manual continuous circular capsulorhexis (CCC) using environmental scanning electron microscopy (eSEM). Methods. Ten anterior capsulotomies were obtained using two different FS laser cataract platforms (LenSx, n=5, and Victus, n=5). In addition, five manual CCC (n=5) were obtained using a rhexis forceps. The specimens were imaged by eSEM (FEI Quanta 400, OR, USA). Objective metrics, which included the arithmetic mean deviation of the surface (Sa) and the root-mean-square deviation of the surface (Sq), were used to evaluate the irregularity of both the FS laser capsulotomies and the manual CCC cutting edges. Results. Several microirregularities were shown across the FS laser capsulotomy cutting edges. The edges of manually torn capsules were shown, by comparison of Sa and Sq values, to be smoother (P<0.05) than the FS laser capsulotomy edges. Conclusions. Work is needed to understand whether the FS laser capsulotomy edge microirregularities, not seen in manual CCC, may act as focal points for the concentration of stress that would increase the risk of capsular tear during phacoemulsification as recently reported in the literature. © 2014 Sebastiano Serrao et al. Source

Galeoto G.,University of Rome La Sapienza | Mollica R.,University of Rome La Sapienza | Astorino O.,Azienda Ospedaliera San Giovanni Addolorata | Cecchi R.,University of Rome La Sapienza
Giornale Italiano di Medicina del Lavoro ed Ergonomia | Year: 2015

The aim of the work is to highlight the need, the duty and the obligation also for the physiotherapist to obtain a valid informed consent of the patient. Materials and methods: The authors, starting with the informed consent forms that already exist for physicians, offer four modules tailored to the needs of the physiotherapist, specific to each field of rehabilitation. Results and conclusions: Such informed consent may be very useful to physiotherapists to fulfill the obligations of giving information and obtaining consent from patients. At the same time it allows physiotherapists to obtain all information they need about patient's condition and permit patient to understand the proposed treatment and adhere to it. © PI-ME, Pavia 2015. Source

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