Procto-Glyvenol© accelerates the natural healing process of wounds: a pre-clinical study.

OBJECTIVE: Hemorrhoids are a common anorectal disease that causes pain, itching, and burning. The prevalence of hemorrhoids is estimated to be as high as 36% in the general population, with approximately 50% of individuals experiencing symptomatic hemorrhoids at least once in their life. Middle age, obesity, and pregnancy are risk factors. The combination of tribenoside and lidocaine (Procto-Glyvenol©, Recordati) has been used for decades to treat low-grade hemorrhoids, and its efficacy and safety are well supported by clinical experience. Tribenoside has been shown to have an anti-inflammatory effect, ameliorate the local microcirculation and vascular tone, and promote the healing of basement membrane. However, the molecular mechanism behind its wound-healing properties is still unclear. MATERIALS AND METHODS: Human dermal fibroblasts were used to test the effect of tribenoside on cell proliferation, cell migration, and production of reactive oxygen species in vitro. Full-thickness excisional wound model in rats was used to test the wound-healing properties of Procto-Glyvenol© in vivo. RESULTS: Tribenoside has been found to increase the migration rate of fibroblasts in vitro and to improve the wound healing process by promoting re-epithelialization in rats. Furthermore, novel antioxidant activity of tribenoside has been reported, which may represent a further mechanism of action in wound healing. CONCLUSIONS: Procto-Glyvenol© improves the natural healing process of wounds by stimulating cell migration and protecting against the toxic effects of reactive oxygen species. Therefore, it may represent a first-line treatment for hemorrhoids, which are a significant medical and socioeconomic problem that can deteriorate the quality of life.

Liquid chromatography-tandem mass spectrometry for the simultaneous quantitation of enmetazobactam and cefepime in human plasma.

A simple ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the simultaneous analysis enmetazobactam (also known as AAI101) and cefepime in human plasma. Sample preparation was based on protein precipitation with acetonitrile. Separation was performed on Acquity BEH HILIC column (50 mm × 2.1 mm, 1.7 µm) with a mobile phase containing ammonium formate in water and acetonitrile. The analytes were analyzed with the corresponding isotopically labeled internal standards and were detected in multiple reactions monitoring (MRM) using API 5000 triple-quadrupole mass spectrometer with electrospray (ESI) source operating in positive ion mode. The calibration curves were linear over the selected ranges (r > 0.9970 for both analytes). The intra and inter-assay precision of the Quality Control samples showed CV ≤ 15% and the accuracy was within 85 and 115% in all cases for both compounds. The lower limit of quantification was 0.05 µg/mL for enmetazobactam and 0.5 µg/mL for cefepime.

Feasibility of a psychoeducational family intervention for people with bipolar I disorder and their relatives: Results from an Italian real-world multicentre study.

BACKGROUND: Despite several guidelines recommend the use of psychoeducational family interventions (PFIs) as add-on in the treatment of patients with bipolar I disorder, their implementation on a large scale remains limited. The aim of the present study is to identify obstacles for the feasibility of PFIs in routine care. METHODS: This was a multicentre, real-world, controlled, outpatient trial, carried out in 11 randomly recruited Italian mental health centres. Two mental health professionals from each center attended a modular training course on PFI and provided the intervention. Difficulties and benefits experienced by mental health professionals in implementing the intervention were assessed through the Family Intervention Schedule (FIS-R), which was administered six times. RESULTS: Sixteen out of the 22 recruited professionals completed the training and administered the PFI to 70 patients with bipolar I disorder and their relatives. The retention rate of families receiving the intervention was 93%. Mental health professionals reported high levels of organizational difficulties, several benefits in their daily clinical work and low levels of intervention-related difficulties. The most important organizational obstacles were related to the need to integrate the intervention with other work responsibilities and to the lack of time to carry out the intervention. These difficulties did not decrease over time. Intervention-related difficulties were rated as less problematic since the first time assessment and tended to improve over time. LIMITATIONS: Low number of recruited professionals; use of a not previously validated assessment instrument. CONCLUSIONS: PFIs are feasible in routine care for the treatment of patients with bipolar I disorder and their relatives, and main obstacles are related to the organization/structure of mental health centres, and not to the characteristics of the intervention itself.

Consistency of dosing with a thermal aerosol generation system: in vitro and in vivo correlation.

Dosing consistency and reproducibility are presented for a novel pharmaceutical inhaler technology based on a thermal condensation process. Two different device platforms producing thermally generated aerosols have been created and used in clinical studies with a number of different drug compounds. Because this approach does not rely on energy from the user to disperse the aerosol particles, aerosol production is reliable, reproducible and virtually user independent following actuation. Pharmacokinetic data from multiple clinical studies show rapid absorption, dose proportionality, and concentration levels and variability similar to intravenous injection. In addition, products used in clinical trials show excellent subject consistency with the vast majority of devices delivering greater than 90% of the loaded dose and little drug exhaled.

Current trends in ß-lactam based ß-lactamases inhibitors.

The introduction of antibiotics to treat bacterial infections either by killing or blocking their growth has been accompanied by the development of resistance mechanism that allows the bacteria to survive and proliferate. In particular the successive series of ß-lactams have selected several generations of ß-lactamases including ESBLs, AmpC ß-lactamases, KPC carbapenamases in Enterobacteriaceae, the metallo ß-lactamases VIMs and IMPs, and very recently the threatening NDM-1 that confers resistance to virtually any clinically used antibiotic. The increasing use of carbapenems due to the spread of resistance to other existing antibacterial agents has facilitated the spread of resistance, especially in Acinetobacter spp. due to OXA- and metallo-carbapenemases. The pharmaceutical industry, that abandoned this field at the end of the nineties, is now trying to recover by developing some novel ß-lactam antibiotics and novel ß-lactamase-inhibitors, the latter to be used in combination with new as well as seasoned ß-lactam antibiotics. This article provides a survey of patent and scientific literature for ß-lactamase inhibitors discovered in the period 2006-2010.

Comparison between single-step and balloon dilatational tracheostomy in intensive care unit: a single-centre, randomized controlled study.

BACKGROUND: Balloon dilatational tracheostomy using the Ciaglia Blue Dolphin device has recently been introduced as a modification of the Ciaglia technique. The aim of this study was to compare the new Dolphin system with the single-step dilatational tracheostomy (Ciaglia Blue Rhino) in intensive care unit (ICU) patients. METHODS: Consecutive patients admitted to the ICU of the Emergency Department (Careggi Teaching Hospital, Florence, Italy) from January 2009 to October 2009, aged >18 years and with an indication for percutaneous dilatational tracheostomy (PDT), were enrolled. Exclusion criteria were infection/injury/malignancy of the neck, thyroid gland hypertrophy, severe head injury with uncontrolled intracranial hypertension, and coagulopathy. Patients were randomly assigned to undergo PDT using either the Ciaglia Blue Rhino (n=35) or the Ciaglia Blue Dolphin technique (n=35). Groups were compared according to tracheal puncture, tracheal tube placement time, procedure-related complications, and bleeding. RESULTS: Baseline clinical data were comparable between the two groups. Median procedure time was significantly shorter in the Rhino group compared with the Dolphin group (1.5 vs 4 min, P = 0.035). The presence of limited intra-tracheal bleeding at bronchoscopy examination after 6 h from PDT was more frequent in the Dolphin group than in the Rhino group patients (68.6% vs 34.3%, respectively, P = 0.008). No major bleeding occurred in either group. CONCLUSIONS: PDT using the Ciaglia Blue Dolphin technique is a feasible and viable option in ICU patients, but the Rhino technique had a shorter execution time and seemed to be associated with fewer tracheal injuries.

The value of lung ultrasound monitoring in H1N1 acute respiratory distress syndrome.

We present the case of a healthy young male who developed acute respiratory failure as a result of infection with influenza A/H1N1 of swine-origin and in whom ventilatory support was optimised and recovery of lung function was monitored by the use of sequential chest ultrasound examinations. The potential pivotal role of bedside lung ultrasonography in H1N1-induced respiratory failure is discussed.

Clonal differences in survival capacity, copper and zinc accumulation, and correlation with leaf polyamine levels in poplar: a large-scale field trial on heavily polluted soil.

Three ex situ collections of poplar clones from natural populations of Populus alba and P. nigra growing in northern Italy were assessed for their genetic dissimilarity (GD) by means of amplified fragment length polymorphism (AFLP). The high GD evidenced within populations was exploited for screening 168 clones in a field trial on heavy metal-polluted soil. After one growth season, clonal differences in plant survival and growth were observed. On the basis of performance, six clones were singled out, and used to evaluate copper and zinc accumulation in different organs. Clonal differences in metal concentrations were most evident for leaves and stems; one clone of P. alba (AL35) had a distinctly higher concentration of both metals in the roots. Leaf polyamine (putrescine, spermidine, spermine) profiles correlated with tissue metal concentrations, depending on the clone, plant organ and metal. In particular, the high metal-accumulating clone AL35 exhibited a dramatically higher concentration of free and conjugated putrescine. Overall, the results indicate that, given the high GD of Populus even within populations, it is possible to identify genotypes best suited for soil clean-up, and useful also for investigating physiological markers associated with high metal accumulation/tolerance.

Methyl jasmonate differentially affects tocopherol content and tyrosine amino transferase activity in cultured cells of Amaranthus caudatus and Chenopodium quinoa.

Tocopherols are lipid-soluble compounds synthesised exclusively by photosynthetic organisms. In this study, in vitro callus cultures were established from two plants that are naturally rich in tocopherols, Amaranthus caudatus and Chenopodium quinoa, in order to examine whether callus cultures were able to produce these compounds at levels comparable to those observed in planta. In both species, cotyledon explants produced the best callus induction and, once established, callus cultures were grown under two different hormonal treatments to check for effects of growth and to induce chloroplast differentiation in the cells. A rapid differentiation of chloroplasts occurred only in C. quinoa cell aggregates grown in the presence of benzyladenine, leading to the production of a homogeneous green callus. In both species, only alpha-tocopherol was produced by callus cultures, although levels were much lower than in planta, and the production was not influenced by the hormonal conditions. Interestingly, cell cultures of the two species responded in different ways to methyl jasmonate (MJ). In A. caudatus cultures, treatment with 100 mum MJ increased the production of alpha-tocopherol up to fivefold, and the inductive effect was influenced by the hormonal composition of the medium. This increase in alpha-tocopherol was associated with a proportional increase in tyrosine aminotransferase (TAT) activity, one of the key enzymes involved in tocopherol biosynthesis. By contrast, in C. quinoa cultures, elicitation with MJ did not have any effect, neither on tocopherol production, nor on TAT activity. These results are discussed in relation to chloroplast differentiation and the interplay between jasmonates and phytohormones.

Visual outcome after excimer laser refractive surgery in adult patients with amblyopia.

PURPOSE: To evaluate the visual and refractive outcome in adult patients wi th refractive and anisometropic amblyopia treated with photorefractive keratectomy. METHODS: An interventional non-comparative study was performed on 50 consecutive patients with amblyopia treated with photorefractive keratectomy. Sixty-eight eyes of 18 participants with bilateral refractive amblyopia and 32 participants with unilateral anisometropic amblyopia were studied. The photorefractive keratectomy was performed with MEL 70 G-Scan excimer laser. Follow-up was 1, 3, 6, and 12 months after the treatment. The mean outcome measures were uncorrected visual acuity (UCVA), best spectacle corrected visual acuity (BCVA), refraction, and corneal transparency. RESULTS: In 64.7% of eyes, the UCVA at 12 months after the treatment was better than or equal to their preoperative BCVA. A total of 82.4% of eyes improved their BCVA one or more lines. No eye lost lines of BCVA, 17.6% remained unvaried, 50% gained one line, 20.6 % gained two lines, and 11.8% gained three lines of BCVA. The number of lines gained correlated strongly with diopters of anisometropia between eyes (p<0.01). The mean sphere changed from -5.62+/-3.37 D to -0.47+/-1 D, mean cylinder varied from -2.36+/-1.57 to -0.18+/-0.41 D, and the spherical equivalent varied from -6.82+/-3.1 to -0.45+/-1.08 D. No clinically significant haze was observed. CONCLUSIONS: Excimer laser refractive surgery appears to be a safe and efficient procedure in the treatment of ametropic and anisometropic amblyopia in adults. Adult patients with anisometropic and refractive amblyopia could benefit from the refractive treatment with significant improvement of the visual acuity.

Methyl jasmonate disrupts shoot formation in tobacco thin cell layers by over-inducing mitotic activity and cell expansion.

The aim of the present study was to determine early cyto-histological events associated with the reduced number of shoots formed at the end of culture in tobacco (Nicotiana tabacum L.) thin cell layers treated with methyl jasmonate (MJ) [S. Biondi et al. (2001) J Exp Bot 52:1-12]. The results show that 0.1-10 microM MJ strongly stimulated mitotic activity early in culture relative to untreated controls. Treatment with MJ also induced anomalous mitoses. Enhanced proliferative growth was confirmed by northern analysis and in situ hybridisation using cDNA probes of the G1/S phase-specific genes ubiquitin carboxyl-extension protein (ubi-CEP), topoisomerase 1 (top1) and ribonucleotide reductase (RNR). The formation of meristematic cell clusters on day 5 was also enhanced by 1 muM MJ, but subsequent development of these cell clusters into meristemoids and shoot primordia was reduced by all MJ concentrations in a dose-dependent manner. Cell expansion was stimulated by MJ concentrations ranging from 0.001 to 10 microM; expanded cells frequently occurred around and within meristemoids and shoot primordia, and displayed thickened and suberised cell walls; cell wall thickness increased with increasing MJ concentration. These cytological events caused alterations in the tunica and stem differentiation of the shoot dome. The apparently paradoxical role of MJ, which deregulates shoot formation through a stimulation of growth events, i.e., mitotic activity and cell expansion, is discussed.

Presurgical antimicrobial prophylaxis: effect on ocular flora in healthy patients.

OBJECTIVE: Evaluation of presurgical antimicrobial prophylaxis for reduction of ocular flora. SETTING: Ophthalmology Section, Department of Medicine and Surgery, University of Catania, Italy. METHODS: Three days before photorefractive keratectomy (PRK), conjunctiva of 70 healthy patients (100 eyes) were swabbed. After 3 days of instillation of ofloxacin 0.3% (3 times daily), conjunctival swabs were taken again. Bacteria were isolated and identified from each swab. RESULTS: A total of 191 independent isolates were obtained prior to antimicrobial treatment. Bacteria were isolated from all 100 eyes sampled. Gram-positive species predominated, with Staphylococcus epidermidis and Staphylococcus aureus cultured from 69% and 25% of eyes sampled, respectively. Species of the anaerobic genera Peptococcus and Peptostreptococcus were found in 22% and 14% of eyes, respectively. After prophylaxis with ofloxacin, bacteria could be cultured from only 7% of eyes (10 independent isolates). All isolates were sensitive to ofloxacin except 5 strains of S. epidermidis, which displayed intermediate sensitivity. No infections occurred after PRK. CONCLUSION: Prophylaxis by instillation of ofloxacin 0.3% 3 times daily for 3 days substantially reduced the ocular flora of 100 healthy eyes prior to refractive surgery.

Prevalence of oesophagitis in patients with persistent upper respiratory symptoms.

A growing body of evidence suggests that a variety of upper respiratory symptoms (URS) are associated with gastro-oesophageal reflux (GORD). The aim of this study was to determine the prevalence of endoscopic erosive, and non-erosive, oesophagitis among patients complaining of persistent URS, in the absence of typical GORD symptoms, and to compare them with a comparison group of similar age. A group of 110 patients aged 18-75, presenting with persistent URS with no suspicion of GORD symptoms, underwent upper flexible endoscopy, with biopsy sampling for histology, and was compared with a group of 117 patients of similar age undergoing endoscopy for reasons other than GORD. Patients affected with upper airway disorders, such as posterior laryngitis, chronic sinusitis and vocal fold nodules, had a significantly higher prevalence of oesophagitis of varying degrees (31 per cent) compared to the comparison population (15.4 per cent) (p < 0.01). These data suggest that in many patients with chronic URS occult gastro-oesophageal diseases are present.

Transglutaminase activity during senescence and programmed cell death in the corolla of tobacco (Nicotiana tabacum) flowers.

Corolla life span of undetached flowers of Nicotiana tabacum was divided into stages from the closed corolla (stage 1) through anthesis (stage 5) to death (stage 9). Senescence began around stage 6 in the proximal part, concomitantly with DNA laddering. Nuclear blebbing, DNA laddering, cell wall modification, decline in protein, water, pigment content and membrane integrity were observed during senescence and PCD. Transglutaminase activity was measured as mono- and bis-derivatives of putrescine (mono-PU; bis-PU) and bis-derivatives of spermidine (bis-SD). Bis-derivatives decreased with the progression of senescence, while mono-PU increased during early senescence; derivatives were present in different amounts in the proximal and distal parts of the corolla. In excised flowers, exogenous spermine delayed senescence and PCD, and caused an increase in free and acid-soluble conjugated PA levels. Bis-PU was the most abundant PA-derivative before DNA laddering stage; thereafter, bis-PU generally decreased and mono-PU became the most abundant derivative.

Methyl jasmonate upregulates biosynthetic gene expression, oxidation and conjugation of polyamines, and inhibits shoot formation in tobacco thin layers.

The effect of methyl jasmonate (MJ) on de novo shoot formation and polyamine metabolism was investigated in thin layer explants of tobacco (Nicotiana tabacum L. cv. Samsun). A relatively low concentration of MJ (0.1 microM) enhanced explant fresh weight, but had no effect on the final number of shoots per explant while higher concentrations (1 and 10 microM) significantly inhibited organogenesis. The histological study revealed that, with increasing concentrations of MJ, the formation of meristemoids and shoot domes declined and the incidence of cell hypertrophy increased. In explants cultured with 0.1, 1 or 10 microM MJ, the endogenous levels of free putrescine, spermidine and spermine generally declined compared with controls, after 7 and 15 d. Perchloric acid-soluble conjugated polyamines accumulated dramatically during culture, but much more so in the presence of MJ than in controls. Acid-insoluble conjugated spermidine alone increased in response to the elicitor. Activities of the putrescine biosynthetic enzymes arginine decarboxylase (ADC, EC 4.1.1.19) and ornithine decarboxylase (ODC, EC 4.1.1.17) in the soluble fraction of MJ-treated explants displayed up to 3-fold increases relative to control explants. However, the most relevant increases in these enzyme activities occurred in the particulate fraction. The activity of S:-adenosylmethionine decarboxylase (SAMDC, EC 4.1.1.21), an enzyme involved in spermidine and spermine biosynthesis, was also stimulated by exposure to MJ. Northern analyses revealed MJ-induced, generally dose-dependent, increases in the mRNA levels of all three enzymes. Diamine oxidase (DAO, EC 1.4.3.6) activity was stimulated by MJ mainly in the cell wall fraction. The upregulation of polyamine metabolism is discussed in relation to the morphogenic behaviour of MJ-treated explants.

Laryngeal cytological aspects in women with surgically induced menopause who were treated with transdermal estrogen replacement therapy.

OBJECTIVE: To investigate the effects of estrogen replacement therapy (ERT) on laryngeal cytology in postmenopausal women. DESIGN: Prospective open clinical trial. SETTING: Outpatient menopausal clinic in the Department of Gynecology, University of Catania, Catania, Italy. PATIENT(S): Eighty-four healthy, surgically postmenopausal women, of whom 48 were treated with ERT and 36 were considered as a control group. INTERVENTION(S): Transdermal E(2) treatment by patches or gel, evaluation of laryngeal cytology with cytobrush by indirect laryngoscopy, and questionnaire for the voice history. MAIN OUTCOME MEASURE(S): Changes in cytologic aspects of laryngeal cells with respect to vaginal cytology by hematoxylin and eosin staining; subjective voice changes. RESULT(S): Sixty-seven women completed the study. Ten women from the ERT group and five from the control group dropped out because of the invasive laryngoscope method; two subjects in the control group were excluded because of pathologies of the vocal cord. Hematoxylin and eosin staining confirmed similar superficial-intermediate aspects of the cells between the laryngeal and the vaginal smears in ERT-treated women. In the control group, both smears showed aspects of atrophy-dystrophy. The ERT group had a subjectively better quality of voice than the control group. CONCLUSION(S): Our study confirms that the larynx is an estrogen target, as are vaginal cells. ERT may provide prevention and treatment of dystrophic pathologies of the vocal cords in postmenopausal women.

Jasmonates induce over-accumulation of methylputrescine and conjugated polyamines in Hyoscyamus muticus L. root cultures.

Jasmonic acid (JA) and its methyl ester (MeJA) at concentrations ranging from 0.001 to 10 µM provoked large increases in methylputrescine levels in normal and hairy roots of Hyoscyamus muticus L.; generally, levels of free putrescine and perchloric acid-soluble conjugated putrescine, spermidine and spermine also increased dramatically. More 14C-putrescine was formed when hairy roots were incubated with labelled ornithine than with arginine; conjugated 14C-putrescine was also rapidly formed. In accord with these results, ornithine decarboxylase (EC 4.1.1.17) activity was higher than that of arginine decarboxylase (EC 4.1.1.19), and MeJA enhanced these activities about two- and fourfold, respectively. Although treatment of root cultures with jasmonates enhanced precursor (putrescine, methylputrescine) levels and accumulation of secondary metabolites such as acid-soluble conjugated di-/polyamines, it provoked only modest increases in tropane alkaloid tissue levels.

[An unusual case of orbital cellulitis and perforating scleromalacia]. / Cas insolite de cellulite orbitaire et scléromalacie perforante.

We report the case of a diabetic patient with refractory anemia with excess blasts (RAEB) who developed bladder infection followed by orbital cellulitis and nodular skin lesions. After a short remission, the clinical aspect was complicated by corneal ulceration, scleromalacia, bulbar perforation and lens luxation.

Indications and results of fronto-lateral laryngectomy using a combined endolaryngeal and external approach.

Patients with laryngeal anterior commissure, cord-commissure, bilateral anterior cord-commissure carcinomas (T1 and T2 N0 M0) were subjected to a new method of frontolateral laryngectomy using a combined endolaryngeal and external approach. The proposed surgical procedure allowed the removal of the anterior commissure and part of one or both vocal cords in a single unit, together with the cartilaginous framework, respecting the integrity of the superior portion of the thyroid cartilage. The internal procedure permitted an accurate delimitation of the posterior part of the laryngeal neoplasm. In particular, this was performed during suspension microlaryngoscopy using the CO(2) laser or traditional cutting tools for section of the laryngeal visceral structures to the internal surface of the thyroid cartilage. Following this, the external approach included incision of the external perichondrium along the superior edge of the thyroid cartilage and along the median line, from the incisura to the inferior edge of the thyroid cartilage. The superior opening of the larynx is made side-to-side and the epiglottis separated at the level of the superior edge of the thyroid cartilage. The ends of the section are joined together with the superior parts of the section created during the laryngeal approach. Then progressive craniocaudal detachment of the internal perichondrium is performed backwards until the endolaryngeal sections are reached and downwards to the insertion of the cord ligaments. The inferior opening of the larynx is made by a horizontal section of the cricothyroid membrane at the level of the superior edge of the cricoid cartilage. Section of the thyroid cartilage is therefore performed in a trapezoidal shape. This section involves the inferior part of the protruding corner of the thyroid cartilage. After joining the ends of the cricothyroid section with the inferior extremities of the endolaryngeal sections, the surgical specimen is removed as a single unit. The method must be used only after accurate clinical evaluation. It is mostly recommended in subjects with cord-commissure carcinomas previously treated with radiotherapy. The results obtained were extremely satisfactory both as regards survival and functional results. In all, 27/28 patients (96.4%) were free from disease. The quality of voice was satisfactory but hoarse in 30% and breathy in 70% of the patients.

Long-term visual results of bifocal intraocular lens implantation.

PURPOSE: To evaluate the long-term visual results and variability in contrast sensitivity in patients with heparin-surface-modified (HSM) diffractive bifocal intraocular lenses (IOLs). SETTING: Institute of Ophthalmology, University of Catania, Italy. METHODS: In this prospective study, visual acuity (distance and near) and contrast sensitivity were measured in 35 patients who had phacoemulsification with bifocal diffractive IOL (model 811E, Pharmacia) implantation. Patient satisfaction was also evaluated using a questionnaire. Mean follow-up was 20 months (range 18 to 24 months). RESULTS: At the last examination, mean distance visual acuity was 0.79 +/- 0.2 (SD) without correction and 1.0 +/- 0.15 with best correction. Mean uncorrected near visual acuity was J1.6 +/- J0.77 and with best distance correction, J1.19 +/- J0.49. No statistically significant changes in visual acuity were evident at the last follow-up (Student t test). No changes were found in contrast sensitivity reduction over time, nor were late postoperative complications noted. Overall patient satisfaction was rated as good by 94.3% of patients with best distance correction. CONCLUSIONS: The diffractive bifocal HSM IOL provided good visual performance for distance and near over time. In relation to the low rate of postoperative complications, the slight contrast sensitivity reduction was stable during follow-up.