Burden of Infantile Hemangioma on Family: An International Observational Cross-Sectional Study.

BACKGROUND/OBJECTIVES: Infantile hemangioma (IH) is the most frequent benign tumor of infancy resulting from vascular proliferation. Data regarding the burden on families of children with IHs are limited. This study aimed to characterize IHs and provide a comprehensive evaluation of the burden of IHs on parents of children requiring systemic treatment in the United States and Europe. METHODS: This noninterventional cross-sectional study included infants with newly diagnosed IH requiring systemic treatment. A parent or family member completed two questionnaires (Family Member questionnaire; Hemangioma Family Burden [HFB] questionnaire). RESULTS: A total of 693 individuals were evaluable in five countries. IHs were observed in more girls than boys (66%-83% female) and the mean age at inclusion was 0.44 to 1.4 years. Approximately half of patients had superficial IHs, approximately 70% of cases affected the head, and approximately 80% of cases were moderate or severe. Most patients received propranolol treatment. Their child's IH affected more than 70% of parents in each country, but fewer than 10% were offered psychological support. Approximately half of all parents reported that their child's IH affected their professional life. The global HFB score was significantly (p < 0.001) greater with greater IH severity. More than 90% of parents in each country were satisfied with the care of their child's disease. CONCLUSIONS: This international study using the validated HFB questionnaire provides further insight into the burden of IH and highlights potential areas for future focus in assisting families with affected children.

Burden of advanced breast cancer for patients and caregivers in Europe: comparison of two treatment forms of vinorelbine, oral and intravenous.

AIM: To assess the burden of disease associated with advanced breast cancer (ABC) treated with oral (VinO) or intravenous vinorelbine (VinIV) from the perspective of patients and caregivers in five European countries. METHODS: This was an observational, prospective, international, multicenter study. Patients were included in the study at the beginning of their second cycle of chemotherapy with vinorelbine and categorized into two groups depending on whether they received VinO or VinIV. At baseline (V0) and at the end of the second cycle of chemotherapy (V1), patients and caregivers were asked to complete self-administered questionnaires: SF-12 and burden of disease. RESULTS: At baseline, the two groups were well balanced in demographic and clinical characteristics. However, while HER2+ (human epidermal growth factor receptor 2) disease was significantly more frequent in patients receiving VinIV, patients receiving VinO were predominantly treated with single-agent therapy and were older than those treated with VinIV (67.1 years versus 57.7 years [p = 0.05]). As measured with SF-12, patients with VinO had, at end of cycle 1 and end of cycle 2, significantly more favorable outcomes in physical summary score, role physical, role emotional and mental health (all p < 0.05) than those treated with VinIV. Trends for a better caregiver mental score and social functioning were also observed with VinO (cycle 1 and 2; p < 0.10). From a patient perspective, no major difference was reported on the burden of disease between the two groups, however, a trend for a better" overall impact on daily life" was observed in VinO patients. Major significant differences, showing a lower burden of disease with VinO, were also reported from caregivers. In addition, in patients treated with VinO, mental score was almost similar to the one of the general population. CONCLUSION: VinO showed benefits over VinIV for both patients and caregivers, particularly in health related quality of life and burden of disease. Because of its observational design, results are only informative.

Public health and budget impact of probiotics on common respiratory tract infections: a modelling study.

OBJECTIVES: Two recent meta-analyses by the York Health Economics Consortium (YHEC) and Cochrane demonstrated probiotic efficacy in reducing the duration and number of common respiratory tract infections (CRTI) and associated antibiotic prescriptions. A health-economic analysis was undertaken to estimate the public health and budget consequences of a generalized probiotic consumption in France. METHODS: A virtual age- and gender-standardized population was generated using a Markov microsimulation model. CRTI risk factors incorporated into this model were age, active/passive smoking and living in a community setting. Incidence rates and resource utilization were based on the 2011-2012 flu season and retrieved from the French GPs Sentinelles network. Results of both meta-analyses were independently applied to the French population to estimate CRTI events, assuming a generalized probiotic use compared to no probiotics during winter months: -0.77 days/CRTI episode (YHEC scenario) or odds-ratio 0.58 for ≥1 CRTI episode (Cochrane scenario) with vs. without probiotics. Economic perspectives were National Health System (NHS), society, family. Outcomes included cost savings related to the reduced numbers of CRTI episodes, days of illness, number of antibiotic courses, sick leave days, medical and indirect costs. RESULTS: For France, generalized probiotic use would save 2.4 million CRTI-days, 291,000 antibiotic courses and 581,000 sick leave days, based on YHEC data. Applying the Cochrane data, reductions were 6.6 million CRTI days, 473,000 antibiotic courses and 1.5 million sick days. From the NHS perspective, probiotics' economic impact was about €14.6 million saved according to YHEC and €37.7 million according to Cochrane. Higher savings were observed in children, active smokers and people with more frequent human contacts. CONCLUSIONS: Public health and budget impact of probiotics are substantial, whether they reduce CRTI episodes frequency or duration. Noteworthy, the 2011-12 winter CRTI incidence was low and this analysis focused on the fraction of CRTI patients consulting a practitioner.

Cost utility of telaprevir-PR (peginterferon-ribavirin) versus boceprevir-PR and versus PR alone in chronic hepatitis C in The Netherlands.

BACKGROUND: The hepatitis C virus may lead to cirrhosis, liver cancer, liver transplant, and increased mortality. With standard treatment peginterferon-alpha and ribavirin (PR), sustained viral response (SVR) was less than 50 %. SVR rates improve greatly when PR is combined with telaprevir or boceprevir. OBJECTIVES: The aim of this study was to assess the cost utility of telaprevir-peginterferon-ribavirin (TPR) versus PR and boceprevir-peginterferon-ribavirin (BPR) in treatment-naïve (TN) and treatment-experienced (TE) adults with chronic hepatitis C in the Netherlands. METHODS: A Markov model with a lifelong time horizon and annual cycles was developed. Clinical data stemmed from phase III trials (TPR vs PR, BPR vs PR). A mixed treatment comparison (MTC) was developed to compare TPR and BPR indirectly. Unit costs and utilities based on EQ-5D were established in a Dutch cross-sectional study. Cost per quality-adjusted life-years (QALYs) was calculated according to the societal perspective. RESULTS: Treating TN patients with TPR generates 1.12 additional QALYs with €333 additional cost compared with PR, resulting in an incremental cost-utility ratio of €299/QALY. In TE patients, TPR dominates PR with cost savings (-€7,819) and 1.63 additional QALYs. TPR dominates BPR yielding additional QALYs (0.26 in TN; 0.71 in TE) and cost savings (-€7,296, -€18,144, respectively). CONCLUSIONS: TPR seems a cost-effective alternative to PR in TN patients and dominant in TE patients. TPR was a dominant, more effective and less costly alternative to BPR in both patient types. The cost effectiveness of both TPR and BPR is well below generally accepted willingness-to-pay thresholds and may be considered cost effective.

Glaucoma costs in Denmark in treatment naive patients.

PURPOSE: To describe the costs and providers of glaucoma treatment in Denmark. METHODS: Analyses were based on National Register data. Glaucoma/OHT patients were identified by their first prescription for glaucoma medication (ATC-codes) in the Danish Register of Medicinal Product Statistics 2002-2007. Patients had used no glaucoma medication for 6 months. Data for 2007 were sampled cross-sectionally for a budgetary analysis of glaucoma (ICD10 code) medication and services consumed in the primary and secondary health care services. Patients were categorized according to their number of treatment changes. RESULTS: The Danish annual incidence rate of glaucoma was estimated at 1.2 per 1000 adult persons. Thirty-seven per cent of patients (men 44%, mean age 68 years; women 56%, mean age 71 years) persisted with their initial treatment regimen, 21% had changed to a second regimen, and 43% had experienced ≥ 3 regimens. Treatment costs increased with the number of sequential regimens. Annual glaucoma costs (health care sector perspective) were €305 for patients under their initial regimen, increasing to €740 with ≥ 3 regimens. Drug costs accounted for 57% of total cost. CONCLUSIONS: Drugs represented the major cost of glaucoma, and those costs increased, obviously, with the number of treatment changes.

Contribution of modeling approaches and virtual populations in transposing the results of clinical trials into real life and in enlightening public health decisions.

Modeling consists in aggregating separate pieces of knowledge, according to a given structure and rules. It allows studying the behavior of more or less complex systems by simulation techniques. Modeling is used in different state-of-the-art technological domains (meteorology, aeronautics). Its use has grown for the evaluation of medicines and medical devices, from conception to prescription (marketing authorization, reimbursement, price setting and re-registrations). It follows a scientific approach and is the object of good practice recommendations. Coupling models to virtual populations allows obtaining realistic results at the population level, testing diagnostic or therapeutic strategies, as well as estimating the consequences of transposing the results of clinical trials to the population. Through examples, the participants of the Round Table analyzed the contributions of the coupling of models and realistic virtual populations, and proposed guidelines for their judicious and systematic use.

Protoporphyrin retention in hepatocytes and Kupffer cells prevents sclerosing cholangitis in erythropoietic protoporphyria mouse model.

BACKGROUND & AIMS: Chronic, progressive hepatobiliary disease is the most severe complication of erythropoietic protoporphyria (EPP) and can require liver transplantation, although the mechanisms that lead to liver failure are unknown. We characterized protoporphyrin-IX (PPIX)-linked hepatobiliary disease in BALB/c and C57BL/6 (Fechm1Pas) mice with mutations in ferrochelatase as models for EPP. METHODS: Fechm1Pas and wild-type (control) mice were studied at 12-14 weeks of age. PPIX was quantified; its distribution in the liver, serum levels of lipoprotein-X, liver histology, contents of bile salt and cholesterol phospholipids, and expression of genes were compared in mice of the BALB/c and C57BL/6 backgrounds. The in vitro binding affinity of PPIX for bile components was determined. RESULTS: Compared with mice of the C57BL/6 background, BALB/c Fechm1Pas mice had a more severe pattern of cholestasis, fibrosis with portoportal bridging, bile acid regurgitation, sclerosing cholangitis, and hepatolithiasis. In C57BL/6 Fechm1Pas mice, PPIX was sequestrated mainly in the cytosol of hepatocytes and Kupffer cells, whereas, in BALB/c Fechm1Pas mice, PPIX was localized within enlarged bile canaliculi. Livers of C57BL/6 Fechm1Pas mice were protected through a combination of lower efflux of PPIX and reduced synthesis and export of bile acid. CONCLUSIONS: PPIX binds to bile components and disrupts the physiologic equilibrium of phospholipids, bile acids, and cholesterol in bile. This process might be involved in pathogenesis of sclerosing cholangitis from EPP; a better understanding might improve diagnosis and development of reagents to treat or prevent liver failure in patients with EPP.

Efficiency of glaucoma drug regulation in 5 European countries: a 1995-2006 longitudinal prescription analysis.

PURPOSE: To compare the evolution of prostaglandin analog (PGA) and ß-blocker (BB) prescriptions across 5 European countries. METHODS: Data were extracted from various sources: (1) IMS data for France, Germany, Italy, Spain, and the United Kingdom, (2) glaucoma-treated patients from the United Kingdom General Practice Research Database (UK-GPRD), (3) prescriptions delivered by the territorial pharmaceutical service of Monselice of the Padova region (Italy). Drugs were grouped into 3 classes: PGAs, BBs, and other drugs. Yearly market shares were calculated. Treatment persistence survival curves were estimated for Italian and UK data, and the 3 drug groups were compared using the Cochran Mantel Haenszel test. RESULTS: According to Padova data, BBs decreased in market share, whereas PGAs increased. A linear extrapolation of these market shares, based on 1998 to 2003 data, predicted that the 2 curves should cross in 2005, a prediction reinforced by the European Medicines Agency authorization (2002) of PGAs as first-line glaucoma treatments. That this did not occur may be explained by Italy's refusal to reimburse PGAs as first-line therapy. IMS data identified Italy and Germany as 2 countries in which BBs are still more frequently prescribed than PGAs. Treatment persistence with PGAs as monotherapy, in PGA-naive patients, was longer than for BBs according to both Padova and UK-GPRD data. This held true for both first-line and second-line PGA prescriptions (UK-GPRD); the persistence of second-line PGA equalled first-line BB treatment. CONCLUSION: Health care regulations impacted upon glaucoma prescribing and may be one of the reasons for different annual evolution rates of PGA and BB prescriptions.

Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma.

BACKGROUND: This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. METHODS: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication. RESULTS: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation. CONCLUSION: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma.

Treatment persistence and cost-effectiveness of latanoprost/latanoprost-timolol, bimatoprost/bimatoprost-timolol, and travoprost/travoprost-timolol in glaucoma: an analysis based on the United Kingdom general practitioner research database.

OBJECTIVE: To compare treatment persistence and costs with 3 glaucoma treatment sequences (first-line/second-line): latanoprost/latanoprost-timolol (LLT), bimatoprost/bimatoprost-timolol (BBT), and travoprost/travoprost-timolol (TTT), derived from the UK General Practitioner Research Database (UK-GPRD). METHODS: Patient records referring to ocular hypertension, topical glaucoma treatment, surgery, or laser therapy were extracted. Patients prescribed LLT, BBT, or TTT sequences were selected. Treatment failure was inferred from glaucoma prescription change (adding or removing a topical treatment, surgery, or laser therapy). Treatment durations preceding failure were compared by applying Wilcoxon's test to survival curves. Adjustment on confounding variables was performed with a Cox model and a propensity score method. Unit costs were estimated from a UK National Health Service perspective. RESULTS: A total of 1592 patients received LLT, 110 BBT, and 114 TTT. Their mean age was 68 years and the sex ratio almost 1 male:1 female. No significant demographic or comorbidity differences were observed between treatment sequences. Treatment persistence at 36 months was achieved in 60.0% of LLT, 55.5% of BBT, and 70.3% of TTT patients (P = 0.005). Resources consumed and associated monthly costs were significantly less for the TTT group (£17.74) compared with BBT (£21.30) and LLT (£22.37) groups. CONCLUSION: Analysis of data obtained from the UK-GPRD suggests that the TTT treatment sequence achieved longer treatment persistence at lower cost than LLT and BBT.

Comparison of outcomes with multifocal intraocular lenses: a meta-analysis.

PURPOSE: To compare the clinical outcome of different multifocal intraocular lenses (IOLs) based on information reported in the international literature. METHODS: All comparative clinical trials that involved implanting at least one multifocal IOL in patients with cataract or presbyopia were extracted from the literature. Clinical outcomes included uncorrected near visual acuity, uncorrected distance visual acuity, visual acuity, spectacle independence, and halos. Random effects meta-analyses were conducted to compare outcomes for the different IOL types. RESULTS: Twenty papers were identified describing 11 monofocal IOLs and 35 multifocal IOLs (19 diffractive, including 12 ReSTOR(®), 14 refractive, and two accommodative) patient cohorts. Multifocal and monofocal uncorrected distance visual acuity was 0.165 (0.090-0.240) and 0.093 (0.088-0.098), respectively. Compared with monofocal IOLs, multifocal IOLs produced better uncorrected near visual acuity (0.470 [0.322-0.618] versus 0.141 [0.131-0.152]; P < 0.0001), resulting in higher spectacle independence (incidence rate ratio [IRR] 3.62 [2.90-4.52]; P < 0.0001). Compared with refractive multifocal IOLs, diffractive multifocal IOLs produced a similar uncorrected distance visual acuity (0.105 [0.098-0.111] versus 0.085 [0.029-0.140]; P ≤ 0.78, not significant) and better uncorrected near visual acuity (0.217 [0.118-0.317] versus 0.082 [0.067-0.098]; P < 0.0001) resulting in higher spectacle independence (IRR 1.75 [1.24-2.48]; P < 0.001). Compared with other multifocal IOLs, ReSTOR produced a better uncorrected distance visual acuity (0.067 [0.059-0.076] versus 0.093 [0.088-0.098]; P < 0.0001) and better uncorrected near visual acuity (0.064 [0.046-0.082] versus 0.141 [0.131-0.152]; P < 0.006), resulting in higher spectacle independence (IRR 2.06 [1.26-1.36]; P < 0.004). Halo incidence rates with different types of multifocal implants did not differ significantly. CONCLUSION: Multifocal IOLs provide better uncorrected near visual acuity than monofocal IOLs, leading to less need for spectacles. Multifocal IOL design might play a role in postsurgical outcome, because better results were obtained with diffractive lenses. ReSTOR showed better uncorrected near visual acuity, uncorrected distance visual acuity, and higher spectacle independence rates compared with other multifocal IOLs.

Metric properties of the MacDQoL, individualized macular-disease-specific quality of life instrument, and newly identified subscales in French, German, Italian, and American populations.

OBJECTIVES: The aims of this analysis were to confirm the UK results in other countries and to explore the possibility of subscales of the 25-Item Macular disease Dependent Quality of Life (MacDQoL) questionnaire. METHODS: Two clinical studies were pooled. Principal components analyses (Varimax) were conducted on baseline data from each country and from all combined. Factorial structures were compared between countries, and Cronbach alpha values were used to identify item clusters. Four groups of patients were created according to visual acuity (VA) in the best eye (BE < 10/20; BE ≥ 10/20) and worst eye (WE < 10/100; WE ≥ 10/100). These groups were used to investigate (analysis of variance) the sensitivity of MacDQoL to VA impairment and to compare it with the NEI-VFQ-25 generic visual function questionnaire. RESULTS: A total of 797 patients (mean age 76.8 years; 55.8% women) had wet age-related macular degeneration (AMD). Strong correlations between the MacDQoL items (r > 0.48) and factor loadings > 0.49 on a forced one-factor analysis supported the use of an average weighted impact score. Four constructs (Cronbach alpha > 0.8) were derived, represented by the labels: Essential tasks, Family/social life, Activities/capabilities, and Embarrassment. The structure did not differ among the four countries involved, except one item (Finance), which has been excluded. Patients with BE VA <10/20 and WE VA <10/100 produced significantly worse overall scores than those with BE VA >10/20 and WE VA >10/100 (MacDQoL P < 0.0001; NEI-VFQ-25 P < 0.0001). CONCLUSIONS: The analysis confirmed the metric properties of the MacDQoL. The MacDQoL offers a broad individualized measure of the impact of MD on quality of life.

Identification of noncompliant glaucoma patients using Bayesian networks and the Eye-Drop Satisfaction Questionnaire.

OBJECTIVE: To identify poorly compliant glaucoma patients, using the Eye-Drop Satisfaction Questionnaire (EDSQ). METHODS: This was an observational cross-sectional study with compliance data collected by an electronic monitoring device. Patients with primary open-angle glaucoma or ocular hypertension completed the EDSQ, a six-dimension self-reported questionnaire addressing "treatment concern", "disease concern", "patient-clinician relationship", "positive beliefs", "treatment convenience", and "self-declared compliance". A Bayesian network (BN) was applied to explore compliance associations with EDSQ. RESULTS: Among 169 patients who completed the EDSQ, 113 had valid Travalert® data, of whom 25 (22.1%) demonstrated low compliance. All six EDSQ dimensions were associated directly, or indirectly, with compliance. Two profiles exhibited low compliance, ie, patients aged younger than 77.5 years with a poor patient-physician relationship and self-declared poor compliance and patients aged older than 77.5 years with a poor patient-physician relationship and self-declared good compliance. The third profile showed high compliance, ie, patients aged younger than 77.5 years with a good patient-physician relationship and self-declared good compliance. CONCLUSION: Our results confirm a central role for the patient-physician relationship in the compliance process. Age, self-declared compliance, and patient satisfaction with the patient-physician relationship are all dimensions worth exploring before glaucoma medication is switched or proceeding to laser treatment or surgery.

Development of a new subjective questionnaire: the Freedom from Glasses Value Scale (FGVS).

PURPOSE: To develop a patient self-administered questionnaire assessing the added value of complete independence from spectacles (hereafter referred to as glasses) after multifocal intraocular lens (IOL) surgery. METHODS: Exploratory interviews with five cataract patients and six presbyopic patients with AcrySof ReSTOR IOLs (Alcon Laboratories Inc) implanted in both eyes for at least 6 months were conducted. The questionnaire's conceptual framework was developed after interview analysis. Based on the identified concepts, items were generated simultaneously in French and Spanish using patients' own words, and comprehension tested with six French patients; the Spanish questionnaire underwent clinician review and was further tested with four Spanish patients. French and Spanish versions were accordingly refined. The questionnaire was linguistically validated in UK English and Danish. RESULTS: Interview analysis resulted in the identification of 9 global concepts: global vision, practical constraints related to wearing glasses, impact of eye surgery on the patient's life, improvement of practical issues without glasses, improvement of psychological constraints without glasses, physical appearance/aesthetic aspect, self-image and in the eyes of others, eyesight problems left behind after surgery, and recommendation of surgery to others. The initial version of the test questionnaire contained 23 items; 2 items were deleted and changes were made after clinician review and patient testing. The final questionnaire named Freedom from Glasses Value Scale (FGVS) contained 21 items and four general additional questions. CONCLUSIONS: Beyond functional aspects, this qualitative study identified additional benefits in cataract and presbyopic patients living free of glasses after receiving multifocal IOLs. The FGVS now needs to be psychometrically validated (eg, construct validity and reliability).

Measurement of treatment compliance using a medical device for glaucoma patients associated with intraocular pressure control: a survey.

OBJECTIVE: To identify and characterize treatment compliance profiles of glaucoma patients and evaluate the association with intraocular pressure (IOP). METHODS: A computerized device (Travalert((R))) that recorded daily instillation times and eye-drop counts was given for 3 months. Patients were declared compliant when at least 2 drops were instilled per day. Compliance rates were calculated for weekdays and weekends, separately, over 8 consecutive weeks. A principal components analysis (PCA) was followed by an ascendant hierarchical classification (AHC) to identify compliance groups. RESULTS: 140 patients were recruited (mean age 65.5 years; 51.8% female) of whom 83.6% had primary open-angle glaucoma with mean IOP 23.9 mmHg before Travalert((R)) use. 60.7% were treated with DuoTrav((R)) (travoprost timolol fixed combination) and 39.3% with travoprost. The PCA identified two axes (compliance and treatment weeks). The AHC identified 3 compliance groups: 'high' (56.6%, approx. 80% compliance), 'medium' (21.2%, approx. 50% compliance), and 'low' (22.1%, approx. 20% compliance). Demographics and glaucoma parameters did not predict low compliance. Final mean IOP was 16.1 mmHg, but higher in the low compliance group (17.7 mmHg, P = 0.02). CONCLUSIONS: Compliance measurement by a medical device showed compliance rates <80% by 50% (approx.) of patients, significantly impacting IOP control. No demographic or glaucoma variable was associated with low compliance.

Neodymium:YAG laser rates after bilateral implantation of hydrophobic or hydrophilic multifocal intraocular lenses: twenty-four month retrospective comparative study.

PURPOSE: To compare 2-year neodymium:YAG (Nd:YAG) laser capsulotomy rates after bilateral implantation of hydrophobic or hydrophilic multifocal intraocular lenses (IOLs). SETTING: Private practice, southwest France. METHODS: This retrospective study included patients with cataract or clear lenses who had bilateral implantation of AcrySof ReSTOR hydrophobic or Acri.LISA hydrophilic acrylic multifocal IOLs between May 2004 and June 2009 by the same surgeon at 1 clinic. Data were extracted from patients' files maintained by the surgeon and ophthalmologists involved in postoperative care. Time from IOL implantation to Nd:YAG laser capsulotomy was analyzed with Kaplan-Meier survival curves. Imbalances in confounding variables were adjusted with a Cox model. RESULTS: The hydrophobic IOL group comprised 80 patients and the hydrophilic IOL group, 76 patients. There were significantly more men in the hydrophobic group (51.3%) than in the hydrophilic group (30.7%) and patients were significantly younger in the hydrophobic group (63.0 years versus 65.8 years) (both P<.01). Eighteen months postoperatively, 4.4% of eyes in the hydrophobic group and 14.6% of eyes in the hydrophilic group required Nd:YAG laser capsulotomy. After 24 months, the respective rates were 8.8% and 37.2% (P<.0001). Eyes in the hydrophilic group had a 4.50-fold (2.28 versus 8.91) higher risk for Nd:YAG laser capsulotomy (P<.0001) that persisted after adjusting for age (relative risk 4.64, 2.32 to 9.29) (P<.0001). Patients younger than 63.5 years in the hydrophilic group were more likely to require Nd:YAG laser capsulotomy. CONCLUSION: Capsulotomy was significantly less frequent after hydrophobic IOL implantation than after hydrophilic IOL implantation 24 months postoperatively. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. An additional disclosure is found in the footnotes.

Measuring benefits and patients' satisfaction when glasses are not needed after cataract and presbyopia surgery: scoring and psychometric validation of the Freedom from Glasses Value Scale (FGVS).

BACKGROUND: The purpose of this study was to reduce the number of items, create a scoring method and assess the psychometric properties of the Freedom from Glasses Value Scale (FGVS), which measures benefits of freedom from glasses perceived by cataract and presbyopic patients after multifocal intraocular lens (IOL) surgery. METHODS: The 21-item FGVS, developed simultaneously in French and Spanish, was administered by phone during an observational study to 152 French and 152 Spanish patients who had undergone cataract or presbyopia surgery at least 1 year before the study. Reduction of items and creation of the scoring method employed statistical methods (principal component analysis, multitrait analysis) and content analysis. Psychometric properties (validation of the structure, internal consistency reliability, and known-group validity) of the resulting version were assessed in the pooled population and per country. RESULTS: One item was deleted and 3 were kept but not aggregated in a dimension. The other 17 items were grouped into 2 dimensions ('global evaluation', 9 items; 'advantages', 8 items) and divided into 5 sub-dimensions, with higher scores indicating higher benefit of surgery. The structure was validated (good item convergent and discriminant validity). Internal consistency reliability was good for all dimensions and sub-dimensions (Cronbach's alphas above 0.70). The FGVS was able to discriminate between patients wearing glasses or not after surgery (higher scores for patients not wearing glasses). FGVS scores were significantly higher in Spain than France; however, the measure had similar psychometric performances in both countries. CONCLUSIONS: The FGVS is a valid and reliable instrument measuring benefits of freedom from glasses perceived by cataract and presbyopic patients after multifocal IOL surgery.

Spectacle independence and subjective satisfaction of ReSTOR multifocal intraocular lens after cataract or presbyopia surgery in two European countries.

PURPOSE: To determine the percentage of patients implanted bilaterally with ReSTOR((R)) requiring spectacles at 18 months, the patient satisfaction, and factors that predict spectacles independence. METHODS: The medical and surgical data were collected from patient records. The 'Freedom from Spectacles Value Scale' (FGVS) was used to rank their experiences via telephone interview. A Bayesian network was used to predict postoperative spectacles use. RESULTS: 304 patients (65.6 years) were included. Postoperative visual acuity was >/=0.8 in 93.3% of patients for near vision and in 88.6% of patients for distance vision. After surgery, 87.2% of the patients were spectacles free. 88.2% of the patients rated their vision as being better following the surgery and 93.1% thought that surgery resulted in a positive change. FGVS mean scores (5 the most favorable rating) were: 'Practical Advantages' 3.8, 'Psychological Advantages' 3.8, 'Evaluation of the Result' 4.5, 'Feelings' 4.4, and 'Global Judgement' 4.4. Patients who stated that spectacles wear was particularly bothersome and those who thought that their appearance was more favorable without spectacles were 3 times more likely not to wear spectacles postoperatively. CONCLUSION: ReSTOR((R)) provides patients with good distance and near vision, a high rate of spectacles independence, and a high degree of patient satisfaction.