Antoine Lafuma

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.

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.

Estimation of direct unit costs associated with non-vertebral osteoporotic fractures in five European countries

The objective of this study was to estimate the unit costs of non-vertebral osteoporotic fractures in five European countries based on the results of the SOTI and TROPOS clinical trials in postmenopausal osteoporotic women. The information recorded in the Case Report Forms was used. The perspective of third party payers was adopted. Hip fracture unit cost was the highest. The ranges of costs among countries was narrow for hip from 8,346€ (Italy) to 9,907€ (France), but wider for other fractures: 890€ (Spain) to 2,022€ (Italy) for wrist, 1,167€ (Spain) to 3,268€ (Italy) for pelvis, 837€ (Spain) to 2,116€ (Italy) for sternum/clavicle, 565€ (Spain) to 908€ (France) for rib, 1,518€ (Spain) to 3,651€ (Belgium) for humerus, 1,805€ (Spain) to 3,521€ (Italy) for leg. The costs of those fractures should be considered when estimating the cost of osteoporosis.

The economic burden of glaucoma and ocular hypertension: implications for patient management: a review.

This paper reviews the burden and economic consequences of glaucoma upon healthcare systems and patients, especially elderly patients. An extensive review of the literature was conducted, primarily using MEDLINE, but also by examining selected article reference lists, relevant websites and the proceedings of specialised conferences. All relevant articles and documents were analysed.Glaucoma is characterised by destruction of the optic nerve. It is most often a continuous, chronic eye disease and the most frequent diagnosis is primary open angle glaucoma (POAG). POAG is mostly associated with intraocular hypertension which can be delayed by medication, surgery or laser therapy.The prevalence rate of glaucoma is about 1% in the population >50 years of age. The rate increases with age and is higher in Black and Hispanic populations. Glaucoma affects more than 67 million people worldwide. Cost-of-illness studies have shown the importance of this disease, on which more than £300 million was spent in the UK in 2002. Most of the costs (45%) were associated with direct medical costs, but direct nonmedical costs (20%) and indirect costs (35%) were also not negligible. Recent economic studies have shown a dramatic increase in the number of patients with glaucoma receiving treatment but a reduction in use of surgical procedures to treat the condition, especially as first-line therapy. The greater part of medical expenditure is now on medication, with new, more potent, better tolerated, but more costly drugs replacing older and less expensive medications. Treatment costs are directly related to the severity of disease and the number of different treatments used; they are also negatively correlated with treatment efficacy in reducing intraocular pressure. However, long-term economic benefits that may be associated with use of more potent new drugs (by delaying institutionalisation) have never been documented. Glaucoma screening has also been found not to be cost effective, although these results should be reconsidered in the light of new data.

Comparison of Nd : YAG capsulotomy rates following phacoemulsification with implantation of PMMA, silicone, or acrylic intra-ocular lenses in four European countries.

PURPOSE The aim of this study was to compare the incidence of Nd : YAG laser capsulotomy after cataract surgery according to the type of intra-ocular lens material (PMMA, silicone, hydrophilic acrylic, hydrophobic acrylic) implanted in four European countries (France, Italy, Germany, Spain). DESIGN A retrospective record review. PARTICIPANTS A review of 1525 patients (first operated eye), aged 50 to 80 years, operated on for cataract in 1996 or 1997 in 16 surgical centers (4 per country). METHODS The study employed a retrospective cohort design. Charts were reviewed to collect information during at least a three-year period following cataract surgery to identify patients who underwent Nd : YAG laser capsulotomy postoperatively. MAIN OUTCOME MEASURES Data on the type of intra-ocular lens implanted was extracted from the patient notes, as was the date and outcome of the Nd : YAG laser intervention. Kaplan-Meier survival curve analysis with the time to Nd : YAG laser was performed on the data. RESULTS A total of 1525 patients (first operated eye) were available for the study (n = 294 for hydrophilic acrylic, n = 384 for PMMA, n = 421 for hydrophobic acrylic, n = 426 for silicone). There was a highly statistically significant difference between the IOL groups for the incidence of posterior capsule opacification (p < 0.001) and for Nd : YAG laser treatment (p < 0.001). The mean delay of Nd : YAG laser treatment from the date of cataract operation was 2.48 years (±1.70, ranging from 0 to 5.88 years).The rate of Nd : YAG laser capsulotomy over the follow-up period was lowest in the hydrophobic acrylic group (7.1%), followed by silicone (16.2%), PMMA (19.3%) and hydrophilic acrylic (31.1%), respectively. CONCLUSIONS A low incidence of posterior capsular opacification (PCO) and Nd : YAG laser treatment was detected in hydrophobic acrylic IOLs in comparison to three other types of IOLs implanted in a large cohort of persons with age-related cataract. Choice of IOL type may reduce the need for Nd : YAG laser treatment, although further research on the reasons for this is needed.

Evaluation of Non-Medical Costs Associated with Visual Impairment in Four European Countries

IntroductionVisual impairment is a severe disability that puts a heavy burden on individuals, families and society. In developed countries, the two major diseases leading to irreversible visual impairment are glaucoma and age-related macular degeneration. Their prevalence will increase dramatically with population aging. The economic consequences of visual impairment are considerable, but have rarely been documented, apart from some ‘top-down’ estimates based on national statistics. We estimated the non-medical costs related to visual impairment in four European countries: France, Italy, Germany and the UK.MethodsPrevalence rates of visual impairment, defined according to local regulations, were taken from national registers and, for France, from two recent nationwide surveys conducted by the French Institute for National Statistics and Economic Studies (Institut National de la Statistique et des Etudes Economiques [INSEE]). Estimates of the number of non-registered persons were obtained from the literature and expert opinion. Estimates of non-medical costs included institutional care, non-medical devices, residential adaptations, burden on carer, paid home help, loss of income and social allowances related to visual impairment. Unit costs (year 2004) were extracted from national databases and manufacturers. Healthcare professionals were interviewed to estimate the duration of assistance required by visually impaired persons. These durations were used to evaluate the cost of paid assistance at home in the four countries.ResultsThe numbers of visually impaired persons were 1.27 million in France, 0.73 million in Germany, 1.03 million in Italy and 1.11 million in the UK, including, respectively, 56%, 11%, 80% and 72% non-registered persons. The frequency of institutionalisation for visually impaired persons were, respectively, 7.8%, 9.6%, 10.9% and 10%. Total annual costs for visually impaired persons were estimated at €10 749 million in France, €9214 million in Germany, €12 069 million in Italy and €15 180 million in the UK. This translated into average annual costs per affected individual of €8434, €12 662, €11 701 and €13 674, respectively. The main cost components of visual impairment in the community were ‘loss of income’ (23–43% of community costs), ‘burden on carer’ (24–39%) and ‘paid assistance’ (13–29%).ConclusionTotal non-medical costs associated with visual impairment are considerable. The present analysis demonstrates that the preponderant economic consequences of visual impairment lie beyond healthcare systems, and that visual impairment has a considerable negative impact on productivity. Considering the non-medical social dimensions of visual impairment related to the consequent incapacity and dependency should encourage payers to finance health innovations that aim to preserve vision.

Medical predictive factors of glaucoma treatment costs.

Purpose:To describe the patterns and the economics of glaucoma treatment. Patient and Methods:Ophthalmologists selected at random were asked to include 4 consecutive patients over 18 years of age seen in consultation during a week. Socio-demographics, general and eye comorbidities, glaucoma risk factors, clinical data, and medical item consumption data for the preceding 5 years were collected for each patient. The economic perspective was societal, and predictive medical factors of costs were identified using a stepwise regression. Results:Eighty-eight ophthalmologists included 337 patients, with a gender ratio of 4 males to 6 females, and a mean age of 62. Thirty-four percent had OHT. Glaucoma patients were older and no difference was found on the known confounding factors. Patients with glaucoma visited practitioners more often than those with OHT, had more exams, more often used expensive drug combination therapies, and had more hospitalizations. Drugs represented 37.1% to 63.1% of the expenses followed by exams (17.7% to 34.3%) and visits (13.8% to 28.0%). Two clinical factors contributed to costs: abnormalities of the optic nerve head the day of the study visit and the number of treatment changes. These were followed by intraocular pressure (IOP) and visual acuity. Conclusion:Two major independent factors explained the bulk of total cost variance: drug treatment changes and the presence of glaucoma instead of OHT. They contributed independently in an additive way to total cost.

Blindness, low vision, and other handicaps as risk factors attached to institutional residence

Aims: To estimate the risk of living in an institution and being visually impaired. Methods: Two national surveys were pooled: (1) 2075 institutions (for children or adults with handicaps, old people, and psychiatric centres) were selected randomly, in 18 predefined strata, from the French health ministry files. From these institutions, 15 403 subjects were selected randomly and handicap was documented by interview in 14 603 (94.9%) of them; (2) level of handicap was documented in a randomised, stratified sample of 356 208 citizens living in the community; from this sample, 21 760 subjects were further selected at random and 16 945 people were interviewed. Data on handicaps (visual, auditory, speech, brain, visceral, motor, and other) and activities of daily living (ADL) were extracted. The odds ratio (OR) of living in an institution was estimated, using stepwise logistic regressions with age, geographical area, handicaps, and ADL as co-variables. Results: Subjects in institutions, compared to those living at home, were, respectively, more often female (64.3% v 52.4%) and older (68.7 v 38.0 years); they more often had handicaps (ORs: speech, 6.59; brain, 10.17; motor, 8.86; visceral, 3.49; auditory, 2.66; other, 1.53); and were less often able to perform their ADL (46.2% v 97.1%) without assistance. Below 80 years, blind people were more often in institutions (ORs 0.239 to 0.306); whereas in older people the association was reversed (OR: 3.277). Low vision was always significantly associated with institutional residence (ORs from 0.262 to 0.752). Conclusion: Visual handicap was associated with institutional residence. The link persisted after adjustment for known confounding factors.

Medico-Economic Analysis of Diacerein With or Without Standard Therapy in the Treatment of Osteoarthritis

SummaryThis 9-month pragmatic study compared 2 therapeutic regimens in the management of osteoarthritis of the hip and knee. Patients received either diacerein 100 mg/day plus standard osteoarthritic therapy for 6 months, followed by a 3-month monitoring period without diacerein, or standard therapy alone for the entire 9-month period. A total of 207 patients with osteoarthritis of the knee and hip were enrolled.Improvements in Lequesne’s functional index and quality-of-life scores (revised Arthritis Impact Measurement Scales Health Status Questionnaire and Nottingham Health Profile), and decreases in nonsteroidal anti-inflammatory drug and analgesic consumption were significantly greater with diacerein plus standard therapy than with standard therapy alone. The overall assessment of therapy by patients was good or excellent for 60% of those who received diacerein plus standard therapy, compared with 26% who received standard therapy alone.Medical and paramedical procedures carried out in addition to those stipulated in the protocol (medical consultations, physiotherapy, nursing, etc.), osteoarthritis-related, were fewer and less costly in the diacerein plus standard therapy group than in the standard therapy group.The average outpatient cost (in 1995 French francs) of osteoarthritis treatment in the standard therapy group was FF2272 compared with FF2360 in the diacerein plus standard therapy group. The cost-effectiveness ratios per point scored on Lequesne’s index were FF1893 for the standard therapy group and FF1072 for the diacerein plus standard therapy group, leading to a saving of 43% with diacerein plus standard therapy. The marginal cost (additional cost corresponding to the clinical benefit obtained by adding diacerein to standard treatment) was FF88 per point scored on Lequesne’s index.

Prevalence and burden of self-reported blindness and low vision for individuals living in institutions: a nationwide survey

BackgroundThe prevalence of self-reported low vision (LV) and blindness, and their associated disabilities, handicaps and socio-economic consequences for individuals living in institutions are poorly documented.Methods2,075 institutions were selected at random and eight individuals were picked at random from the list of residents. Three groups of individuals were defined: blind, LV, and a control group (CG). These were compared after adjustment for age and co-morbidities. Of the 15,403 individuals, 14,603 interviews (94.9%) were completed.ResultsThe prevalence of blindness was 1.6% and the LV 13.4%. Blind individuals needed assistance more often (OR: 2.65 to 11.35) than CG members while the assistance required by LV individuals was similar to that for the CG. Blind individuals required institution adaptation (building and furniture changes) more often than the CG. Blind (57.9%) and LV individuals (35.4%) were more often registered for social allowances. Monthly social allowances were EUR 86 higher for blind than LV individuals. Monthly family incomes were found to be similar between the three groups (from EUR 782 to 797). Social and demographic data, institution description, income, handicaps, disabilities, social allowances and details of daily activities were collected interviewsConclusionThe results demonstrate the impact of self-reported blindness and LV on daily life for patients living in institutions.