Gilles Berdeaux

Vision related quality of life and topical glaucoma treatment side effects

BackgroundLocal tolerance of topical glaucoma treatment is important to achieve a good compliance. The aim of this study was to evaluate the consequences of local anti-glaucoma drug side effects on the vision-related quality of life (QoL).MethodsA mail survey was sent to 20,000 homes of a panel representative of the French population asking whether one member of the family was suffering from ocular hypertension (OHT) or glaucoma. (POAG) A computer-assisted telephone interviewing system was used to confirm self-reported glaucoma, to describe the disease and its treatment, and medical item consumption. Vision-related QoL was assessed with the NEI-VFQ-25 (National Eye Institute Visual – Function Questionnaire) and local tolerance with the COMTOL (Comparison of Ophthalmic Medications for TOLerability).Results13,352 homes (66.7%) answered the mail. 581 people declared they were suffering from glaucoma or OHT. Prevalence was 1.8%, increasing with age. 204 patients were selected at random Their NEI-VFQ-25 global score showed an overall good QoL. Two domain scores showed some deterioration: general health and driving. 62.4% of the patients cited at least one local side effect. 25.4% had burning, 20.8% blurred vision and 20.2% tearing. Poor vision related QoL was associated with the presence of local side effects leading to poor perceived treatment satisfaction. Dissatisfied patients visited their ophthalmologist more frequently.ConclusionBased on a representative French sample, poor vision related QoL was associated with topical drug side effects that also impact patient satisfaction and compliance. Longitudinal data collection should be performed to confirm our findings.

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.

Psychometric validation of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) French version : in a population of patients treated for ocular hypertension and glaucoma

AbstractObjective: Physicians need reliable, valid and sensitive questionnaires to assess QOL related to glaucoma or ocular hypertension. This article presents the psychometric properties of the French version of the National Eye Institute Visual Function Questionnaire — 25 (NEI VFQ-25). Methods: A mail survey was sent to 20 000 households. The survey identified 581 residents with glaucoma or ocular hypertension. Of these a random sample (n = 204) took part in a telephone survey during which the NEI VFQ-25 was completed by eligible patients (those taking at least one topical treatment for glaucoma or ocular hypertension on the day of the interview). Multi-trait analysis was performed to assess the construct validity of the questionnaire. Internal consistency reliability was assessed using Cronbach’s α and the average inter-item correlation. Known groups validity was assessed by comparing patients grouped by duration of glaucoma, adjusted for age and gender. Results: One hundred and seventy-three patients participated in the survey. Analysis of convergent validity showed that all of the items in each scale correlated above 0.40 with their own scale except for the ‘driving’ scale. The success rate of the discriminant validity ranged from 57.1% to 100% except for the ‘driving’ scale, which was 7.1%. Cronbach’s α coefficients were all above 0.70 except the ‘driving’ score. Participants with glaucoma for less than 20 years consistently had better ‘global’, ‘near vision’, ‘distant vision’, ‘driving’, ’social function’ and ‘peripheral vision’ scores than those with disease of 20+ years duration, indicating better QOL in patients with a shorter disease duration. Conclusion: The NEI VFQ-25 is a validated instrument to measure vision-targeted QOL in French populations with glaucoma.

Adverse clinical consequences of neodymium:YAG laser treatment of posterior capsule opacification ☆ ☆☆

Purpose: To evaluate the clinical consequences of complications from neodymium:YAG (Nd:YAG) laser capsulotomy for posterior capsule opacification (PCO) over the lives of cataract patients. Setting: CHU de Caen, Caen, France. Methods: A model was constructed to estimate the lifetime clinical consequences of postoperative PCO treated by Nd:YAG laser capsulotomy. The probability of death was modeled from French mortality tables as a polynomial function of sex and age. The probability of becoming blind was modeled as a function of age from data in the literature. The incidence of Nd:YAG complications came from the literature. The rate of Nd:YAG capsulotomy over time was modeled as a survival curve using data from a cohort of 3335 patients. Results: Over 9 years in a 70‐year‐old population, switching from an IOL with a 20% Nd:YAG capsulotomy rate at 3 years to an IOL with a 5% rate would avoid 1 chronic intraocular pressure increase requiring medical follow‐up in every 54 surgeries, 1 case of glaucoma in every 237 surgeries, 1 case of cystoid macular edema in every 265 surgeries, and 1 retinal detachment in every 265 surgeries. A 3‐year clinical study would only capture one‐third to one‐half of long‐term adverse events of Nd:YAG capsulotomy. Conclusion: Reducing PCO and the associated use Nd:YAG laser capsulotomy may contribute to preserving visual acuity in patients over their lifetimes.

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.

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.

Postcataract acute endophthalmitis in France : National prospective survey

PURPOSE: To report results of the National French Observational Database for Endophthalmitis (Observatoire National Des Endophtalmies [ONDE]). SETTING: Departments of ophthalmology at universities, general hospitals, and private clinics. METHODS: In this multicenter national interventional case series, data were collected prospectively between March 1, 2003, and November 1, 2004, from French ophthalmologists who answered a standardized 175‐item questionnaire. The data were from patients with acute‐onset endophthalmitis after cataract surgery. Before surgery, all 105 patients had received an official information card from the French Ophthalmological Society and provided written informed consent. RESULTS: The study comprised 105 patients. The median time from cataract extraction to endophthalmitis was 4 days (range 1 to 39 days). All but 1 patient had symptoms, with blurred vision being the most common. Initial visual acuity was 5/200 or better in 18.9% (18/95) of patients. Intraocular samples from 90.5% (95/105) of patients yielded 45 pathogens, of which 86.7% were gram positive. Treatments included intraocular antibiotic injections in 95.1% (98/103) of patients, intraocular steroid injections in 41.4% (41/99) of patients, and immediate vitrectomy in 14.0% (14/100) of patients. Visual acuity at 3 months was 20/100 in 64% of patients. CONCLUSIONS: The ONDE study disclosed important changes in French ophthalmic surgical practice 15 years after the first prospective endophthalmitis survey and 12 years after a United States study were published. Progress toward standardization of preventive methods (eg, patient information, increased systemic antibiotic efficacy, more frequent corticosteroid use) has contributed to fewer vitrectomies.