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Le Kremlin-Bicêtre, France

Baudouin C.,Quinze Vingts National Ophthalmology Hospital | Baudouin C.,French Institute of Health and Medical Research | Baudouin C.,University of Versailles | Aragona P.,Messina University | And 7 more authors.
British Journal of Ophthalmology | Year: 2014

Dry eye disease (DED) is a distressing ocular condition. Due to its multifactorial nature, clinical and biological signs of DED can be inconsistent and sometimes discordant with symptomatology. Consequently, no gold-standard model for determining DED severity exists. This can impact treatment decisions and complicate evaluation of disease progression, particularly within the stringent context of clinical trials. The multinational ODISSEY European Consensus Group is comprised of ophthalmologists who contend with ocular surface disease issues on a daily basis. This group convened to establish a clear and practical algorithm for evaluation and diagnosis of severe DED. Using a consensus-based approach, they assessed 14 commonly used DED severity criteria. The panel agreed that following confirmed DED diagnosis, just two criteria, symptom-based assessment and corneal fluorescein staining were sufficient to diagnose the presence of severe DED in the majority of patients. In the event of discordance between signs and symptoms, further evaluation using additional determinant criteria was recommended. This report presents the ODISSEY European Consensus Group recommended algorithm for DED evaluation, which facilitates diagnosis of severe disease even in the event of discordance between signs and symptoms. It is intended that this algorithm will be useful in a clinical and developmental setting.

M'Garrech M.,Hopital de Bicetre | Rousseau A.,Hopital de Bicetre | Kaswin G.,Hopital de Bicetre | Sauer A.,Hopitaux Universitaires Of Strasbourg | And 5 more authors.
Ophthalmology | Year: 2013

Purpose: To assess the impact of recurrent unilateral herpetic keratitis (HK) on the tear secretion of the unaffected fellow eye. Design: Prospective, noninterventional study. Participants and Controls: Thirty-five patients with a history of recurrent unilateral HK (clinically quiescent for at least 3 months) (HK group) and 35 patients who were age- and sex-matched with no history of corneal disease (control group). Methods: Tear osmolarity, tear instability (tear break-up time [TBUT]), tear reflex (Schirmer's I test), and central corneal sensitivity with the Cochet-Bonnet esthesiometer (Luneau, France) were measured in the HK and control groups. Main Outcome Measures: Tear osmolarity, TBUT, Schirmer's I, and central corneal sensitivity were compared between the affected and unaffected eyes of the HK and control groups. Results: Tear osmolarity and tear secretion reflex were similar between the affected and unaffected eyes of the HK group. Corneal sensitivity and TBUT were statistically lower in the affected eyes compared with the unaffected eyes in the HK group (P = 0.001 and P < 0.001, respectively). The central corneal sensitivity of unaffected eyes in the HK group was not significantly different from that in the control group (P > 0.05). The tear stability and tear secretion reflex were decreased and tear osmolarity was increased in the unaffected eyes of the HK group compared with the control group (P < 0.05, all cases). The difference between unaffected and control eyes varied according to the type of HK. All 4 tests were modified in patients with neurotrophic keratitis (KN). In the keratouveitis subgroup, only corneal sensitivity was normal, whereas Schirmer's I results were also normal in patients with archipelago keratitis. Tear osmolarity was consistently affected in both eyes of herpetic patients. Conclusions: Tear function is impaired in the unaffected eyes of patients with unilateral recurrent HK, even when the disease is apparently quiescent. The higher severity of results in the unaffected fellow eye of patients with KN in comparison with other herpes subgroups suggests that recurrent HK induces a reduction in the afferent pathways of the tear secretion reflex from the affected eye, leading to tear dysfunction in the unaffected eye. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. © 2013 by the American Academy of Ophthalmology.

Brignole-Baudouin F.,University of Paris Descartes | Brignole-Baudouin F.,French Institute of Health and Medical Research | Brignole-Baudouin F.,University Pierre and Marie Curie | Brignole-Baudouin F.,French National Center for Scientific Research | And 10 more authors.
Acta Ophthalmologica | Year: 2011

Purpose: To determine whether oral supplementation with omega-3 and omega-6 fatty acids can reduce conjunctival epithelium expression of the inflammatory marker human leucocyte antigen-DR (HLA-DR) in patients with dry eye syndrome (DES). Methods: This 3-month, double-masked, parallel-group, controlled study was conducted in nine centres, in France and Italy. Eligible adult patients with mild to moderate DES were randomized to receive a placebo containing medium-chain triglycerides or treatment supplement containing omega-3 and omega-6 fatty acids, vitamins and zinc. Treatment regimen was three capsules daily. Impression cytology (IC) was performed at baseline and at month 3 to assess the percentage of cells expressing HLA-DR and to evaluate fluorescence intensity, an alternate measure of HLA-DR. Dry eye symptoms and objective signs were also evaluated. Analyses were performed on the full analysis set (FAS) and per-protocol set (PPS). Results: In total, 138 patients were randomized; 121 patients with available IC were included in the FAS, and of these, 106 patients had no major protocol deviations (PPS). In the PPS, there was a significant reduction in the percentage of HLA-DR-positive cells in the fatty acids group (p = 0.021). Expression of HLA-DR as measured by fluorescence intensity quantification was also significantly reduced in the fatty acids group [FAS (p = 0.041); PPS (p = 0.017)]. No significant difference was found for the signs and symptoms, but there was a tendency for improvement in patients receiving the fatty acids treatment. Conclusion: This study demonstrates that supplementation with omega-3 and omega-6 fatty acids can reduce expression of HLA-DR conjunctival inflammatory marker and may help improve DES symptoms. © 2011 The Authors. Acta Ophthalmologica © 2011 Acta Ophthalmologica Scandinavica Foundation.

Falissard B.,South Paris University | Izard V.,Hopital Sainte Marguerite | Xerri B.,Hopital Sainte Marguerite | Bouvenot G.,Hopital Sainte Marguerite | And 2 more authors.
International Journal of Technology Assessment in Health Care | Year: 2010

Objectives: Post-listing assessment of pharmaceuticals depends on national habits. In England, the assessment is based on estimates of cost per quality-adjusted life-year. These are made some considerable time after listing (negative list). In France, effectiveness, and then efficiency, is assessed immediately after listing (positive list). We propose a new formal methodthe REAL methodthat can help make early comparisons of the effectiveness of medical treatments. Methods: Relative efficacies are first obtained from randomized controlled trials (RCTs). Members of the Transparency Committee (French National Authority for Health) are then consulted by questionnaire on the transposability of these results to real life. The RCT results and experts ratings are entered into an effect model to obtain estimates of relative effectiveness, using unidimensional scaling, and bootstrap procedures. Results: Application of the REAL method to the example of a new drug to treat Parkinson's disease and three comparators used in the same indication provided graphs of the distributions of their relative efficacy and relative effectiveness. The new drug was found to provide no added value. Conclusions: The REAL method is a rational, transparent, and practical procedure for comparing the effectiveness of pharmaceuticals in an immediate post-listing setting. © 2010 Cambridge University Press.

van Setten G.,Karolinska Institutet | Labetoulle M.,South Paris University | Baudouin C.,Quinze Vingts National Ophthalmology Hospital Paris | Rolando M.,University of Genoa
Acta Ophthalmologica | Year: 2016

Purpose: Current models consider the development of dry eye disease (DED) as a more or less continuous process with only minor daily variations. Clinical evidence, however, does suggest the existence of phase-like recurring dry eye complaints that may be linked to seasonal environmental conditions. In this survey-based study, we examined the influence of seasonality in dry eye pathophysiology. Methods: A specific protocol for a telephone interview was created. Then, 738 patients suffering from dry eye and/or Sjögren's syndrome were interviewed and asked about the impact of the four seasons and other weather conditions on their ocular symptoms. Data were statistically analysed. All data were compared in respect to the relation between season, gender, country of origin and the presence of comorbidities. Results: Overall, 47% of respondents stated that seasonal conditions had a high impact on their DED symptoms, with only 15% reporting that there was no seasonal impact on their symptoms. Wind was the most commonly reported weather condition to impact dry eye symptoms (for 71% of patients), followed by sunshine (60%) and heat (42%). Cold weather was also reported to aggravate dry eye sensation by 34% of patients. The two seasons most commonly associated with dry eye complaints were summer and winter (for 51% and 43% of patients, respectively). Only 8% stated that no weather conditions affected their symptoms. Discussion: This study confirms the seasonal enhancement of dry eye sensations and symptoms. Environmental characteristics such as cold and heat as well as wind were the most commonly cited triggering factors. Geographical differences do exist between the countries surveyed and the seasonal peak of complaints appears related to temperature and humidity. The main seasons of dry eye complaints in Europe were winter and summer. Such seasonal characteristics in ocular surface disease should be kept in mind when considering diagnosis and treatment as well when investigating the ocular surface. Conclusion: Our study confirmed high prevalence of both seasonal and weather-related enhancement of dry eye sensations and symptoms. © 2016 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd

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