Search

Rudy MMA Nuijts,1 Béatrice Cochener-Lamard,2 Jacek P Szaflik,3 Rita Mencucci,4 Frédéric Chiambaretta,5 Anders Behndig6 1University Eye Clinic, Maastricht University Medical Center, Maastricht, the Netherlands; 2Ophthalmology Department, CHU Morvan, University Hospital of Brest, and University of Bretagne Occidentale (UBO), Brest, France; 3Department of Ophthalmology, Medical University of Warsaw, Warszawa, Poland; 4Eye Clinic, Department of Neurosciences, Psychology, Pharmacology, and Child Health, University of Florence, Florence, Italy; 5Ophthalmology Department, CHU Gabriel Montpied, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; 6Department of Clinical Sciences/Ophthalmology, Umea University, Umea, SwedenCorrespondence: Anders Behndig, Department of Clinical Sciences/Ophthalmology, Umea University, SE-901 85 Umea, Sweden, Tel + 46 70 782 75 36, Fax + 46 90 13 34 99, Email anders.behndig@umu.sePurpose: To compare the safety of a standardized, commercially available intracameral combination of mydriatics and anesthetic (ICMA) with a reference topical mydriatic regimen for cataract surgery.Patients and Methods: The safety results from two international, randomized, controlled clinical studies were combined to compare ICMA at the beginning of cataract surgery (ICMA group) to the reference topical mydriatic regimen (reference group). Data were collected on ocular and systemic adverse events, corneal and anterior chamber examination, endothelial cell density, retinal thickness and visual acuity. Analysis was performed on a pooled safety set from both studies, preoperatively and up to 1 month postoperatively.Results: 342 patients received ICMA and 318 the reference topical regimen. Ocular adverse events were reported in 17.0% of patients in the ICMA group and 18.6% in the reference group. No difference was shown between groups in endothelial cell density (2208 ± 498 cells/mm2 for ICMA group versus 2241 ± 513 cells/mm2 for the reference group; p=0.547) and retinal thickness (change from baseline less than 50 μm in 94.7% versus 95.0% of patients, respectively) at 1 month postoperatively. At 1-day post-surgery, less patients in the ICMA group had moderate or severe (Grades 2 and 3) superficial punctate corneal staining (3.9% versus 7.0% for the reference group; p=0.064). Postoperatively, some ocular symptoms were also less frequently reported in the ICMA group. Best-corrected visual acuity increased in 96.0% of patients in the ICMA group and 95.8% in the reference group at 1 month.Conclusion: ICMA injection at the beginning of cataract surgery was demonstrated to be safe and may also provide perioperative and postoperative advantages over the standard topical mydriatic regimen.Keywords: cataract surgery, intracameral mydriasis, topical mydriasis, safety, tolerability

Jose Guell,1 Anders Behndig,2 Uwe Pleyer,3 Stéphane Jaulerry,4 Pascal Rozot,5 Pierre-Jean Pisella,6 Pierre-Yves Robert,7 Ines Lanzl,8 Sayeh Pourjavan,9 Carlos Aguiar,10 Joaquin Fernandez,11 Gunther Grabner,12 Rita Mencucci,13 Frédéric Chiambaretta,14 Marc Labetoulle15 On behalf of the Intracameral Mydrane (ICMA) and Ethics Group 1Cornea and Refractive Surgery Unit, Instituto de Microcirugía Ocular, Barcelona, Spain; 2Department of Clinical Science/Ophthalmology, Umeå University Hospital, Umeå, Sweden; 3Universitäts-Augenklinik, Charité Campus Virchow-Klinik, Berlin, Germany; 4Centre Hospitalier de Bigorre, Tarbes, France; 5Clinique Monticelli, Marseille, France; 6Hôpital Bretonneau, CHRU de Tours, Tours, France; 7Hôpital Dupuytren, CHU de Limoges, Limoges, France; 8Chiemsee Augen Tagesklinik, Prien, Germany; 9Cliniques Universitaires Saint-Luc, Bruxelles, Belgium; 10Hospital de Santo Antonio, Porto, Portugal; 11Hospital Torrecárdenas, Almeria, Spain; 12Universitätsklinik Für Augenheilkunde Und Optometrie, Der Paracelsus, Austria; 13AOU Careggi, Clinica Oculistica, Università Degli Studi di Firenze, Firenze, Italy; 14Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France; 15Hôpital Bicêtre, Université Paris Sud, Paris, France Objective: The objective of this study was to compare systemic exposure to tropicamide/phenylephrine following intracameral or topical administration before cataract surgery. Patients and methods: Mydriatics exposure was calculated in patients randomized to intracameral fixed combination of mydriatics and anesthetic ([ICMA]: tropicamide 0.02%, phenylephrine 0.31%, and lidocaine 1%, N=271) or mydriatic eye drops ([EDs]: tropicamide 0.5% and phenylephrine 10%, N=283). Additional doses were permitted if required. Mydriatic plasma levels were determined by mass spectrometric HPLC in 15 patients per group before and after administration.Results: Most ICMA patients (73.6%) received a single dose (200 µL) representing an exposure to tropicamide of 0.04 mg and phenylephrine of 0.62 mg. None of these patients received additional mydriatics. In the control group (three administrations), the exposure was 0.45 (11.3-fold higher than ICMA) and 10.2 (16.5-fold higher) mg. When additional ED was used in this group (9.2% of patients), it was 37.5-fold higher for tropicamide (10 drops, 1.5 mg) and 54.8-fold higher for phenylephrine (10 drops, 34 mg) than the recommended ICMA dose. Tropicamide plasma levels were not detectable at any time point in ICMA patients while it was detectable in all ED patients at 12 and 30 minutes. Phenylephrine was detectable in 14.3% of ICMA patients compared to all ED patients at least at one time point. More ED patients experienced a meaningful increase in blood pressure and/or heart rate (11.2% vs 6.0% of ICMA patients; P=0.03).Conclusion: Systemic exposure to tropicamide/phenylephrine was lower and cardiovascular (CV) effects were less frequent with ICMA. This could be of particular significance in patients at CV risk. Keywords: cataract surgery, intracameral mydriasis, topical mydriasis, systemic influence, cardiovascular safety

Carole Burillon,1 Frederic Chiambaretta,2 Pierre-Jean Pisella3 1Ophthalmology Department, University Hospital HCL, GH Edouard Herriot, Lyon, France; 2Ophthalmology Department, Clermont-Ferrand University Hospital, Hôpital Gabriel Montpied, Clermont Ferrand, France; 3Ophthalmology Department, Paris Nord Val-de-Seine University Hospitals, Hôpital Bretonneau, Tours, France Background: Dry eye disease (DED) is characterized by a loss of homeostasis of the tear film. It goes along with ocular symptoms, in which ocular surface inflammation and damage play etiological roles. High-mobility group box 1 protein (HMGB1) is a pro-inflammatory protein found in the tear fluid during conjunctivitis, blepharitis and DED. Glycyrrhizin binds to HMGB1, inhibiting cytokine activities, thus potentially improving DED.Aim: To assess the efficacy and tolerance of glycyrrhizin in moderate DED.Methods: Multicenter, open-label, prospective, nonrandomized clinical pilot study of glycyrrhizin 2.5% eye drops twice daily over 28 days in adult patients with moderate DED using standard evaluation parameters.Results: The overall mean age of the 37 patients included was 59.6±19.0 years, 70.3% of the patients were female and 77.0% of the patients had an Oxford score of II. After 28 days, 60.8% of the patients had an Oxford score of 0 or I; a significant mean improvement in the score of 0.97±0.86 (P

Dominique Bremond-Gignac,1,2 Riadh Messaoud,3 Sihem Lazreg,4 Claude Speeg-Schatz,5 Didier Renault,6 Frédéric Chiambaretta7,8 On behalf of the Azithromycin Pediatric Study Group 1Ophthalmology Department, Centre St Victor, University Hospital of Amiens, Picardie Jules Verne University, Amiens, France; 2CNRS FR3636, Paris V University, France; 3Ophthalmology Department, Tahar Sfar University Hospital, Mahdia, Tunisia; 4Dar El Beida, Blida, Algeria; 5Ophthalmology Department, University Hospital of Strasbourg, Strasbourg, France; 6Laboratoires THÉA, Clermont-Ferrand, France; 7Ophthalmology Department, University Hospital of Clermont-Ferrand, Gabriel Montpied Hospital, Clermont-Ferrand, France; 8EA 7281 R2D2, Auvergne University, Clermont-Ferrand, France Purpose: To compare the efficacy of azithromycin 1.5% versus tobramycin 0.3% eyedrops on clinical ocular signs and symptoms of bacterial conjunctivitis in children and to assess the parents’ satisfaction regarding the dosing regimen.Patients and methods: An international, multicenter, randomized, investigator-masked, controlled clinical trial conducted in children (1 day to 18 years old) with bulbar conjunctival hyperemia and purulent discharge. Azithromycin 1.5% was administered as 1 drop twice daily for 3 days, and tobramycin 0.3% as 1 drop every 2 hours for 2 days, then 4 times daily for 5 days.Results: A total of 286 patients (mean age: 3.2 years) were enrolled. In children with bacteriologically positive cultures (N=203), azithromycin produced a significantly greater improvement in conjunctival discharge (P