15 research outputs found

    Safety of an intracameral fixed combination for mydriasis and intraocular anaesthesia during cataract surgery

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    Purpose: 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/mmfor ICMA group versus 2241 ± 513 cells/mmfor 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

    Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program

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    Pierre-Jean Pisella,1 Marc Labetoulle,2 Serge Doan,3 Beatrice Cochener-Lamard,4 Mourad Amrane,5 Dahlia Ismail,5 Catherine Creuzot-Garcher,6,7 Christophe Baudouin8–10 1Department of Ophthalmology, Tours University Hospital, University François Rabelais, Bretonneau Hospital, Tours, 2Department of Ophthalmology, Bicêtre Hospital, APHP, Paris-Sud University, Le Kremlin-Bicêtre, 3Department of Ophthalmology, Bichat Hospital and Fondation A de Rothschild, Paris, 4Brest University Medical School, Morvan Hospital, Brest, 5Santen SAS, Evry, 6Department of Ophthalmology, University Hospital, 7Department of Ophthalmology III, Eye and Nutrition Research Group, Burgundy, Dijon, 8Research Team S12, Quinze-Vingts National Ophthalmology Hospital, 9Department of Ophthalmology, Ambroise-Paré Hospital, APHP, UPMC University, Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris, 10University of Versailles Saint-Quentin en Yvelines, Versailles, France Purpose: The objective of this study was to report the evaluation of efficacy and safety of cyclosporine A cationic emulsion (CsA CE) 0.1% for the treatment of severe keratitis in adults with dry eye disease (DED) in a French early-access program. Methods: Patients with DED and severe keratitis (corneal fluorescein staining [CFS] score of 3–5 on the Oxford scale and/or the presence of corneal lesions [filaments or ulcers]) were enrolled in a compassionate use program (Authorization for Temporary Use [ATU]) for once-daily CsA CE, which was approved by French health authorities prior to its registration. Efficacy and safety at 1, 3, 6, and 12-month follow-up visits were evaluated. Results: The ATU cohort (n=1,212; mean age =60.5 years; 79.5% female; 98.1% with severe keratitis; 74.5% with corneal lesions) consisted of 601 CsA-naïve patients and 611 patients treated previously with other CsA formulations. The primary DED etiology was Sjögren’s syndrome (48.7%). Clinical benefit could be discerned among 548 evaluable patients from months 1 to 12: keratitis improvement, 44.8% at month 1 and 42.1% at month 12; keratitis stabilization, 47.2% and 45.7%, respectively; symptom improvement, 47.2% and 48.6%; and symptom stabilization, 44.8% and 45.0%. Corneal clearing (CFS score =0) increased from 4.8% (month 1) to 11.4% (month 12). No unexpected safety concerns were identified; instillation site pain (10.2%) and eye irritation (7.8%) were the most common adverse events. Conclusion: The French ATU cohort provides supportive data on the clinical benefit of CsA CE in improving/stabilizing symptoms and corneal damage in DED patients with severe keratitis in real-world clinical practice. Keywords: dry eye, keratoconjunctivitis sicca, cyclosporine A, Sjögren’s syndrome, inflammation, cationic emulsion, severe keratitis, Ikervi

    Temperature rise during photo-activated disinfection of root canals.

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    The aim of this study was to determine whether it is safe to use photo-activated disinfection (PAD) during root canal treatment without heating the periodontal tissues. Root canals of 30 freshly extracted single-rooted teeth were prepared using ProFiles up to size ISO 40 and then filled with photo-sensitiser: tolonium blue (1.2 mg/l). The 635 nm diode laser was used with the manufacturer's endo-tip. Samples were irradiated for 150 s (output power 100 mW, approximate energy density 106.16 J/cm(2)). Temperatures were recorded at working length on the external root surface. After 150 s of PAD irradiation, the average temperature rise was 0.16 +/- 0.08 degrees C. All values were lower than the 7 degrees C safety level for periodontal injury. It was concluded that, regarding the temperature increase, the use of PAD in root canals could be considered harmless for periodontal tissues
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