| Efficacy and tolerability of preservative-free and preserved diclofenac and preserved ketorolac eyedrops after cataract surgery. | |
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MedLine Citation:
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PMID: 20152959 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To compare the anti-inflammatory efficacy and subjective tolerability of preservative-free and preserved diclofenac 0.1% and preserved ketorolac 0.5% eye drops for prophylaxis and management of inflammation after cataract surgery. DESIGN: Prospective, randomized, investigator-masked, parallel-group, comparative clinical trial. METHODS: One hundred two patients who underwent small-incision phacoemulsification cataract surgery in an institutional setting were assigned randomly to receive preservative-free diclofenac sodium 0.1% (Voltaren ophtha SDU; Novartis Pharma), preserved diclofenac sodium 0.1% (Voltaren ophtha; Novartis Pharma), or preserved ketorolac tromethamine 0.5% (Acular; Pharm Allergan) eyedrops 4 times daily for 4 weeks after surgery. During the 1-month follow-up, anterior chamber flare and mean foveal thickness were evaluated for objective comparison of the anti-inflammatory effect. Ocular tolerability was assessed by observer-based grading of conjunctival hyperemia and ocular discomfort, as well as obtaining subjective ratings of ocular tolerability on a visual analog scale. Distance and near visual acuity and intraocular pressure served as safety measures. RESULTS: All 3 formulations demonstrated equal anti-inflammatory efficacy as measured by reduction of anterior chamber flare after surgery and prevention of postoperative macular edema. Patients treated with preservative-free diclofenac eyedrops reported significantly better subjective tolerability values (P = .001), were classified as having less ocular discomfort (P < .001), and experienced earlier reduction of postoperative conjunctival hyperemia (P = .029). CONCLUSIONS: Anti-inflammatory efficacy was comparable for all 3 agents. However, preservative-free diclofenac 0.1% eyedrops exhibited a significantly better postoperative subjective and objective tolerability when compared with preserved eyedrops containing ketorolac or diclofenac. |
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Authors:
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Saskia M Maca; Michael Amon; Oliver Findl; Gunal Kahraman; Talin Barisani-Asenbauer |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-02-11 |
Journal Detail:
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Title: American journal of ophthalmology Volume: 149 ISSN: 1879-1891 ISO Abbreviation: Am. J. Ophthalmol. Publication Date: 2010 May |
Date Detail:
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Created Date: 2010-04-19 Completed Date: 2010-05-06 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0370500 Medline TA: Am J Ophthalmol Country: United States |
Other Details:
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Languages: eng Pagination: 777-84 Citation Subset: AIM; IM |
Copyright Information:
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Copyright 2010 Elsevier Inc. All rights reserved. |
Affiliation:
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Department of Ophthalmology & Optometry, Medical University Vienna, Vienna, Austria. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*, adverse effects Benzalkonium Compounds / administration & dosage, adverse effects Diclofenac / administration & dosage*, adverse effects Female Humans Intraocular Pressure / physiology Ketorolac / administration & dosage*, adverse effects Lens Implantation, Intraocular Male Middle Aged Ophthalmic Solutions / administration & dosage, adverse effects Patient Satisfaction Phacoemulsification* Postoperative Complications / prevention & control* Preservatives, Pharmaceutical / administration & dosage*, adverse effects Prospective Studies Treatment Outcome Visual Acuity / physiology |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 0/Benzalkonium Compounds; 0/Ophthalmic Solutions; 0/Preservatives, Pharmaceutical; 15307-86-5/Diclofenac; 66635-83-4/Ketorolac |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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