Document Detail

Efficacy and tolerability of preservative-free and preserved diclofenac and preserved ketorolac eyedrops after cataract surgery.
MedLine Citation:
PMID:  20152959     Owner:  NLM     Status:  MEDLINE    
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.
Saskia M Maca; Michael Amon; Oliver Findl; Gunal Kahraman; Talin Barisani-Asenbauer
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-02-11
Journal Detail:
Title:  American journal of ophthalmology     Volume:  149     ISSN:  1879-1891     ISO Abbreviation:  Am. J. Ophthalmol.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-04-19     Completed Date:  2010-05-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370500     Medline TA:  Am J Ophthalmol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  777-84     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 Elsevier Inc. All rights reserved.
Department of Ophthalmology & Optometry, Medical University Vienna, Vienna, Austria.
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MeSH Terms
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*,  adverse effects
Benzalkonium Compounds / administration & dosage,  adverse effects
Diclofenac / administration & dosage*,  adverse effects
Intraocular Pressure / physiology
Ketorolac / administration & dosage*,  adverse effects
Lens Implantation, Intraocular
Middle Aged
Ophthalmic Solutions / administration & dosage,  adverse effects
Patient Satisfaction
Postoperative Complications / prevention & control*
Preservatives, Pharmaceutical / administration & dosage*,  adverse effects
Prospective Studies
Treatment Outcome
Visual Acuity / physiology
Reg. No./Substance:
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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