| Efficacy and safety of long-term corticosteroid eye drops after penetrating keratoplasty: a prospective, randomized, clinical trial. | |
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MedLine Citation:
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PMID: 22264885 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: Endothelial rejection remains a major cause of graft failure after penetrating keratoplasty (PKP). Topical corticosteroids are the gold standard for preventing rejection; however, protocols for corticosteroid treatment have been diverse. The aim of the present study was to examine the efficacy and safety of long-term use of corticosteroid eye drops after PKP in a randomized, clinical trial. DESIGN: Randomized, nonblinded, clinical trial. PARTICIPANTS: We enrolled 42 patients (21 males and 21 females) with a mean age of 65.3 years who underwent PKP and maintained graft clarity for >1 year with topical steroid eye drops. INTERVENTION: Patients were randomly assigned to 1 of 2 groups: Administration of 0.1% fluorometholone 3 times a day (steroid group) or discontinuation of steroid eye drops (no steroid group). All patients were followed for 12 months. MAIN OUTCOME MEASURES: Proportion of eyes without endothelial rejection and the proportion of eyes with clear grafts and the incidence of local or systemic side effects. RESULTS: Of the initial 42 patients, 4 in the steroid group and 6 in the no steroid group did not complete the trial. Of the patients who completed the trial, 1 patient in the steroid group and 6 in the no steroid group developed endothelial rejection at an average of 5.2±4.5 (mean ± standard deviation) months after study enrollment. The difference in the incidence of rejection between groups was found to be significant by both chi-square (P = 0.027) and Kaplan-Meier analyses (log-rank test, P = 0.032). No difference was observed between the 2 groups in visual acuity, intraocular pressure, epithelial damage, tear-film break-up time, cataract progression, infection, or incidence of systemic side effects. CONCLUSIONS: Prolonged use of 0.1% fluorometholone was beneficial for the prevention of rejection after PKP. Because no adverse consequences were noted, we recommend continuing use of the low-dose corticosteroids, even in non-high-risk cases. |
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Authors:
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Jun Shimazaki; Ayumi Iseda; Yoshiyuki Satake; Seika Shimazaki-Den |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial Date: 2012-01-20 |
Journal Detail:
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Title: Ophthalmology Volume: 119 ISSN: 1549-4713 ISO Abbreviation: Ophthalmology Publication Date: 2012 Apr |
Date Detail:
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Created Date: 2012-04-04 Completed Date: 2012-05-17 Revised Date: 2013-01-21 |
Medline Journal Info:
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Nlm Unique ID: 7802443 Medline TA: Ophthalmology Country: United States |
Other Details:
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Languages: eng Pagination: 668-73 Citation Subset: IM |
Copyright Information:
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Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Department of Ophthalmology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan. jun@eyebank.or.jp |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Topical Adult Aged Aged, 80 and over Cataract / physiopathology Cornea / physiology Endothelium, Corneal / drug effects Female Fluorometholone / administration & dosage*, adverse effects Follow-Up Studies Glucocorticoids / administration & dosage*, adverse effects Graft Rejection / prevention & control* Graft Survival / drug effects Humans Intraocular Pressure / drug effects Keratoplasty, Penetrating* Male Middle Aged Ophthalmic Solutions / administration & dosage, adverse effects Prospective Studies Treatment Outcome Visual Acuity / drug effects Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Glucocorticoids; 0/Ophthalmic Solutions; 426-13-1/Fluorometholone |
| Comments/Corrections | |
Comment In:
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Ophthalmology. 2012 Dec;119(12):2652; author reply 2652
[PMID:
23207033
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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