Efficacy and Safety of Long-term Corticosteroid Eye Drops after Penetrating Keratoplasty: A Prospective, Randomized, Clinical Trial

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• 作者：Jun Shimazaki ; MD ; PhD¹ ; ² ; ^{jun@eyebank.or.jp} ; Ayumi Iseda ; MD¹ ; ³ ; Yoshiyuki Satake ; MD ; PhD¹ ; Seika Shimazaki-Den ; MD ; PhD¹
• 刊名：Ophthalmology
• 出版年：2012
• 出版时间：April, 2012
• 年：2012
• 卷：119
• 期：4
• 页码：668-673
• 全文大小：277 K

文摘

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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¡À4.5 (mean ¡À 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.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any of the materials discussed in this article.