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.
RCT Entities:
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.
Authors: Hyun Kyung Kim; Jin A Choi; Hironori Uehara; Xiaohui Zhang; Balamurali K Ambati; Yang Kyung Cho Journal: Cornea Date: 2013-12 Impact factor: 2.651
Authors: Mehdi Roozbahani; Kristin M Hammersmith; Christopher J Rapuano; Parveen K Nagra; Qiang Zhang Journal: Int Ophthalmol Date: 2019-06-18 Impact factor: 2.031
Authors: Qing Pan; Qingguo Xu; Nicholas J Boylan; Nicholas W Lamb; David G Emmert; Jeh-Chang Yang; Li Tang; Tom Heflin; Saeed Alwadani; Charles G Eberhart; Walter J Stark; Justin Hanes Journal: J Control Release Date: 2015-01-08 Impact factor: 9.776
Authors: Lokendrakumar C Bengani; Hidenaga Kobashi; Amy E Ross; Hualei Zhai; Borja Salvador-Culla; Rekha Tulsan; Paraskevi E Kolovou; Sharad K Mittal; Sunil K Chauhan; Daniel S Kohane; Joseph B Ciolino Journal: Acta Biomater Date: 2020-08-16 Impact factor: 8.947
Authors: Anna Song; Rashmi Deshmukh; Haotian Lin; Marcus Ang; Jodhbir S Mehta; James Chodosh; Dalia G Said; Harminder S Dua; Darren S J Ting Journal: Front Med (Lausanne) Date: 2021-07-07