title: Efficacy and safety of long-term corticosteroid eye drops after penetrating keratoplasty: a prospective, randomized, clinical trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Randomized, nonblinded, clinical trial.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.affiliation: Department of Ophthalmology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan. jun@eyebank.or.jp
authors.forename: Jun
authors.initials: J
authors.lastname: Shimazaki
authors.forename: Ayumi
authors.initials: A
authors.lastname: Iseda
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Satake
authors.forename: Seika
authors.initials: S
authors.lastname: Shimazaki-Den
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002386:Cataract / Q000503:physiopathology; D003315:Cornea / Q000502:physiology; D004728:Endothelium, Corneal / Q000187:drug effects; D005260:Female; D005469:Fluorometholone / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D015948:Keratoplasty, Penetrating; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D005469:Fluorometholone