title: Prospective, randomized study of the efficacy of systemic cyclosporine in high-risk corneal transplantation.
abstract: OBJECTIVE
  Immunologic rejection remains a major cause of graft failure in high-risk corneal transplantation. This study was conducted to elucidate the efficacy and safety of systemic cyclosporine (CsA) in high-risk corneal transplantation.
  
  
  METHODS
  Prospective, randomized, open-labeled clinical trial with a parallel-group study.
  
  
  METHODS
  Patients underwent high-risk corneal transplantation at the Department of Ophthalmology, Tokyo Dental College, Chiba, Japan. High-risk was defined as corneal neovascularization in more than 1 quadrant or a history of corneal grafting. Patients were assigned to either a systemic CsA group or a control group. Administration of CsA was continued for at least 6 months with blood CsA concentration 2 hours after administration of approximately 800 ng/mL, unless undesirable side effects developed. The main outcome measures were graft clarity, endothelial rejection, and local and systemic complications.
  
  
  RESULTS
  Forty patients were enrolled and 39 (18 men, 21 women; mean age, 67.4 ± 11.9 years) were analyzed. In the CsA group, CsA was discontinued within 6 months in 7 patients because of side effects. With a mean follow-up of 42.7 months, endothelial rejection developed in 6 and 2 eyes in the CsA and control groups, respectively. No differences were observed in the rates of graft clarity loss between the 2 groups (P = .16, Kaplan-Meier analysis).
  
  
  CONCLUSIONS
  No positive effect of systemic CsA administration for suppressing rejection in high-risk corneal transplantation was observed. With a relatively high incidence of systemic side effects, the results suggest that this protocol should not be recommended for corneal transplant recipients, especially those of advanced age.
authors.affiliation: Department of Ophthalmology, Tokyo Dental College, Chiba, Japan. jun@eyebank.or.jp
authors.forename: Jun
authors.initials: J
authors.lastname: Shimazaki
authors.forename: Seika
authors.initials: S
authors.lastname: Den
authors.forename: Masahiro
authors.initials: M
authors.lastname: Omoto
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Satake
authors.forename: Shigeto
authors.initials: S
authors.lastname: Shimmura
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tsubota
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016039:Corneal Transplantation; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine