[Long-term results of FK 506 eye drops following corneal transplantation].
BACKGROUND
Immunological graft rejection is the main reason for graft failure following corneal transplantation despite the use of topical and systemic steroids. As steroids are associated with side effects, alternative therapeutic strategies are needed.


METHODS
In this clinical trial patients undergoing corneal transplantation have been prospectively randomised to receive either prednisolone acetate 1 % eye drops 5 x /day, tapering off by one drop every month (n = 20), or to receive FK 506 eye drops 3 x /day for six months (n = 20). Patients in both groups received additionally systemic steroids for three weeks (fluocortolon 1 mg/kg body weight). Primary endpoints were the number of immune reactions and the clear graft survival, the secondary endpoint was the number of side effects.


RESULTS
Three immune reactions in the steroid group and one immune reaction in the FK 506 group were seen within the follow-up time of three years. No irreversible graft rejections occurred in either group. Eight patients in the FK 506 group concluded the study early due to local side effects.


CONCLUSIONS
In this long-term follow-up the use of FK 506 eye drops following corneal transplantation resulted in a lower number of immune reactions when compared to topical steroids. With a change in the galenic formulation FK 506 might be a powerful therapeutic option for preventing immunological graft rejection.
Reis
A
A
Augenklinik der Universität Freiburg. reis@augenwerk.li
Mayweg
S
S
Birnbaum
F
F
Reinhard
T
T
D000368:Aged; D017024:Chemotherapy, Adjuvant; D016039:Corneal Transplantation / Q000009:adverse effects*; D005260:Female; D006084:Graft Rejection / Q000209:etiology* / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016559:Tacrolimus