JAN 16, 2009
This prospective randomized study found that topical cyclosporine 0.05% combined with topical dexamethasone was not better than topical dexamethasone alone at preventing graft rejection following high-risk keratoplasty.
The authors randomly assigned 25 high-risk keratoplasty patients older than age 21 to treatment with one drop of topical cyclosporine 0.05% (Restasis, Allergan, Inc., Irvine, Calif.) four times daily and topical dexamethasone 0.1% six times daily, and 22 high-risk keratoplasty patients to only the dexamethasone regimen. They defined high risk as having corneal vessels(diagnosed by their presence in two or more quadrants, deep stromal vascularization or extension to graft-host junction), history of graft rejection in the same eye, previous history of herpetic eye disease, dry eye or previous ocular inflammation, infection or chemical injury.
All treatment was started on the first postoperative day, and surgery was performed by the study's authors. The combination treatment patients were followed for an average of 20.2 months and the dexamethasone-only group for 18.5 months, which was not significantly different.
The authors found that the mean duration of immunosuppression was 9.5 months in the combination treatment group and 10.8 months in the dexamethasone-only group. The rejection-free graft survival rate was 60.8 percent in the combination group and 54.5 percent in the monotreatment group, while the graft survival rate was 73.9 percent and 68.1 percent, respectively. None of these results were significantly different between the groups.
The authors speculated that higher cyclosporine concentrations might be more effective at preventing corneal graft rejection in high-risk patients than the commercially available topical cyclosporine 0.05% used in the study.