Clinical Trial: Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty

Brief Summary: Graft rejection has traditionally been one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. The purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.

Detailed Summary:
Sponsor: Cornea Research Foundation of America

Current Primary Outcome: Intraocular Pressure [ Time Frame: from 1 to 12 months after transplant ]

Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.


Original Primary Outcome: Change from baseline intraocular pressure [ Time Frame: 1, 3, 6 and 12 months after transplant ]

Current Secondary Outcome: Immunologic Graft Rejection Episode [ Time Frame: within first year after cornea transplantation ]

Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.


Original Secondary Outcome: Immunologic Graft Rejection Episode [ Time Frame: within first year after cornea transplantation ]

Information By: Cornea Research Foundation of America

Dates:
Date Received: May 8, 2013
Date Started: March 2013
Date Completion:
Last Updated: April 29, 2015
Last Verified: April 2015