Clinical Trial: Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)

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

Official Title: Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty

Brief Summary: The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The investigators hope to determine if one is more effective at preventing rejection or if both are equally effective.

Detailed Summary: Graft rejection is one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used after transplant surgery. The steroid eye drop dosing regimen varies from surgeon to surgeon, because no studies have been done to determine the optimum dosing regimen.
Sponsor: Price Vision Group

Current Primary Outcome: Number of Eyes With Immunologic Graft Rejection Episodes [ Time Frame: Within 1 year ]

Original Primary Outcome: Incidence of immunologic graft rejection episodes [ Time Frame: Within 1 year ]

Current Secondary Outcome: Number of Eyes With Intraocular Pressure (IOP) Elevation [ Time Frame: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK ]

Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.


Original Secondary Outcome: Incidence of intraocular pressure (IOP) elevation [ Time Frame: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK ]

Information By: Price Vision Group

Dates:
Date Received: October 4, 2011
Date Started: October 2011
Date Completion:
Last Updated: August 22, 2014
Last Verified: August 2014