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

Phase 2

Completed

• Conditions: Bullous Keratopathy; Fuchs' Dystrophy
• Interventions: Drug: Fluorometholone; Drug: Prednisolone acetate

• Registration Number: NCT01448213
• Lead Sponsor: Price Vision Group

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 Description

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-07
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-08
• Results First Submitted: 2014-08-04
• Results First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-22
• Results First Posted: 2014-08-25
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluorometholone 0.1% Solution	Fluorometholone	Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Prednisolone acetate 1% Solution	Prednisolone acetate	Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Primary Outcome Measures

Name	Time	Method
Number of Eyes With Immunologic Graft Rejection Episodes	Within 1 year

Secondary Outcome Measures

Name	Time	Method
Number of Eyes With Intraocular Pressure (IOP) Elevation	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.

Trial Locations

Locations (2)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

University of Erlangen; 🇩🇪 Erlangen, Germany