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

NCT01448213 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2014-09-03

Study results available
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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.

Conditions

  • Fuchs' Dystrophy
  • Bullous Keratopathy

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Price Vision Group

    lead INDUSTRY

Principal Investigators

  • Francis W Price, MD · Price Vision Group

  • Friedrich Kruse, MD · University of Erlangen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01448213 on ClinicalTrials.gov