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Completed

NCT Number: NCT01448213

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

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.

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Key information

Conditions

Fuchs' Dystrophy Behavior Bullous Keratopathy Corneal dystrophy, Fuchs' endothelial, 1 Rejection, Psychology Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Erlangen, Erlangen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The following are requirements for inclusion in the study:

  • Male or female patient, at least 18 years of age, who is a candidate for DMEK due to corneal endothelial dysfunction or who has undergone DMEK within the last 7 weeks
  • Patient is able and willing to administer eye drops.
  • Patient is able to comprehend and has signed the Informed Consent form.
  • Patient is likely to complete the entire one-year course of the study.
  • Patient has best corrected visual acuity (BCVA) of at least 20/200 in the fellow eye.
  • Corneal neovascularization will not be judged as an exclusion criteria for the study

Exclusion criteria

The following are exclusion criteria for patients in this study:

  • A patient with a previous failed graft in the study eye with a history of a prior rejection episode
  • A patient exhibiting any intraocular inflammation
  • A patient with a known sensitivity to any of the ingredients in the study medications
  • A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
  • A patient with abnormal eyelid function
  • A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis
  • A patient with the presence of any ocular disease that would interfere with the evaluation of the study treatment
  • A patient with a history of non-compliance with using prescribed medication
  • A patient who is concurrently involved in or participated in another clinical trial within 30 days prior to enrollment in this study.

Treatment and study plan

Prednisolone Acetate

Drug

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.

Fluorometholone

Drug

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.

Primary outcomes

  1. Number of Eyes With Immunologic Graft Rejection Episodes

    Time frame: Within 1 year

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Price Vision Group

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2011
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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