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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fuchs' Dystrophy, Bullous Keratopathy

Intervention / Treatment
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* Drug: Prednisolone acetate
* Drug: Fluorometholone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluorometholone 0.1% Solution<br>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. | Drug: Fluorometholone<br>* 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.<br>|
| Active Comparator: Prednisolone acetate 1% Solution<br>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: Prednisolone acetate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Immunologic Graft Rejection Episodes |  | Within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Intraocular Pressure (IOP) Elevation | Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading. | one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DMEK, Rejection, Corticosteroid