Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)
Condition: Fuchs' Dystrophy; Bullous Keratopathy
MeSH terms: Fuchs' Endothelial Dystrophy
Intervention: Prednisolone acetate; Fluorometholone
Intervention description: 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.; 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.
Intervention MeSH terms: Fluorometholone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DMEK; Rejection; Corticosteroid

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.
    

Eligibility criteria:

        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.