Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK) (NCT01448213) | Clinical Trial Compass
CompletedPhase 2
Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)
United States, Germany264 participantsStarted 2011-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Eyes With Immunologic Graft Rejection Episodes