Corneal graft rejection Trials in Disease

Study on Dexamethasone and Fluorometholone for Patients Undergoing Corneal Transplantation

This trial is investigating the best approach to prevent complications after corneal transplantation, specifically for patients undergoing a procedure called Descemet's Membrane Endothelial Keratoplasty, or DMEK. This type of surgery replaces only the inner layer of the cornea with healthy donor tissue, making it less invasive than other types of corneal transplants.

What the trial is testing: The study compares two different corticosteroid eye drops – Dexamethasone and Fluorometholone – against a placebo. The main goal is to find a treatment approach that reduces the risk of two common complications: increased eye pressure and loss of the important cells that keep the transplanted cornea clear and healthy. Participants will use the assigned eye drops and be monitored for up to two years to see how well the transplant is working and whether any side effects develop.

Who can participate: This trial is open to adults aged 21 years or older who are registered candidates for DMEK corneal transplantation. Both men and women can join the study.

Who cannot participate: The trial excludes several groups of patients to ensure safety and accurate results. You cannot participate if you have had a different type of corneal transplant in the past, if you have uncontrolled high pressure inside your eye, or if you have severe eye infections or inflammation. Patients currently taking medications that suppress the immune system for other health conditions are also excluded. Those with a history of severe allergic reactions to the medications being tested, pregnant or breastfeeding women, and individuals with other serious health conditions that might affect the study results are not eligible.

The medication being tested: The trial uses immunosuppressive therapy, which involves medications that help reduce your immune system's activity. This is important because after a corneal transplant, your body might try to reject the new tissue. By carefully controlling the immune response with these eye drop medications, the treatment aims to protect the transplanted cornea and help it heal properly. The challenge is finding the right balance – enough immune suppression to prevent rejection, but not so much that it causes other problems like increased eye pressure or infections.

The study will monitor several aspects of your eye health throughout the trial, including how well you can see, the survival of the transplanted tissue without rejection, and your overall satisfaction with the treatment. Researchers will also evaluate the cost-effectiveness of the treatment approach. The trial is expected to conclude by August 2028.