Optimized Immunosuppression for Corneal Transplantation: A Multi-center Randomized Controlled Clinical Trial

What this Trial Is About

Researchers are evaluating the best immunosuppressive treatment after Descemet Membrane Endothelial Keratoplasty (DMEK), a common corneal transplant procedure. The study aims to find a cost-effective regimen that prevents rejection while minimizing side effects, especially steroid-induced intraocular pressure (IOP) increases that can harm vision. This randomized, controlled trial involves adult patients receiving DMEK to address uncertainty about optimal steroid use during the first two years after surgery. Participants all undergo DMEK surgery and are randomly assigned to different steroid eye drop regimens over two years. In the first year, one group uses Dexamethasone 0.1% tapered over several months, while the other switches from Dexamethasone to Fluorometholone 0.1% with tapering. In the second year, half of the patients in each group continue Fluorometholone daily, and the other half stop steroid treatment. This two-step approach compares standard treatment with a modified regimen to reduce side effects. During the trial, participants are monitored for changes in intraocular pressure in the first year and endothelial cell loss in the second year. Researchers also assess graft rejection rates, patient-reported outcomes, and cost-effectiveness. Various eye imaging techniques and optical measurements are used to evaluate structural outcomes. The study lasts 24 months, with careful follow-up to gather detailed safety and efficacy data to guide future care after corneal transplantation.

The OPTIMISE Study