A Randomized Trial Comparing Postoperative Topical NSAIDs and Steroids to Steroids Alone in Patients Undergoing Corneal Endothelial Transplantations (DMEC)

What this Trial Is About

Researchers are evaluating the effects of two medication regimens on inflammation and cystoid macular edema in patients undergoing corneal endothelial transplantations, specifically Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) or Descemet Membrane Endothelial Keratoplasty (DMEK). This randomized clinical trial compares using postoperative topical nonsteroidal anti-inflammatory drugs (NSAIDs) combined with steroids to using only postoperative topical steroids. The trial is sponsored by Oslo University Hospital and is a Phase 4 study. Participants are randomly assigned to one of two groups: one group receives topical dexamethasone 1 mg/ml starting the day after surgery, while the other group receives both topical nepafenac (an NSAID) 3 mg/ml and dexamethasone 1 mg/ml starting the day after surgery. These medications are applied postoperatively to assess their effects on eye inflammation and macular edema following surgery. During the study, participants undergo multiple assessments including measurements of central macular thickness and cystoid macular edema at 4 weeks after surgery as the primary outcomes. Secondary outcomes include evaluations of intraocular inflammation, intraocular pressure, visual outcomes, corneal endothelial status, and patient-reported outcomes at various timepoints up to two years post-surgery. The study involves preoperative and postoperative examinations to monitor these outcomes and ensure participant safety throughout the follow-up period.

DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)