Actively Recruiting
Comparing Postoperative Eye Inflammation Treatments Using Topical NSAIDs and Steroids Versus Steroids Alone After Corneal Endothelial Transplant Surgeries DSAEK or DMEK
Led by Oslo University Hospital · Updated on 2022-12-01
300
Participants Needed
1
Research Sites
121 weeks
Total Duration
AI-Summary
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 mgml starting the day after surgery, while the other group receives both topical nepafenac an NSAID 3 mgml and dexamethasone 1 mgml 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.
CONDITIONS
Brief Title
DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
Research Team
O
Olav Kristianslund, MD PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here