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Phase 4
Age: 18Years +
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ID05072262

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

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