Condition: Pseudophakic Bullous Keratopathy · Fuchs' Endothelial Dystrophy · Intraocular Pressure · Sponsor: Maastricht University Medical Center
Rationale: The cornea is the most transplanted tissue in the Netherlands, with more than 1,500 procedures performed each year. A minimally invasive technique called Descemet Membrane Endothelial Keratoplasty (DMEK) has become the preferred method in the past decade. The main advantage of DMEK over previous techniques is a low graft rejection rate (1-2% per year). Despite this, rejection prophylaxis after DMEK follows the same high potency regimen as previous techniques in the first year, and patients are burdened with indefinite immunosuppression. The current project, OPTIMISE, aims to establish an evidence-based, cost-effective regimen that effectively prevents rejection and minimizes side effects. Corticosteroid eye drops are the mainstay of ocular immunomodulatory therapy. Their main side effect is a steroid-induced increase in intraocular pressure (IOP). It manifests in about one-fourth of patients within the first year after surgery and can lead to irreversible optic nerve damage and vision loss. Patients with IOP elevation require additional medications and hospital visits resulting in reduced quality of life and increased costs. The optimal dosing regimen in the first year after DMEK and whether patients may safely stop steroids after one year remains unknown. As a result, protocols in the Netherlands vary considerably from surgeon to surgeon. Patients are potentially over-treated in the short and long-term, resulting in undue burden for the patient and increased cos…
This description comes directly from the study's public registry record.
Yexin Ye, MD · +31 43 387 5406 · yexin.ye@mumc.nl
Always discuss trial participation with your own doctor first.
| Gelre Ziekenhuizen | Apeldoorn, Gelderland, Netherlands | Recruiting |
| Radboud Universitair Medisch Centrum | Nijmegen, Gelderland, Netherlands | Recruiting |
| Maastricht Universitair Medisch Centrum+ | Maastricht, Limburg, Netherlands | Recruiting |
| Amsterdam Universitair Medisch Centrum | Amsterdam, North Holland, Netherlands | Recruiting |
| Deventer Ziekenhuis | Deventer, Overijssel, Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen | Groningen, Provincie Groningen, Netherlands | Not Yet Recruiting |
| Leiden Universitair Medisch Centrum | Leiden, South Holland, Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht | Utrecht, Utrecht, Netherlands | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05716945