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โ† Trials
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The OPTIMISE Study

RecruitingPhase 4Ages 21 Years - anyAllMaastricht University Medical Center
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In plain words

What the trial is, and whether it could suit you

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-f

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \- Patients aged 21 years or older registered on the NOTR as candidates for DMEK corneal transplantation Exclusion Criteria: * Inability to complete follow up or comply with study procedures * The participant is vulnerable * Previous corneal graft in the study eye * Known sensitivity or contraindication to the ingredients in the study medications * History of uveitis * History of any herpes simplex infection * Human Leukocyte Antigen (HLA) typed allograft * Pregnancy (current and planned) or lactation * Use of other local or systemic immunosuppressive drugs
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What it tests

  • Fluorometholone 0.1% Oph Susp
  • Dexamethasone 0.1% ophthalmic suspension
  • Stop steroids
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Where

8 sites
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Maastricht Universitair Medisch Centrum+
Maastricht, Netherlands
Amsterdam Universitair Medisch Centrum
Amsterdam, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Leiden Universitair Medisch Centrum
Leiden, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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