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Study identifier: NCT05716945 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

The OPTIMISE Study

Condition: Pseudophakic Bullous Keratopathy · Fuchs' Endothelial Dystrophy · Intraocular Pressure  ·  Sponsor: Maastricht University Medical Center

PhasePhase 4
Planned participants342
Who can joinAll sexes, 21 Years to no upper limit
Healthy volunteersNo

About this study

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.

Talk to the study team

Yexin Ye, MD  ·  +31 43 387 5406  ·  yexin.ye@mumc.nl

Always discuss trial participation with your own doctor first.

Locations (8)

Gelre ZiekenhuizenApeldoorn, Gelderland, NetherlandsRecruiting
Radboud Universitair Medisch CentrumNijmegen, Gelderland, NetherlandsRecruiting
Maastricht Universitair Medisch Centrum+Maastricht, Limburg, NetherlandsRecruiting
Amsterdam Universitair Medisch CentrumAmsterdam, North Holland, NetherlandsRecruiting
Deventer ZiekenhuisDeventer, Overijssel, NetherlandsRecruiting
Universitair Medisch Centrum GroningenGroningen, Provincie Groningen, NetherlandsNot Yet Recruiting
Leiden Universitair Medisch CentrumLeiden, South Holland, NetherlandsRecruiting
Universitair Medisch Centrum UtrechtUtrecht, Utrecht, NetherlandsNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT05716945