OPTIMISE — safer steroid plans after DMEK cornea transplant
Official title: Optimized Immunosuppression for Corneal Transplantation: A Multi-center Randomized Controlled Clinical Trial
Run by Maastricht University Medical Center · NCT05716945 · Data updated 2026-11-12
This study tests whether using a milder steroid eye drop plan or stopping steroids earlier after DMEK can still prevent graft rejection while reducing the risk of high eye pressure in adults receiving corneal transplants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 342 (estimated) |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 8 sites (Apeldoorn, Gelderland and 7 other locations) |
| Status | Recruiting |
| Started | July 29, 2024 |
| Main results expected | September 2028 |
| Study ends | March 2029 |
| Registry record updated | October 6, 2025 |
| Trial ID | NCT05716945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21 or older who are registered on the NOTR as candidates for DMEK and who can complete follow-up without contraindications to the study medications are the intended participants.
✕Probably not a fit
Patients with prior corneal grafts in the study eye, history of uveitis or herpes simplex, HLA-typed allografts, current pregnancy or lactation, or those on other systemic or local immunosuppressants are unlikely to qualify or benefit from the tested regimen changes.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
OPTIMISE is a phase 4 interventional trial enrolling adults listed for DMEK in the Netherlands to compare different postoperative steroid strategies (dexamethasone 0.1%, fluorometholone 0.1%, or stopping steroids). Participants will follow an assigned steroid regimen after their endothelial keratoplasty and attend scheduled follow-up visits to monitor graft health and intraocular pressure. The primary goal is to find an evidence-based, cost-effective regimen that prevents rejection but lowers steroid-induced side effects. Outcomes include rates of rejection, changes in intraocular pressure, and treatment-related complications.
Why it matters
Potential benefit: If successful, patients could have fewer steroid-related side effects such as raised intraocular pressure while maintaining low graft rejection rates.
How similar studies have gone: DMEK itself is well established with low rejection rates, but randomized evidence on milder or shorter steroid regimens after DMEK is limited, so this approach is not yet widely proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
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 -
Leiden Universitair Medisch Centrum
Leiden, South Holland, Netherlands Recruiting
Show 2 more locations
-
Universitair Medisch Centrum Groningen
Groningen, Provincie Groningen, Netherlands Not yet recruiting -
Universitair Medisch Centrum Utrecht
Utrecht, Utrecht, Netherlands Not yet recruiting
Study contacts
- Study coordinator: Yexin Ye, MD
- Email: yexin.ye@mumc.nl
- Phone: +31 43 387 5406
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.