The OPTIMISE Study

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Jan 30, 2023

Keywords

ClinConnect Summary

The OPTIMISE Study is a clinical trial designed to find the best way to prevent rejection of corneal transplants while minimizing side effects for patients who undergo a specific surgery called Descemet Membrane Endothelial Keratoplasty (DMEK). Every year, many people in the Netherlands receive corneal transplants, and while the DMEK technique has a low rejection rate, patients often have to use strong eye drops for a long time that can lead to increased pressure in the eye, which can harm vision. This study aims to see if a new treatment approach with a specific type of eye drop (Fluorometholone) can help reduce the need for long-term medication while still preventing rejection of the transplant.

To participate in the trial, individuals must be at least 21 years old and scheduled for DMEK surgery. Participants will be randomly assigned to two different treatment groups after their surgery, and they will be monitored for two years. The study will look at how well the different treatment plans work by measuring eye pressure and other important outcomes. This research is important not only for improving patient care but also for reducing healthcare costs associated with unnecessary treatments.

Gender

ALL

Eligibility 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
• • Previous corneal graft in the study eye
• • Known sensitivity or contraindication to the ingredients in the study medications
• • History of uveitis or herpetic keratitis
• • Human Leukocyte Antigen (HLA) typed allograft
• • Pregnancy (current and planned) or lactation
• • Use of other local or systemic immunosuppressive drugs