The Belgian Endothelial Surgical Transplant of the Cornea

Launched by UNIVERSITY HOSPITAL, ANTWERP · Jun 23, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two different surgical techniques for treating problems with the cornea, which is the clear front part of the eye. The two techniques being studied are called Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK). Both procedures aim to help patients with conditions like Fuchs' Endothelial Dystrophy and Bullous Keratopathy, which can cause vision problems due to damage to the inner layer of the cornea. The goal is to see which method provides better results for patients in terms of their vision and overall quality of life.

To participate in the trial, individuals must be over 18 years old and have specific eye conditions related to corneal endothelial dysfunction. They should also be able to read and understand the study information and commit to follow-up visits at 3, 6, and 12 months after surgery. Participants will receive detailed information about the study and will need to give their consent to take part. It's important for potential participants to know that this study is currently recruiting, and they should discuss with their doctor if they think they might be eligible to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Fuchs Endothelial Dystrophy (FED);
• • Bullous Keratopathy (BK);
• • Other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft;
• • Pseudophakic (post cataract surgery);
• • Patients over 18 with the capacity to read and to understand the study information and to give informed consent, as well as study quality of life questionnaires;
• • Patients willing and capable to attend the 3, 6, and 12-month follow-up appointments.
• Exclusion Criteria:
• • Inability to provide informed consent;
• • Patients unable to attend the proposed follow up;
• • Inclusion of the fellow eye in the study;
• • Complex surgery combined with multiple pathologies (i.e., glaucoma surgery);
• • Other contraindications to lamellar corneas surgery;
• • Patients who elect not to participate;
• • Patients under 18 years of age;
• • Patients that are currently pregnant or breastfeeding;
• • Phakic patients with no direct plan to perform cataract surgery.