Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

Launched by UNIVERSITY OF COLOGNE · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring two different types of surgery for patients who have both cataracts and a condition called Fuchs Endothelial Corneal Dystrophy (FECD). The trial aims to see if there is a difference in vision improvement between patients who have cataract surgery alone and those who have a more complex procedure called "triple-DMEK," where unhealthy cells in the cornea are removed and replaced with healthy cells. The study will also look at other aspects like safety, quality of life, and overall eye health after the surgeries.

To participate in this trial, you need to be at least 18 years old and have FECD along with a nuclear cataract in one eye. You should be able to read and understand the local language and provide written consent. Participants will undergo evaluations to ensure they meet specific eye health criteria. If you join the study, you can expect to receive either of the two surgeries and have your vision and eye health monitored closely afterward. This trial is currently recruiting participants, and it’s important to note that some individuals, like those with certain eye conditions or who are pregnant, may not be eligible to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with FECD and nuclear cataract in study eye
• • 2. Male and female patients ≥18 years of age
• • 3. Subject must be able to understand and read the national language.
• • 4. Written informed consent prior to any study-related procedures
• • 5. Nuclear opalescence (NO) grades 2 and 3 according to the lens opacities classification system III (LOCS III)
• • 6. Krachmer grade (3 \[2-5 mm diameter area with confluent guttae\]; 4 \[ \> 5 mm diameter area with confluent guttae\] without edema identified by slit lamp examination)
• • 7. Central corneal thickness (CCT) measured with Pentacam below 620 µm between 8:00 am and 01:00 pm
• • 8. BCVA logMAR \< 0,7 and \> 0,1
• • 9. No previous cataract surgery or triple-DMEK on the opposite side
• • 10. Pentacam quality specification: "OK"
• • 11. For women below age of 60 negative urine pregnancy test
• Exclusion Criteria:
• • 1. Patients with ocular and/or systemic comorbidity affecting vision or clinically proven anterior and/or posterior segment disease other than FECD and cataract (exclusion of macular disease or edema by OCT)
• • 2. Iris synechiae, pupil diameter \<6 mm after dilatation, pseudoexfoliation syndrome, subluxated lens, previous history of ocular trauma/surgery or inflammatory disease
• • 3. Subjective diurnal changes in visual acuity with worse visual acuity in the morning
• • 4. Corneal (epithelial) edema visible at slit lamp examination
• • 5. Preoperative anterior chamber depth below 2 mm
• • 6. Participation in other interventional trials parallel or within the last 4 weeks
• • 7. Systemic use of Alpha-1-Adrenozeptor-Antagonists, immunosuppressive therapy or chemotherapy
• • 8. Pregnant women and nursing mothers
• • 9. Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator
• • 10. Legally incapacitated persons
• • 11. Persons held in an institution by legal or official order