Comparing cataract surgery with a new corneal transplant technique for patients with cataracts and Fuchs dystrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of two surgical approaches for patients suffering from cataracts and Fuchs Endothelial Corneal Dystrophy. Participants will be randomly assigned to either receive standard cataract surgery or a combined procedure that includes cataract surgery and a novel triple-DMEK corneal transplant. The study aims to assess differences in best-corrected visual acuity (BCVA), safety, quality of life, and other visual functions between the two groups. Comprehensive ocular examinations and quality of life questionnaires will be utilized to gather data on patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Klinik für Ophthalmologie des Universitätsklinikums Köln
  Cologne, North Rhine-Westphalia, Germany Recruiting
• Department of Ophthalmology, Aarhus University Hospital
  Aarhus N, Central Jutland, Denmark Not yet recruiting
• Radboud-Universität Nijmegen
  Nijmegen, Gelderland, Netherlands Not yet recruiting
• Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva
  Barcelona, Barcelona, Spain Not yet recruiting

Study contacts

• Principal investigator: Björn Bachmann, Prof. — University Hospital of Cologne
• Study coordinator: Björn Bachmann, Prof.
• Email: bjoern.bachmann@uk-koeln.de
• Phone: 0049-221 478-87476

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.