Comparing cataract surgery with a new corneal transplant technique for patients with cataracts and Fuchs dystrophy
European Prospective Multicentre Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)
This study is testing whether a new corneal transplant technique combined with cataract surgery can improve vision and quality of life for people with cataracts and Fuchs dystrophy compared to standard cataract surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Aarhus N, Central Jutland and 3 other locations) |
| Trial ID | NCT06425666 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with nuclear cataracts and Fuchs Endothelial Corneal Dystrophy.
Not a fit: Patients with significant ocular or systemic comorbidities affecting vision may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve visual outcomes and quality of life for patients with cataracts and Fuchs dystrophy.
How similar studies have performed: Other studies have shown promise with similar surgical approaches, but this specific combination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus N, Central Jutland and 3 other locations
- Department of Ophthalmology, Aarhus University Hospital — Aarhus N, Central Jutland, Denmark (Not_yet_recruiting)
- Klinik für Ophthalmologie des Universitätsklinikums Köln — Cologne, North Rhine-Westphalia, Germany (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 Cologne
- Study coordinator: Björn Bachmann, Prof.
- Email: bjoern.bachmann@uk-koeln.de
- Phone: 0049-221 478-87476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.