Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT06425666
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06425666
Study Brief:
Protocol Section:
NCT06425666