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Compares treatment options for Cataract Surgery
Official title Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
ClinicalTrials.gov ID: NCT06425666
What this study is testing
- What it's testing
- The purpose of the study is to investigate whether there is a difference in BCVA in patients who receive one of the following two surgeries: intervention group (arm 1) cataract surgery alone and control group (arm 2) cataract surgery combined with removal of the diseased endothelial cells and the attached Descemet's membrane followed by transplantation of a healthy endothelial cell layer with attached Descemet's membrane ("triple-DMEK" group; comparator therapy). The secondary objectives are to compare the two surgical methods with regard to other visual functions and optical as well as morphological differences, to safety, to quality of life, and to safety.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with FECD and nuclear cataract in study eye
- Male and female patients ≥18 years of age
- Subject must be able to understand and read the national language.
- Written informed consent prior to any study-related procedures
- Nuclear opalescence (NO) grades 2 and 3 according to the lens opacities classification system III (LOCS III)
You likely can't join if
- Patients with ocular and/or systemic comorbidity affecting vision or clinically proven anterior and/or posterior segment disease other than FECD and...
- Iris synechiae, pupil diameter \<6 mm after dilatation, pseudoexfoliation syndrome, subluxated lens, previous history of ocular trauma/surgery or...
- Subjective diurnal changes in visual acuity with worse visual acuity in the morning
- Corneal (epithelial) edema visible at slit lamp examination
- Preoperative anterior chamber depth below 2 mm
- Participation in other treatment trials parallel or within the last 4 weeks
See the full eligibility criteria
- Patients with FECD and nuclear cataract in study eye
- Male and female patients ≥18 years of age
- Subject must be able to understand and read the national language.
- Written informed consent prior to any study-related procedures
- Nuclear opalescence (NO) grades 2 and 3 according to the lens opacities classification system III (LOCS III)
- 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)
- Central corneal thickness (CCT) measured with Pentacam below 620 µm between 8:00 am and 01:00 pm
- BCVA logMAR \ 0,1
- No previous cataract surgery or triple-DMEK on the opposite side
- Pentacam quality specification: "OK"
- For women below age of 60 negative urine pregnancy test
- 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)
- Iris synechiae, pupil diameter \<6 mm after dilatation, pseudoexfoliation syndrome, subluxated lens, previous history of ocular trauma/surgery or inflammatory disease
- Subjective diurnal changes in visual acuity with worse visual acuity in the morning
- Corneal (epithelial) edema visible at slit lamp examination
- Preoperative anterior chamber depth below 2 mm
- Participation in other treatment trials parallel or within the last 4 weeks
- Systemic use of Alpha-1-Adrenozeptor-Antagonists, immunosuppressive therapy or chemotherapy
- Pregnant women and nursing mothers
- Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator
- Legally incapacitated persons
- Persons held in an institution by legal or official order
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Central Jutland, Denmark
- Cologne, North Rhine-Westphalia, Germany
- Nijmegen, Gelderland, Netherlands
- Barcelona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Central Jutland, Denmark; Cologne, North Rhine-Westphalia, Germany; Nijmegen, Gelderland, Netherlands; Barcelona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.