European Prospective Multicentre Trial Comparing Cataract Surgery with Triple-DMEK in Patients with Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- BCVA 22
研究概览
简要总结
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.
详细描述
After signing the informed consent, patients are screened for eligibility for the trial regarding in- and exclusion criteria.
Different tests will be performed like ocular examination including slit lamp examination, fundus examination, IOP measurement, BCVA, Pentacam imaging, and Macular-OCT, vital signs. In addition, women below age of 60 have to perform a urine pregnancy test. Once all inclusion criteria and none of the exclusion criteria are met, the patient will be enrolled into the trial and will receive a subject-ID.
The Baseline Visit can take place up to 7 days after enrolment of the subject into the clinical trial. At the Baseline Visit a photograph of the cornea in retroillumination will be taken (can be taken either at Screening & Enrolment Visit or at Baseline Visit) and uploaded into the eCRF for central grading by CORIC.
In addition, subjects have to complete vision related quality of life questionnaires and changes in relevant medical history/concomitant diseases as well as concomitant medications have to be documented.
Furthermore, a contrast sensitivity test and an optical quality test (if device available) will be peformed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
After screening and enrollement subjects will be randomly allocated to the trial groups (cataract surgery versus triple-DMEK, allocation rate 1:1)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 < 0,7 and > 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
排除标准
- •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 interventional 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
结局指标
主要结局
BCVA 22
时间窗: 22 weeks +/- 14 days after surgery
Best corrected visual acuity (BCVA) is messured with EDTRS-charts (transformed to logMAR)
次要结局
- Change in visual acuity (BCVA)(Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery)
- Contrast sensitivity(22 weeks +/- 14 days after initial surgery)
- Change in contrast sensitivity(22 weeks +/- 14 days after initial surgery)
- Optical quality measured by HD-analyzer(22 weeks +/- 14 days after initial surgery)
- Change in optical quality measured by HD-analyzer(22 weeks +/- 14 days after initial surgery)
- Change in Optical quality measured by HD-analyzer(22 weeks +/- 14 days after initial surgery)
- Refractive accuracy:spherical equivalent(22 weeks +/- 14 days after initial surgery)
- Corneal topography/ tomography parameters(22 weeks +/- 14 days after initial surgery)
- Change in corneal topography/tomography parameters(At baseline and 22 weeks +/- 14 days after initial surgery)
- Central corneal thickness (CCT)(At baseline and 22 weeks +/- 14 days after initial surgery)
- Change in central corneal thickness (CCT)(At baseline and 22 weeks +/- 14 days after initial surgery)
- Quality of life(22 weeks +/- 14 days after initial surgery)
- Change in quality of life(At baseline and at 22 weeks +/- 14 days after initial surgery)
- Change in central retinal thickness(At baseline and at 22 weeks +/- 14 days after initial surgery)
- Change in intraocular pressure (IOP)(At baseline and at 22 weeks +/- 14 days after initial surgery)
- Additional ocular surgeries(At baseline and at 22 weeks +/- 14 days after initial surgery)
- Endothelial decompensation with indication for endothelial keratoplasty (either planned or already performed)(22 weeks +/- 14 days after initial surgery)
- Cystoid macular edema(22 weeks +/- 14 days after initial surgery)
研究者
Björn Bachmann
Clinical Professor
University of Cologne