Cataract Surgery Clinical Trial
Official title:
European Prospective Multicentre, Open Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)
The purpose of this study is to investigate whether there is a difference in best spectacle corrected visual acuity (BSCVA) in patients treated with one of the following two surgeries: (1) cataract surgery with preservation of the diseased endothelial cells ("cataract surgery only experimental intervention, investigational therapy/ arm 1); (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"(""cataract surgery only", control intervention comparator therapy/ arm 2)
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | June 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. BSCVA 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Ophthalmology, Aarhus University Hospital | Aarhus N | Midtjylland |
Germany | Klinik für Ophthalmologie des Universitätsklinikums Köln | Köln | NRW |
Netherlands | Radboud-Universität Nijmegen | Nijmegen | Gelderland |
Spain | Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University of Cologne | ESCRS (European Society of Cataract and Refractive Surgeons), The Clinical Trials Centre Cologne |
Denmark, Germany, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of the study is to investigate whether there is a difference in best spectacle corrected visual acuity (BSCVA) in patients who receive one of the following two surgeries: (arm 1) cataract surgery alone and (arm 2) triple-DMEK | Best spectacle corrected visual acuity (BSCVA) is messured with EDTRS-charts (transformed to logMAR) | 22 weeks +/- 14 days after surgery | |
Secondary | Change in visual acuity (BSCVA) | Specific measurement variable: ETDRS charts (transformed to logMAR); Analysis metric (participant level): Difference BSCVA at follow-up - BSCVA at baseline [logMAR - no dimension]; Method of aggregation (summary measure for each study group): Mean difference | Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery | |
Secondary | Contrast sensitivity | Specific measurement variable: Total score of Freiburg Vision Test "FrACT"; Analysis metric (participant level): Value [logCS (Weber)]; Method of aggregation (summary measure for each study group): Mean | 22 weeks +/- 14 days after initial surgery | |
Secondary | Optical quality measured by HD-analyzer | Specific measurement variable: Total score of objective scattering index (OSI); Analysis metric (participant level): Value [OSI - no dimension]; Method of aggregation (summary measure for each study group): Mean | 22 weeks +/- 14 days after initial surgery | |
Secondary | Optical quality measured by HD-analyzer | Specific measurement variable: Total score of Modulation transfer function (MTF) cut-off; Analysis metric (participant level): Value [c/deg]; Method of aggregation (summary measure for each study group): Mean | 22 weeks +/- 14 days after initial surgery | |
Secondary | Optical quality measured by HD-analyzer | Specific measurement variable: Total score of Strehl ratio; Analysis metric (participant level): Value [no dimension]; Method of aggregation (summary measure for each study group): Mean | 22 weeks +/- 14 days after initial surgery | |
Secondary | Refractive accuracy:spherical equivalent | Specific measurement variable: Deviation from target refraction [D], mean error [ME], mean absolute error [MAE]; Analysis metric (participant level): Value (D, ME and/or MAE) [D]); Method of aggregation (summary measure for each study group): Mean | 22 weeks +/- 14 days after initial surgery | |
Secondary | Corneal topography/ tomography | Specific measurement variable: Corneal densitometr (grayscale unit GSU) (Anterior, central, posterior and total layer); Analysis metric (participant level): Value [GSU]; Method of aggregation (summary measure for each study group): Mean | 22 weeks +/- 14 days after initial surgery | |
Secondary | Change in Corneal topography/tomography parameters | Specific measurement variable: Corneal densitometry (grayscale unit GSU) (Anterior, central, posterior and total layer); Analysis metric (participant level): Difference value at follow-up - baseline value [GSU]; Method of aggregation (summary measure for each study group): Mean difference | At baseline and 22 weeks +/- 14 days after initial surgery | |
Secondary | Change in central corneal thickness (CCT) | Specific measurement variable: CCT measured by Pentacam [µm]; Analysis metric (participant level): Difference CCT at follow up - CCT baseline [µm]; Method of aggregation (summary measure for each study group): Mean difference | At baseline and 22 weeks +/- 14 days after initial surgery | |
Secondary | Cystoid macular edema | Specific measurement variable: CME visualized by SD-OCT; Analysis metric (participant level): Value [yes/no]; Method of aggregation (summary measure for each study group): Proportion | 22 weeks +/- 14 days after initial surgery | |
Secondary | Change in central retinal thickness | Specific measurement variable: Measured by SD-OCT; Analysis metric (participant level): Difference value at follow-up - baseline value [µm]; Method of aggregation (summary measure for each study group): Mean | At baseline and at 22 weeks +/- 14 days after initial surgery | |
Secondary | Quality of life after surgery | Specific measurement variable: Catquest-9SF (all centers) and V-Fuchs (Germany only); Analysis metric (participant level): Total score [no dimension]; Method of aggregation (summary measure for each study group): Mean | 22 weeks +/- 14 days after initial surgery | |
Secondary | Change in quality of life | Specific measurement variable: Catquest-9SF (all centers) and V-Fuchs (Germany only); Analysis metric (participant level): Difference in total score [no dimension] (follow-up-- baseline) [no dimension]; Method of aggregation (summary measure for each study group): Mean | At baseline and at 22 weeks +/- 14 days after initial surgery | |
Secondary | Change in intraocular pressure (IOP) from baseline | Analysis metric (participant level): Value [mmHg] | At baseline and at 22 weeks +/- 14 days after initial surgery | |
Secondary | Postoperative endothelial decompensation | Analysis metric (participant level): Value [yes/no] | 22 weeks +/- 14 days after initial surgery | |
Secondary | Additional ocular surgeries | Analysis metric (participant level): Value [yes/no] | 22 weeks +/- 14 days after initial surgery |
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