Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425666
• Other study ID #: Uni-Koeln-5135
• Secondary ID: ORG-100006227
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: University of Cologne
• Contact: Björn Bachmann, Prof.
• Phone: 0049-221 478-87476
• Email: bjoern.bachmann[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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, BSCVA, Pentacam imaging, contrast sensivity test and Macula-OCT, vital signs.

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.

If Screening and Baseline assessments cannot be performed on the same day, a Baseline Visit can take place up to 7 days after enrolment of the subject into the clinical trial. At the Baseline Visit different tests will be performed like a Fluorescein stain test. In addition, subjects have to complete vision related quality of life questionnaires.

After all investigations are completed, the subject will be randomised and distributed to the respective treatment groups.

Patients who are enroled in arm 1 undergo exclusively a cataract surgery, in the comparator therapy (arm 2) patients undergo triple-DMEK (cataract surgery and DMEK)

The post-operative Visit will take place 22 weeks ± 14 days after the surgical intervention where different test have to be performed.

The duration of the clinical trial for every individual subject will be up to 24 weeks.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Corneal Dystrophies, Hereditary
• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• Intervention group /arm 1 (Cataract surgery alone)
Cataract surgery (experimental intervention / arm 1) is performed using a small incision technique. The main incision will be localized between 11 and 12 o'clock and will have a width of 2.4 to 2.8 mm. A tunnel suture will only be placed if there is leakage from the incisions. A thin dispersive viscoelastic is applied to the endothelium for protection before phacoemulsification. A hydrophobic acrylic monofocal IOL will be implanted into the bag.
• Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK)
After cataract surgery DMEK is continued using the surgeon's standard technique for graft implantation and unfolding in triple-DMEK. In all cases the graft will be implanted using the same main incision as for IOL implantation. Once the DMEK graft is unrolled and attached to the posterior corneal stroma the complete anterior chamber will be filled with SF6 20%.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Cologne	ESCRS (European Society of Cataract and Refractive Surgeons), The Clinical Trials Centre Cologne

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands,  Spain, 

Outcome

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