## Protocol Section
### Identification Module
**NCT ID:** NCT06425666

**Brief Title:** Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

**Official Title:** European Prospective Multicentre, Open Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial)

#### Organization Study ID Info
**ID:** Uni-Koeln-5135
#### Organization
**Class:** OTHER
**Full Name:** University of Cologne
#### Secondary ID Infos
**Domain:** ESCRS (European society of Cataract and Refractive Surgeons)
**ID:** ORG-100006227
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** The Clinical Trials Centre Cologne

**Class:** UNKNOWN

**Name:** ESCRS (European Society of Cataract and Refractive Surgeons)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Cologne

#### Responsible Party

**Investigator Affiliation:** University of Cologne

**Investigator Full Name:** Björn Bachmann

**Investigator Title:** Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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)

**Detailed 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.

### Conditions Module

**Conditions:**

- Cataract Surgery

- Cataract and Fuchs Endothelial Corneal Dystrophy

**Keywords:**

- Fuchs´ Endothelial Corneal Dystrophy Krachmer grade 3 and 4

- nuclear cataract

- Nuclear opalescence (NO) grades 2

- Nuclear opalescence (NO) grades 3

- Central corneal thickness

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Masking Description:** After screening and enrollement subjects will be randomly allocated to the trial groups (cataract surgery versus triple-DMEK, allocation rate 1:1)

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** After randomisation the investigational therapy (arm 1), patients undergo a cataract surgery (cataract surgery with preservation of the diseased endothelial cells). The cataract surgery will take approximately 10-20 minutes.

The follow-up period after surgery will be 22 weeks ± 14 days.

**Intervention Names:**

- Procedure: Intervention group /arm 1 (Cataract surgery alone)

**Label:** Experimental intervention /arm 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** After randomisation, patients in the comparator therapy (arm 2) undergo triple-DMEK which is a cataract surgery combined with DMEK (removal of the diseased endothelial cells followed by transplantation of a healthy endothelial cell layer).

Triple-DMEK takes approximately 5-10 minutes longer than cataract surgery. The follow-up period after surgery will be 22 weeks ± 14 days.

**Intervention Names:**

- Procedure: Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK)

**Label:** Control intervention /arm2

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental intervention /arm 1

**Description:** 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.

**Name:** Intervention group /arm 1 (Cataract surgery alone)

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Control intervention /arm2

**Description:** 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%.

**Name:** Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK)

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Best spectacle corrected visual acuity (BSCVA) is messured with EDTRS-charts (transformed to logMAR)

**Measure:** 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

**Time Frame:** 22 weeks +/- 14 days after surgery

#### Secondary Outcomes

**Description:** 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

**Measure:** Change in visual acuity (BSCVA)

**Time Frame:** Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Contrast sensitivity

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Optical quality measured by HD-analyzer

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Optical quality measured by HD-analyzer

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Optical quality measured by HD-analyzer

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Refractive accuracy:spherical equivalent

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Corneal topography/ tomography

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Change in Corneal topography/tomography parameters

**Time Frame:** At baseline and 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Change in central corneal thickness (CCT)

**Time Frame:** At baseline and 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Cystoid macular edema

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Change in central retinal thickness

**Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Quality of life after surgery

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** 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

**Measure:** Change in quality of life

**Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery

**Description:** Analysis metric (participant level): Value \[mmHg\]

**Measure:** Change in intraocular pressure (IOP) from baseline

**Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery

**Description:** Analysis metric (participant level): Value \[yes/no\]

**Measure:** Postoperative endothelial decompensation

**Time Frame:** 22 weeks +/- 14 days after initial surgery

**Description:** Analysis metric (participant level): Value \[yes/no\]

**Measure:** Additional ocular surgeries

**Time Frame:** 22 weeks +/- 14 days after initial surgery

### Eligibility Module

**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. 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bjoern.bachmann@uk-koeln.de

**Name:** Björn Bachmann, Prof.

**Phone:** 0049-221 478-87476

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aarhus N

**Contacts:**

***Contact 1:***

- **Email:** jesper.hjortdal@clin.au.dk

- **Name:** Jesper Hjortdal, Prof.

- **Phone:** 78 45 46 44, 23346770

- **Phone Ext:** 0045

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jesper Hjortdal, Prof.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Department of Ophthalmology, Aarhus University Hospital

**State:** Midtjylland

**Zip:** DK- 8200

**Location 2:**

**City:** Köln

**Contacts:**

***Contact 1:***

- **Email:** bjoern.bachmann@uk-koeln.de

- **Name:** Björn Bachmann, Prof.

- **Phone:** 0049-2214784308

- **Role:** CONTACT

***Contact 2:***

- **Name:** Björn Bachmann, Prof.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Germany

**Facility:** Klinik für Ophthalmologie des Universitätsklinikums Köln

**State:** NRW

**Zip:** 50937

**Location 3:**

**City:** Nijmegen

**Contacts:**

***Contact 1:***

- **Email:** Siamak.Nobacht@radboudumc.nl

- **Name:** Siamak Nobacht, Dr.

- **Phone:** 653613048

- **Phone Ext:** 0031

- **Role:** CONTACT

***Contact 2:***

- **Name:** Siamak Nobacht, Dr.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Netherlands

**Facility:** Radboud-Universität Nijmegen

**State:** Gelderland

**Zip:** GA 6525

**Location 4:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Email:** Jose.guell@imo.es

- **Name:** José Luis Güell, Dr.

- **Phone:** 934 000 700

- **Phone Ext:** 0034

- **Role:** CONTACT

***Contact 2:***

- **Name:** José Luis Güell, Dr.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva

**Zip:** 08035

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital Cologne

**Name:** Björn Bachmann, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007905

- Term: Lens Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000003316

- Term: Corneal Diseases

- ID: D000015785

- Term: Eye Diseases, Hereditary

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M5638

- Name: Cataract

- Relevance: HIGH

- As Found: Cataract

- ID: M6540

- Name: Corneal Dystrophies, Hereditary

- Relevance: HIGH

- As Found: Corneal Dystrophy

- ID: M8761

- Name: Fuchs' Endothelial Dystrophy

- Relevance: HIGH

- As Found: Fuchs Endothelial Corneal Dystrophy

- ID: M10917

- Name: Lens Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6539

- Name: Corneal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18339

- Name: Eye Diseases, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002386

- Term: Cataract

- ID: D000003317

- Term: Corneal Dystrophies, Hereditary

- ID: D000005642

- Term: Fuchs' Endothelial Dystrophy

### Misc Info Module

- Version Holder: 2024-05-31
