The Belgian Endothelial Surgical Transplant of the Cornea (BESTCornea)

The Belgian Endothelial Surgical Transplant of the Cornea:Clinical and Patient-reported Outcomes of Descemet Stripping Automated Endothelial Keratoplasty(DSAEK) Versus Descemet Membrane Endothelial Keratoplasty(DMEK)

This study is designed as a randomised multicentric parallel group pragmatic trial of Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) in corneal endothelial decompensation. the purpose is to compare the clinical and patient reported outcomes of both therapies across a broad range of indications.

Study Overview

• Status: Recruiting
• Conditions: Corneal Edema; Fuchs' Endothelial Dystrophy; Bullous Keratopathy; Pseudophakic Bullous Keratopathy; Corneal Endothelial Disorder
• Intervention / Treatment: Procedure: DSAEK; Procedure: DMEK

Detailed Description

The current problem concerns variability in the provision of corneal endothelial keratoplasties available to patients in Belgium. Some patients receive DSAEK and some (albeit fewer) receive DMEK. Currently the type of corneal graft that a patient receives depends on the treating surgeon opinions.

In this study 220 patients in 11 surgical centres will be recruited and allocated to one of the two surgical options. Both the Ultrathin DSAEK and DMEK grafts will be prepared by corneal banks in the University Hospital of Liege and University Hospital of Antwerp respectively. Patients will be examined preoperatively and postoperatively at 3, 6 and 12 months. Clinical information such as best-corrected visual acuity and refraction will be collected as well as quality of life information based on the EQ-5D-5L and the VFQ 25 assessment tools. These data be used to compare the interventions both on the clinical level as well as from the patient perspective.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veerle Van Gerwen, BSc; Phone Number: 5271 +3238210000; Email: bestcornea@uza.be
• Study Contact Backup: Name: Ann Deconinck, BSc; Phone Number: 2466 +3238210000; Email: bestcornea@uza.be

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • AZ Imelda
    • Contact: Leslie Deroy; Email: leslie.deroy@imelda.be
    • Principal Investigator: Karolien Termote, MD
  • Brussel, Belgium
    • Recruiting
    • UZ Brussel
    • Principal Investigator: Karolien Termote, MD
    • Contact: Bert Verhelst; Email: bert.verhelst@uzbrussel.be
    • Sub-Investigator: Sorcha Ni Dhubhghaill, PhD
  • Brussel, Belgium
    • Recruiting
    • Erasmus ziekenhuis Brussel
    • Principal Investigator: Marc Schrooyen, PhD
    • Sub-Investigator: Pauline Le Roux, MD
    • Contact: Pauline Le Roux; Email: pauline.leroux@hubruxelles.be
  • Deurne, Belgium
    • Recruiting
    • AZ Monica (campus Deurne)
    • Contact: Caroline Lamoen; Email: caroline.lamoen@azmonica.be
    • Principal Investigator: Isabel Bleyen, MD
  • Genk, Belgium
    • Recruiting
    • Ziekenhuis Oost-Limburg (ZOL)
    • Contact: Frauke Somers; Email: frauke.somers@zol.be
    • Principal Investigator: Sacha Gast, MD
  • Gent, Belgium
    • Recruiting
    • UZ Gent
    • Contact: Julie Sambaer; Email: octu@uzgent.be
    • Principal Investigator: Dimitri Roels, MD
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Principal Investigator: Heleen Delbeke, PhD
    • Sub-Investigator: Isabelle Saelens, PhD
    • Contact: Martine Spaas; Email: martine.spaas@uzleuven.be
  • Liège, Belgium
    • Recruiting
    • CHU Liege
    • Contact: Séverine Camby; Email: s.camby@chuliege.be
    • Principal Investigator: Bernard Duchense, PhD
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Contact: veerle Van Gerwen, BSc; Email: veerle.vangerwen@uza.be
      • Principal Investigator: Carina Koppen, PhD
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium
      • Recruiting
      • AZ Maria Middelares
      • Contact: Ilse Claerhout, PhD; Email: Ilse.Claerhout@azmmsj.be
      • Principal Investigator: Ilse Claerhout, PhD
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium
      • Recruiting
      • AZ Sint-Jan Brugge
      • Contact: Liesbeth Laloo; Email: Liesbeth.Laloo@azsintjan.be
      • Principal Investigator: Sophie De Craene, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fuchs Endothelial Dystrophy (FED);
• Bullous Keratopathy (BK);
• Other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft;
• Pseudophakic (post cataract surgery);
• Patients over 18 with the capacity to read and to understand the study information and to give informed consent, as well as study quality of life questionnaires;
• Patients willing and capable to attend the 3, 6, and 12-month follow-up appointments.

Exclusion Criteria:

• Inability to provide informed consent;
• Patients unable to attend the proposed follow up;
• Inclusion of the fellow eye in the study;
• Complex surgery combined with multiple pathologies (i.e., glaucoma surgery);
• Other contraindications to lamellar corneas surgery;
• Patients who elect not to participate;
• Patients under 18 years of age;
• Patients that are currently pregnant or breastfeeding;
• Phakic patients with no direct plan to perform cataract surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: UT-DSAEK; Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty refers to the use of a corneal endothelial/Descemet graft with a thin layer of stroma (<110um) attached.	Procedure: DSAEK; The main incision (3.5-5mm) is created at the corneal limbus or via a cornea-scleral tunnel with 2-3 smaller (approx. 1mm) paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber, according to the surgeon's preference. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed. Once the anterior chamber is prepared, OVD or air has been removed, then the eye is ready for the new corneal graft. The pre-cut corneal tissue delivered by the bank is then gently rinsed and may be stained with 0.06% trypan blue if required. The tissue is loaded into a glide or injector, and pulled into the anterior chamber using a smooth-tipped micro-forceps (e.g., Busin forceps). Once the graft enters the eye, it is lifted to the posterior cornea. The graft is further centred using air (or SF6 Gas) in the anterior chamber.; Other Names: Descemet Stripping Automated Endothelial Keratoplasty
Active Comparator: DMEK; Descemet membrane endothelial keratoplasty refers to the use of a corneal endothelial/Descemet graft with no layer of associated stroma (15-20um thick)	Procedure: DMEK; The main incision (2.8-3mm) is created superior or temporally at the corneal limbus and is accompanied by 2-3 smaller paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed. The DMEK roll is poured into a basin and rinsed. The graft is then stained with 0.06% trypan blue to aid in graft visualization. The graft is loaded into an injector and introduced into the anterior chamber. The graft is unrolled using external manoeuvres and once unrolled, it is lifted to the back of the cornea. The eye is then pressurised with a full air fill from 10 to 120 minutes. The pressure is then reduced and the case is completed by suturing any incisions required.; Other Names: Descemet Membrane Endothelial Keratoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA 12m	Best-corrected visual acuity expressed in LogMAR	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA 3 and 6m	Best-corrected visual acuity expressed in LogMAR	3 and 6 months
UCVA 3,6 and12m	Uncorrected visual acuity expressed in LogMAR	3, 6 and 12 months
Change in refraction	Change in objective refraction - spectacle correction	3, 6 and 12 months
Proportion of high vision	Proportion of patients to achieve 0.2 LogMAR visual acuity or less	12 months
EQ-5D-5L	Quality of life measured by the fifth level EuroQol (EQ-5L) instrument where five dimensions are scored at 5 levels - the higher the level, the worse the health state. The digits for the five dimensions can be combined to a 5-digit number to describe the patient's health state	3, 6 and 12 months
VFQ 25	Vision related quality of life measured by the Visual Function Questionnaire(VFQ-25) scored on a scale of 0-100, with a higher score reporesenting higher quality of vision related quality of life.	3, 6 and 12 months
ECC	Endothelial cell count	3, 6 and 12 months
CCT	Central corneal thickness	3, 6 and 12 months
Complications	Complications associated with the intervention	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Belgium Health Care Knowledge Centre
• Investigators: Study Chair: Carina Koppen, MD, PhD, University Hospital, Antwerp; Study Chair: Bernard Duchesne, MD, PhD, University Hospital Liege; Study Director: Sorcha Ni Dhubhghaill, MBBCh, PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: DMEK; DSAEK; UT-DSAEK
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Corneal Edema; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: UZAntwerpen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data sharing of the final trial dataset will be offered in the following manner:

The Chief Investigator, Trial Steering Committee, and the Sponsor (including data monitors) will have access to the trial dataset, but a site's Prinicpal Investigator may submit a request for data access.

This will be discussed and approved by the Trial Steering Committee. Upon conclusion of the trial, individual participant data that underlie the results reported in the article (after deidentification) will be shared upon the request of any relevant interested party.

Access to the final trial dataset by other parties: reasonable requests for access to trial data from other parties will be considered and approved in writing where appropriate, following formal application to the Trial Steering Committee (bestcornea@uza.be).

• IPD Sharing Time Frame: The article with regards to the study protocol is now under revision in an open acces medical journal.
• IPD Sharing Access Criteria: The article with regards to the study protocol will be published in an open access medical journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No