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The Belgian Endothelial Surgical Transplant of the Cornea (BESTCornea)

Primary Purpose

Corneal Edema, Corneal Endothelial Disorder, Fuchs' Endothelial Dystrophy

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
DSAEK
DMEK
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Edema focused on measuring DMEK, DSAEK, UT-DSAEK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Antwerp University HospitalRecruiting
  • AZ Maria MiddelaresRecruiting
  • AZ Sint-Jan BruggeRecruiting
  • AZ ImeldaRecruiting
  • Erasmus ziekenhuis Brussel
  • UZ BrusselRecruiting
  • AZ Monica (campus Deurne)Recruiting
  • Ziekenhuis Oost-Limburg (ZOL)Recruiting
  • UZ GentRecruiting
  • UZ LeuvenRecruiting
  • CHU LiègeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

UT-DSAEK

DMEK

Arm Description

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.

Descemet membrane endothelial keratoplasty refers to the use of a corneal endothelial/Descemet graft with no layer of associated stroma (15-20um thick)

Outcomes

Primary Outcome Measures

BCVA 12m
Best-corrected visual acuity expressed in LogMAR

Secondary Outcome Measures

BCVA 3 and 6m
Best-corrected visual acuity expressed in LogMAR
UCVA 3,6 and12m
Uncorrected visual acuity expressed in LogMAR
Change in refraction
Change in objective refraction - spectacle correction
Proportion of high vision
Proportion of patients to achieve 0.2 LogMAR visual acuity or less
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
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.
ECC
Endothelial cell count
CCT
Central corneal thickness
Complications
Complications associated with the intervention

Full Information

First Posted
June 23, 2022
Last Updated
August 3, 2023
Sponsor
University Hospital, Antwerp
Collaborators
Belgium Health Care Knowledge Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05436665
Brief Title
The Belgian Endothelial Surgical Transplant of the Cornea
Acronym
BESTCornea
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Belgium Health Care Knowledge Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema, Corneal Endothelial Disorder, Fuchs' Endothelial Dystrophy, Bullous Keratopathy, Pseudophakic Bullous Keratopathy
Keywords
DMEK, DSAEK, UT-DSAEK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After the patient has been screened and deemed eligible for participation, and the informed consent of the patient has been obtained, the patients will be included in the study. Once the inclusion data is entered by a member of the study personnel into the trial software, allocation of the patient to a treatment arm will take place using minimisation. The allocation will be performed with an equal 1:1 allocation to DSAEK or DMEK with minimisation using the following stratification of participant factors: Surgical Indication (i.e., Fuchs' endothelial dystrophy and non Fuch's endothelial dystrophy); Surgical site; Preoperative visual acuity (Patients with 0.6 LogMAR BCVA or lower (i.e., better vision) and patients with LogMAR BCVA higher than 0.6 LogMAR (i.e., worse vision). The minimisation will be performed by the study team using the online allocation software QMinim.
Masking
Outcomes Assessor
Masking Description
Due to the nature of the study, the treating surgeons will be unblinded to the graft type. The outcomes will be assess by a blinded assessor and the quality of life questionnaires will be completed by the patient themselves, with assistance from the blinded assessor as needed.
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UT-DSAEK
Arm Type
Active Comparator
Arm Description
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.
Arm Title
DMEK
Arm Type
Active Comparator
Arm Description
Descemet membrane endothelial keratoplasty refers to the use of a corneal endothelial/Descemet graft with no layer of associated stroma (15-20um thick)
Intervention Type
Procedure
Intervention Name(s)
DSAEK
Other Intervention Name(s)
Descemet Stripping Automated Endothelial Keratoplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
DMEK
Other Intervention Name(s)
Descemet Membrane Endothelial Keratoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
BCVA 12m
Description
Best-corrected visual acuity expressed in LogMAR
Time Frame
12 months
Secondary Outcome Measure Information:
Title
BCVA 3 and 6m
Description
Best-corrected visual acuity expressed in LogMAR
Time Frame
3 and 6 months
Title
UCVA 3,6 and12m
Description
Uncorrected visual acuity expressed in LogMAR
Time Frame
3, 6 and 12 months
Title
Change in refraction
Description
Change in objective refraction - spectacle correction
Time Frame
3, 6 and 12 months
Title
Proportion of high vision
Description
Proportion of patients to achieve 0.2 LogMAR visual acuity or less
Time Frame
12 months
Title
EQ-5D-5L
Description
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
Time Frame
3, 6 and 12 months
Title
VFQ 25
Description
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.
Time Frame
3, 6 and 12 months
Title
ECC
Description
Endothelial cell count
Time Frame
3, 6 and 12 months
Title
CCT
Description
Central corneal thickness
Time Frame
3, 6 and 12 months
Title
Complications
Description
Complications associated with the intervention
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veerle Van Gerwen, BSc
Phone
+3238210000
Ext
5271
Email
bestcornea@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Deconinck, BSc
Phone
+3238210000
Ext
2466
Email
bestcornea@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sorcha Ni Dhubhghaill, MBBCh, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carina Koppen, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernard Duchesne, MD, PhD
Organizational Affiliation
University Hospital Liege
Official's Role
Study Chair
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
veerle Van Gerwen, BSc
Email
veerle.vangerwen@uza.be
First Name & Middle Initial & Last Name & Degree
Sorcha Ni Dhubhghaill, PhD
First Name & Middle Initial & Last Name & Degree
Carina Koppen, PhD
Facility Name
AZ Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilse Claerhout, PhD
Email
Ilse.Claerhout@azmmsj.be
First Name & Middle Initial & Last Name & Degree
Ilse Claerhout, PhD
Facility Name
AZ Sint-Jan Brugge
City
Brugge
State/Province
West-Vlaanderen
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liesbeth Laloo
Email
Liesbeth.Laloo@azsintjan.be
First Name & Middle Initial & Last Name & Degree
Sophie De Craene, MD
Facility Name
AZ Imelda
City
Bonheiden
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Deroy
Email
leslie.deroy@imelda.be
First Name & Middle Initial & Last Name & Degree
Karolien Termote, MD
Facility Name
Erasmus ziekenhuis Brussel
City
Brussel
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Schrooyen
Email
Marc.Schrooyen@erasme.ulb.ac.be
First Name & Middle Initial & Last Name & Degree
Marc Schrooyen, PhD
First Name & Middle Initial & Last Name & Degree
Pauline le Roux, MD
First Name & Middle Initial & Last Name & Degree
Fayçal Moujane, MD
Facility Name
UZ Brussel
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bert Verhelst
Email
bert.verhelst@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Karolien Termote, MD
Facility Name
AZ Monica (campus Deurne)
City
Deurne
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Lamoen
Email
caroline.lamoen@azmonica.be
First Name & Middle Initial & Last Name & Degree
Isabel Bleyen, MD
Facility Name
Ziekenhuis Oost-Limburg (ZOL)
City
Genk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frauke Somers
Email
frauke.somers@zol.be
First Name & Middle Initial & Last Name & Degree
Sacha Gast, MD
Facility Name
UZ Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Sambaer
Email
octu@uzgent.be
First Name & Middle Initial & Last Name & Degree
Dimitri Roels, MD
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge Vriens
Email
ingeborg.vriens@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Heleen Delbeke, PhD
First Name & Middle Initial & Last Name & Degree
Isabelle Saelens, PhD
Facility Name
CHU Liège
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Séverine Camby
Email
s.camby@chuliege.be
First Name & Middle Initial & Last Name & Degree
Bernard Duchense, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

The Belgian Endothelial Surgical Transplant of the Cornea

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