The Belgian Endothelial Surgical Transplant of the Cornea

Fuchs' Endothelial Dystrophy Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436665
• Other study ID #: UZAntwerpen
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Antwerp
• Contact: Veerle Van Gerwen, BSc
• Phone: +3238210000
• Email: bestcornea[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bullous Keratopathy
• Corneal Edema
• Corneal Endothelial Disorder
• Fuchs' Endothelial Dystrophy
• Pseudophakic Bullous Keratopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	AZ Imelda	Bonheiden
Belgium	AZ Sint-Jan Brugge	Brugge	West-Vlaanderen
Belgium	Erasmus ziekenhuis Brussel	Brussel
Belgium	UZ Brussel	Brussel
Belgium	AZ Monica (campus Deurne)	Deurne
Belgium	Antwerp University Hospital	Edegem	Antwerp
Belgium	Ziekenhuis Oost-Limburg (ZOL)	Genk
Belgium	AZ Maria Middelares	Gent	Oost-Vlaanderen
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHU Liège	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Belgium Health Care Knowledge Centre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA 12m	Best-corrected visual acuity expressed in LogMAR	12 months
Secondary	BCVA 3 and 6m	Best-corrected visual acuity expressed in LogMAR	3 and 6 months
Secondary	UCVA 3,6 and12m	Uncorrected visual acuity expressed in LogMAR	3, 6 and 12 months
Secondary	Change in refraction	Change in objective refraction - spectacle correction	3, 6 and 12 months
Secondary	Proportion of high vision	Proportion of patients to achieve 0.2 LogMAR visual acuity or less	12 months
Secondary	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
Secondary	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
Secondary	ECC	Endothelial cell count	3, 6 and 12 months
Secondary	CCT	Central corneal thickness	3, 6 and 12 months
Secondary	Complications	Complications associated with the intervention	12 months