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NCT Number: NCT05436665

The Belgian Endothelial Surgical Transplant of the Cornea

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.

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Key information

Conditions

Corneal Edema Bullous Keratopathy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Endothelial Disorder Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Pseudophakic Bullous Keratopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital, Edegem, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UT-DSAEK

Procedure

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: Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty

DMEK

Procedure

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

Primary outcomes

  1. BCVA 12m

    Time frame: 12 months

    Best-corrected visual acuity expressed in LogMAR

Secondary outcomes

  1. BCVA 3 and 6m

    Time frame: 3 and 6 months

    Best-corrected visual acuity expressed in LogMAR

  2. UCVA 3,6 and12m

    Time frame: 3, 6 and 12 months

    Uncorrected visual acuity expressed in LogMAR

  3. Change in refraction

    Time frame: 3, 6 and 12 months

    Change in objective refraction - spectacle correction

  4. Proportion of high vision

    Time frame: 12 months

    Proportion of patients to achieve 0.2 LogMAR visual acuity or less

  5. EQ-5D-5L

    Time frame: 3, 6 and 12 months

    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

  6. VFQ 25

    Time frame: 3, 6 and 12 months

    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.

  7. ECC

    Time frame: 3, 6 and 12 months

    Endothelial cell count

  8. CCT

    Time frame: 3, 6 and 12 months

    Central corneal thickness

  9. Complications

    Time frame: 12 months

    Complications associated with the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Axelle Belis, BSc

CONTACT

[email protected]

+3238210000 ext. 2466

Veerle Van Gerwen, BSc

CONTACT

[email protected]

+3238210000 ext. 5271

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Belgium Health Care Knowledge Centre

Registry information

Official study 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)

Acronym: BESTCornea

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2022
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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