The Belgian Endothelial Surgical Transplant of the Cornea

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура UT-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 h
• Процедура 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 b

Первичные конечные точки

• BCVA 12m [Срок оценки: 12 months]

Вторичные конечные точки (9)

• BCVA 3 and 6m [Срок оценки: 3 and 6 months]
• UCVA 3,6 and12m [Срок оценки: 3, 6 and 12 months]
• Change in refraction [Срок оценки: 3, 6 and 12 months]
• Proportion of high vision [Срок оценки: 12 months]
• EQ-5D-5L [Срок оценки: 3, 6 and 12 months]
• VFQ 25 [Срок оценки: 3, 6 and 12 months]
• ECC [Срок оценки: 3, 6 and 12 months]
• CCT [Срок оценки: 3, 6 and 12 months]
• Complications [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 11 центров

• Antwerp University Hospital — Edegem
• AZ Maria Middelares — Ghent
• AZ Sint-Jan Brugge — Bruges
• AZ Imelda — Bonheiden
• Erasmus ziekenhuis Brussel — Brussels
• UZ Brussel — Brussels
• AZ Monica (campus Deurne) — Deurne
• Ziekenhuis Oost-Limburg (ZOL) — Genk
• … и ещё 3 центра

Публикации

• de Bruyn B, Ni Dhubhghaill S, Claerhout I, Claes K, Deconinck A, Delbeke H, Huizing M, Krolo I, Muijzer M, Oellerich S, Roels D, Termote K, Van den Bogerd B, Van Gerwen V, Verhaegen I, Wisse R, Wouters K, Consortium TBC, Duchesne B, Koppen C. Belgian Endothelial Surgical Transplant of the Cornea (BEST cornea) protocol: clinical and patient-reported outcomes of Ultra-Thin Descemet Stripping Automat PMID 37714670

Идентификаторы

NCT: NCT05436665 · UZAntwerpen

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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