RecruitingNot ApplicableNCT05436665

The Belgian Endothelial Surgical Transplant of the Cornea

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)


Sponsor

University Hospital, Antwerp

Enrollment

220 participants

Start Date

Aug 10, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks outcomes for patients in Belgium who undergo a type of corneal transplant called DMEK or DSAEK — procedures that replace only the diseased inner lining of the cornea (the endothelial layer) rather than the full thickness. It looks at vision quality, safety, and patient quality of life after this kind of surgery. You may be eligible if: - You are 18 or older and can read and understand study information - You have Fuchs endothelial dystrophy, bullous keratopathy, or another cause of corneal endothelial dysfunction - You have already had cataract surgery (pseudophakic) or plan to have it combined with corneal surgery - You are able and willing to attend follow-up visits at 3, 6, and 12 months You may NOT be eligible if: - You cannot provide informed consent - You are unable to attend follow-up appointments - This eye is your second eye being enrolled (only one eye per patient) - You have complex combined surgery including glaucoma surgery at the same time - You are pregnant or breastfeeding - You are under 18 - You still have your natural lens and no plan for cataract surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUT-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.

PROCEDUREDMEK

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(11)

Antwerp University Hospital

Edegem, Antwerp, Belgium

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, Belgium

AZ Imelda

Bonheiden, Belgium

Erasmus ziekenhuis Brussel

Brussels, Belgium

UZ Brussel

Brussels, Belgium

AZ Monica (campus Deurne)

Deurne, Belgium

Ziekenhuis Oost-Limburg (ZOL)

Genk, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

CHU Liège

Liège, Belgium

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NCT05436665


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