DMEK is superior to DSAEK
ID
Bron
Verkorte titel
Aandoening
Fuchs’ endothelial dystrophy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Best corrected visual acuity (BCVA) at 12 months
Achtergrond van het onderzoek
Rationale: With advanced stages of Fuchs’ endothelial dystrophy (FED), keratoplasty is the only manner to restore vision. Although lamellar techniques, nowadays, are generally prefered, there is an ongoing debate whether Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK) or Descemet Membrane Endothelial Keratoplasty (DMEK) should be the procedure of choice in FED.
Objective: To demonstrate that DMEK is superior to DSAEK with respect to visual acuity and quality of vision.
Study design: Randomised, comparative.
Study population: Patients with FED indicated for keratoplasty.
Intervention: UTDSAEK or DMEK.
Main study parameters/endpoints: Number of letters gained at 12 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The outcome of DMEK may be more favourable but the technique is challenging and the risk of graft detachment may be higher. Assessments for this study are non-invasive and inconvenience is negligible, extra time required is maximally 1 hour per visit (5X; total time 4 h).
Doel van het onderzoek
DMEK is superior to DSAEK
Onderzoeksopzet
Baseline and 1, 3, 6, 12 months postoperatively
Onderzoeksproduct en/of interventie
Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK)
or
Descemet Membrane Endothelial Keratoplasty (DMEK)
Publiek
Rene Wubbels
010 4023430
r.wubbels@oogziekenhuis.nl
Wetenschappelijk
Rene Wubbels
010 4023430
r.wubbels@oogziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age ≥ 18 years.
- Informed consent.
- Fuchs’ endothelial dystrophy.
- VA < 0.6 (Snellen).
- Pseudophakia.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Unable to attend the FU visits.
- Previous keratoplasty in the eye to be included.
- Severe progressive glaucoma (stable glaucoma on topical therapy is excepted).
- History of retinal surgery, glaucoma surgery or age related macular disease.
- Amblyopia.
- Expected postoperative VA < 0.6.
- Corneal neovascularisation > 1 quadrant.
- Indication for typed graft.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8938 |
| Ander register | METC Erasmus MC : MEC-2020-0761 |