DMEK is superior to DSAEK in terms of (rate of) VA rehabilitation.
ID
Bron
Aandoening
Fuchs'endothelial dysthrophy
and indication for keratoplasty
Ondersteuning
PO Box 70030
3000 LM Rotterdam
010- 401 77 77
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of letters gained 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 VA.
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 favorable but the risk of detachment is higher. Assessments for this study are non-invasive and inconvenience is negligible, extra time required is approximately 1 hour per visit (5X).
Doel van het onderzoek
DMEK is superior to DSAEK in terms of (rate of) VA rehabilitation.
Onderzoeksopzet
baseline, 1,3,6,12 month
Onderzoeksproduct en/of interventie
Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UTDSAEK)
Descemet Stripping Automated Endothelial Keratoplasty (DMAEK)
Publiek
J van Rooij
PO Box 70030
Rotterdam 3000 LM
The Netherlands
010- 402 34 49
roi@oogziekenhuis.nl
Wetenschappelijk
J van Rooij
PO Box 70030
Rotterdam 3000 LM
The Netherlands
010- 402 34 49
roi@oogziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age ≥ 18 years
- Informed consent.
- Fuchs endothelial dystrophy.
- VA < 0.6 (Snellen).
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
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4805 |
| NTR-old | NTR4945 |
| Ander register | NL50956.078.14 : OZR 2014-20 |