Status:
UNKNOWN
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Conditions:
Fuchs' Endothelial Dystrophy
Bullous Keratopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
Eligibility Criteria
Inclusion
- \- Eligible for DMEK surgey
Exclusion
- Related to ocular health
- Re-DMEK or prior penetrating keratoplasty
- Ocular hypertension resistant to topical medication
- Previous vitrectomy
- Minimally invasive glaucoma devices
- Aphakia
- Anterior chamber or iris claw lens
- Implantable Collamer Lens (ICL)
- Clinically significant corneal scarring
- Central corneal thickness \>750 µm
- BCVA \< 0.1
- Related to general health
- Not able to give informed consent
- Inability to position correctly due to organic or psychological condition.
- Related to surgical procedure
- Graft diameter \>9 mm or \< 7mm
- Graft central endothelial cell count \< 2000 cells/mm2
- Graft unfolding duration \>1 hour
- Graft morphology grade 4-5
- Significant graft decentration (graft contour not visible in microscope)
- Significant presence of Descemet remnants in the graft-host interface
- Presence of inward folds
- Graft 'stroma-surface' placed facing away from recipient stroma
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03407755
Start Date
September 15 2017
End Date
May 1 2020
Last Update
February 15 2019
Active Locations (1)
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1
Glostrup Hospital, University of Copenhagen
Glostrup Municipality, Denmark, 2600