Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
NCT ID: NCT03407755
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
104 participants
INTERVENTIONAL
2017-09-15
2020-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Air
Intraocular 100% atmospheric air (anterior chamber).
Intraocular gas
Participants randomized to either air or SF6 gas in the anterior chamber.
SF6
Intraocular 20% sulphur hexaflouride (anterior chamber).
Intraocular gas
Participants randomized to either air or SF6 gas in the anterior chamber.
Interventions
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Intraocular gas
Participants randomized to either air or SF6 gas in the anterior chamber.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Mark Alberti
Principal Investigator
Principal Investigators
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Mark Alberti, MD
Role: STUDY_DIRECTOR
Rigshospitalet - Glostrup
Locations
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Glostrup Hospital, University of Copenhagen
Glostrup Municipality, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-17006354
Identifier Type: -
Identifier Source: org_study_id
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