Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
1 other identifier
interventional
104
1 country
1
Brief Summary
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2017
CompletedFirst Submitted
Initial submission to the registry
January 15, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFebruary 15, 2019
February 1, 2019
2.3 years
January 15, 2018
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Graft detachment
Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.
Occurence within 3 months postoperative
Secondary Outcomes (4)
Visual acuity
3 months postoperative
Gas fill
Serial measurements during postoperative week 1.
Positioning
72 hours postoperative
Complications
Occurence within 3 months postoperative
Study Arms (2)
Air
ACTIVE COMPARATORIntraocular 100% atmospheric air (anterior chamber).
SF6
EXPERIMENTALIntraocular 20% sulphur hexaflouride (anterior chamber).
Interventions
Participants randomized to either air or SF6 gas in the anterior chamber.
Eligibility Criteria
You may qualify if:
- \- Eligible for DMEK surgey
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glostrup Hospital, University of Copenhagen
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Alberti, MD
Glostrup University Hospital, Copenhagen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Surgeon and patient masked to choice of intraocular gas. Study coordinator not masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 15, 2018
First Posted
January 23, 2018
Study Start
September 15, 2017
Primary Completion
December 31, 2019
Study Completion
May 1, 2020
Last Updated
February 15, 2019
Record last verified: 2019-02