Fuchs' Endothelial Dystrophy Clinical Trial
Official title:
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
Status | Recruiting |
Enrollment | 104 |
Est. completion date | May 1, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Eligible for DMEK surgey Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Glostrup Hospital, University of Copenhagen | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Glostrup University Hospital, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Graft detachment | Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT. | Occurence within 3 months postoperative | |
Secondary | Visual acuity | Snellen chart (logMAR) | 3 months postoperative | |
Secondary | Gas fill | Postoperative gas fill measured by OCT. | Serial measurements during postoperative week 1. | |
Secondary | Positioning | Pitch and roll of head using positioning device | 72 hours postoperative | |
Secondary | Complications | Any adverse outcome affecting the eye | Occurence within 3 months postoperative |
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