Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)

Study Overview
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Brief Summary
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This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.

Official Title
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Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)

Conditions
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Fuchs' Endothelial Dystrophy, Bullous Keratopathy

Intervention / Treatment
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* Procedure: Intraocular gas


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients randomized to either air or sulfur hexafluoride (SF6)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Air<br>Intraocular 100% atmospheric air (anterior chamber). | Procedure: Intraocular gas<br>* Participants randomized to either air or SF6 gas in the anterior chamber.<br>|
| Experimental: SF6<br>Intraocular 20% sulphur hexaflouride (anterior chamber). | Procedure: Intraocular gas<br>* Participants randomized to either air or SF6 gas in the anterior chamber.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft detachment | Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT. | Occurence within 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Snellen chart (logMAR) | 3 months postoperative | 
| Gas fill | Postoperative gas fill measured by OCT. | Serial measurements during postoperative week 1. | 
| Positioning | Pitch and roll of head using positioning device | 72 hours postoperative | 
| Complications | Any adverse outcome affecting the eye | Occurence within 3 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular gas, Positioning, DMEK, Endothelial keratoplasty