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

Glostrup University Hospital, Copenhagen104 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

104

Conditions

Fuchs' Endothelial Dystrophy Bullous Keratopathy

Interventions

Intraocular gasPROCEDURE

Participants randomized to either air or SF6 gas in the anterior chamber.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Glostrup Hospital, University of Copenhagen

Glostrup Municipality, Denmark

RECRUITING

Outcomes

Primary Outcomes

Graft detachment

Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.

Time frame: Occurence within 3 months postoperative

Secondary Outcomes

Visual acuity

Snellen chart (logMAR)

Time frame: 3 months postoperative

Gas fill

Postoperative gas fill measured by OCT.

Time frame: Serial measurements during postoperative week 1.

Positioning

Pitch and roll of head using positioning device

Time frame: 72 hours postoperative

Complications

Any adverse outcome affecting the eye

Time frame: Occurence within 3 months postoperative

Central Contacts

Mark Alberti, MD

CONTACT

+4538634823 malb0038@regionh.dk

Data from ClinicalTrials.gov

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