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

Glostrup University Hospital, Copenhagen

Status: Unknown

Conditions: Bullous Keratopathy; Fuchs' Endothelial Dystrophy

Treatments: Procedure: Intraocular gas

Study type: Interventional

Funder types: Other

Identifiers

NCT03407755

H-17006354

Details and patient eligibility

About

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

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

104 participants in 2 patient groups

Air

Active Comparator group

Description:

Intraocular 100% atmospheric air (anterior chamber).

Treatment:

Procedure: Intraocular gas

SF6

Experimental group

Description:

Intraocular 20% sulphur hexaflouride (anterior chamber).

Treatment:

Procedure: Intraocular gas