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

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03407755
• Other study ID #: H-17006354
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2019
• Source: Glostrup University Hospital, Copenhagen
• Contact: Mark Alberti, MD
• Phone: +4538634823
• Email: malb0038[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bullous Keratopathy
• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• Intraocular gas
Participants randomized to either air or SF6 gas in the anterior chamber.

Locations

Country	Name	City	State
Denmark	Glostrup Hospital, University of Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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