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

Sponsor
Glostrup University Hospital, Copenhagen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03407755
Collaborator
(none)
104
Enrollment
1
Location
2
Arms
31.5
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intraocular gas
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients randomized to either air or sulfur hexafluoride (SF6)Patients randomized to either air or sulfur hexafluoride (SF6)
Masking:
Double (Participant, Investigator)
Masking Description:
Surgeon and patient masked to choice of intraocular gas. Study coordinator not masked.
Primary Purpose:
Treatment
Official Title:
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
Actual Study Start Date :
Sep 15, 2017
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Air

Intraocular 100% atmospheric air (anterior chamber).

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

Intraocular 20% sulphur hexaflouride (anterior chamber).

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

Outcome Measures

Primary Outcome Measures

  1. Graft detachment [Occurence within 3 months postoperative]

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

Secondary Outcome Measures

  1. Visual acuity [3 months postoperative]

    Snellen chart (logMAR)

  2. Gas fill [Serial measurements during postoperative week 1.]

    Postoperative gas fill measured by OCT.

  3. Positioning [72 hours postoperative]

    Pitch and roll of head using positioning device

  4. Complications [Occurence within 3 months postoperative]

    Any adverse outcome affecting the eye

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Glostrup Hospital, University of Copenhagen Glostrup Denmark 2600

Sponsors and Collaborators

  • Glostrup University Hospital, Copenhagen

Investigators

  • Study Director: Mark Alberti, MD, Rigshospitalet - Glostrup

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Alberti, Principal Investigator, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT03407755
Other Study ID Numbers:
  • H-17006354
First Posted:
Jan 23, 2018
Last Update Posted:
Feb 15, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mark Alberti, Principal Investigator, Glostrup University Hospital, Copenhagen
Intraocular gas
Positioning
DMEK
Endothelial keratoplasty
Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Feb 15, 2019