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Status unknownNCT03407755Updated Feb 15, 2019

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

An interventional study of Intraocular gas in Fuchs' Endothelial Dystrophy and Bullous Keratopathy, sponsored by Glostrup University Hospital, Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Glostrup University Hospital, Copenhagen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Fuchs' Endothelial Dystrophy
  • Bullous Keratopathy

Keywords

  • Intraocular gas
  • Positioning
  • DMEK
  • Endothelial keratoplasty
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eligible for DMEK surgey

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
104 participants (estimated)

Study arms

  • Active comparator
    Air

    Intraocular 100% atmospheric air (anterior chamber).

    Procedure: Intraocular gas

  • Experimental
    SF6

    Intraocular 20% sulphur hexaflouride (anterior chamber).

    Procedure: Intraocular gas

Interventions

  • ProcedureIntraocular gas

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

05

What researchers measure

Primary outcomes

  1. 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

  1. Visual acuity

    Snellen chart (logMAR)

    Time frame: 3 months postoperative

  2. Gas fill

    Postoperative gas fill measured by OCT.

    Time frame: Serial measurements during postoperative week 1.

  3. Positioning

    Pitch and roll of head using positioning device

    Time frame: 72 hours postoperative

  4. Complications

    Any adverse outcome affecting the eye

    Time frame: Occurence within 3 months postoperative

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — If permitted by the Danish Data Protection Agency

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03407755
Lead sponsor
Glostrup University Hospital, Copenhagen
Responsible party
Mark Alberti (Principal Investigator, Glostrup University Hospital, Copenhagen) — Principal investigator
First posted
Jan 23, 2018
Start date
Sep 15, 2017
Primary completion
Dec 31, 2019 (estimated)
Completion
May 1, 2020 (estimated)
Last update
Feb 15, 2019

Study contacts

Mark Alberti, MD
Contact
malb0038@regionh.dk
+4538634823
Mark Alberti, MD
study director · Rigshospitalet - Glostrup

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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