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

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ClinicalTrials.gov Identifier: NCT03407755
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Alberti, Glostrup University Hospital, Copenhagen

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
Fuchs' Endothelial Dystrophy Bullous Keratopathy Procedure: Intraocular gas Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : September 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Graft detachment [ Time Frame: 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 [ Time Frame: 3 months postoperative ]
    Snellen chart (logMAR)

  2. Gas fill [ Time Frame: Serial measurements during postoperative week 1. ]
    Postoperative gas fill measured by OCT.

  3. Positioning [ Time Frame: 72 hours postoperative ]
    Pitch and roll of head using positioning device

  4. Complications [ Time Frame: Occurence within 3 months postoperative ]
    Any adverse outcome affecting the eye



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407755


Contacts
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Contact: Mark Alberti, MD +4538634823 malb0038@regionh.dk

Locations
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Denmark
Glostrup Hospital, University of Copenhagen Recruiting
Glostrup, Denmark, 2600
Contact: Mark Alberti       mark.jensen.alberti@regionh.dk   
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
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Study Director: Mark Alberti, MD Rigshospitalet - Glostrup

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Responsible Party: Mark Alberti, Principal Investigator, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT03407755     History of Changes
Other Study ID Numbers: H-17006354
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If permitted by the Danish Data Protection Agency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark Alberti, Glostrup University Hospital, Copenhagen:
Intraocular gas
Positioning
DMEK
Endothelial keratoplasty

Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn