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

February 14, 2019 updated by: Mark Alberti, Glostrup University Hospital, Copenhagen
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft detachment
Time Frame: Occurence within 3 months postoperative
Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.
Occurence within 3 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 3 months postoperative
Snellen chart (logMAR)
3 months postoperative
Gas fill
Time Frame: Serial measurements during postoperative week 1.
Postoperative gas fill measured by OCT.
Serial measurements during postoperative week 1.
Positioning
Time Frame: 72 hours postoperative
Pitch and roll of head using positioning device
72 hours postoperative
Complications
Time Frame: Occurence within 3 months postoperative
Any adverse outcome affecting the eye
Occurence within 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

January 15, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17006354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If permitted by the Danish Data Protection Agency

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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