Fuchs' Endothelial DystrophyNCT03407755
Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
A study testing Intraocular gas in people with Fuchs' Endothelial Dystrophy and Bullous Keratopathy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Dystrophy, Bullous Keratopathy
- What is being tested?
- Intraocular gas
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for DMEK surgey
Who cannot join
- Related to ocular health
- Re-DMEK or prior penetrating keratoplasty
- Ocular hypertension resistant to topical medication
- Previous vitrectomy
- Minimally invasive glaucoma devices
- Aphakia
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Glostrup Hospital, University of Copenhagen
Glostrup Municipality, 2600
Mark Alberti, mark.jensen.alberti@regionh.dk
About this study
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
- Conditions
- Fuchs' Endothelial Dystrophy, Bullous Keratopathy
- Being tested
- Intraocular gas
- Keywords
- Intraocular gas, Positioning, DMEK, Endothelial keratoplasty
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular gasProcedure or surgery
Participants randomized to either air or SF6 gas in the anterior chamber.
| Study group | Role | What they receive |
|---|---|---|
| Air | Active comparator | Intraocular 100% atmospheric air (anterior chamber). Receives: Procedure: Intraocular gas |
| SF6 | Experimental | Intraocular 20% sulphur hexaflouride (anterior chamber). Receives: Procedure: Intraocular gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft detachment
Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.
Measured: Occurence within 3 months postoperative
Secondary outcomes (4)
Visual acuity
Snellen chart (logMAR)
Measured: 3 months postoperative
Gas fill
Postoperative gas fill measured by OCT.
Measured: Serial measurements during postoperative week 1.
Positioning
Pitch and roll of head using positioning device
Measured: 72 hours postoperative
Complications
Any adverse outcome affecting the eye
Measured: Occurence within 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start15 Sep 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized to either air or sulfur hexafluoride (SF6)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Alberti, Glostrup University Hospital, Copenhagen
- Investigators
- Mark Alberti, MD, Study director, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407755
- Sponsor's protocol ID
- H-17006354
- Status last verified
- Feb 2019
- First submitted
- 15 Jan 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If permitted by the Danish Data Protection Agency
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
- ClinicalTrials.gov ID
- NCT03407755
- Acronym / sponsor ID
- H-17006354
- Conditions
- Fuchs' Endothelial Dystrophy, Bullous Keratopathy
- Keywords
- Intraocular gas, Positioning, DMEK, Endothelial keratoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients randomized to either air or sulfur hexafluoride (SF6)
| Arm | Type | Receives |
|---|---|---|
| Air | Active comparator | Procedure: Intraocular gasIntraocular 100% atmospheric air (anterior chamber). |
| SF6 | Experimental | Procedure: Intraocular gasIntraocular 20% sulphur hexaflouride (anterior chamber). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible for DMEK surgey
Key exclusion criteria (23 listed)
- Related to ocular health
- Re-DMEK or prior penetrating keratoplasty
- Ocular hypertension resistant to topical medication
- Previous vitrectomy
- Minimally invasive glaucoma devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular gasParticipants randomized to either air or SF6 gas in the anterior chamber. | Procedure or surgery | Air, SF6 |
Primary outcome
Graft detachment
Time frame: Occurence within 3 months postoperative
Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.
4 secondary outcomes
Visual acuity
Time frame: 3 months postoperative
Gas fill
Time frame: Serial measurements during postoperative week 1.
Positioning
Time frame: 72 hours postoperative
Complications
Time frame: Occurence within 3 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided. If permitted by the Danish Data Protection Agency
Related trials for Fuchs' Endothelial Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Alberti, MD study director
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular gas in people with Fuchs' Endothelial Dystrophy and Bullous Keratopathy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Alberti, MD (+4538634823, malb0038@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft detachment (time frame: Occurence within 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.