Fuchs' Endothelial DystrophySUPER-DMEKNCT05399095
Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty
A study testing Supine positioning: 5 days and Supine positioning: 1 days in people with Fuchs' Endothelial Dystrophy, run by University Eye Hospital, Freiburg at 1 site in Germany.
Trial summary
This randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- What is being tested?
- Supine positioning: 5 days and Supine positioning: 1 days
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 23 May 2022to 23 May 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
- Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
Who cannot join
- Other corneal diseases (i.e. corneal scars, corneal dystrophies except FECD, corneal inflammation / infection)
- Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, use of contact lenses in past four weeks, anesthetic eye drops)
- Diabetes mellitus with endorgan complications)
- Lack of fixation during corneal tomography
- Bedridden
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Center - University of Freiburg, Eye Hospital
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
Official title: Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: a Randomized Controlled Trial
This randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD).
Read the detailed description
In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the patients own cornea. Supine positioning is thought to improve attachment by using the tamponade effect of the bubble. At present, it is unclear how long supine positioning is required. Positioning regimens vary between one hour to over one week. In this trial, the investigators will assess if prolonged supine positioning for 5 days improves graft attachment and long-term outcomes compared to supine positioning for 1 day.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- Supine positioning: 5 days, Supine positioning: 1 days
- Keywords
- Fuchs' endothelial corneal dystrophy, Descemet membrane endothelial keratoplasty, Incomplete graft attachment, Endothelial corneal graft detachment, Rebubbling (repeat injection of air or gas in the anterior chamber), Supine positioning, Postoperative posture, Anterior segment optical coherence tomography, Neural network, Machine learning, Randomized controlled trial
- 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.
Supine positioning: 5 daysBehavioural
Supine positioning for 5 days after DMEK
Supine positioning: 1 daysBehavioural
Supine positioning for 1 days after DMEK
| Study group | Role | What they receive |
|---|---|---|
| 5 days supine positioning | Experimental | Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour. Receives: Behavioral: Supine positioning: 5 days |
| 1 day supine positioning followed by usual physical activity for 4 days | Active comparator | Supine positioning for 1 days after DMEK with upright positioning for only 10 min every hour. Receives: Behavioral: Supine positioning: 1 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft attachment
Area of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
Measured: At two weeks after DMEK
Graft attachment
Volume of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
Measured: At two weeks after DMEK
Secondary outcomes (10)
Rebubbling
Number of eyes with secondary injection of air after DMEK
Measured: At two weeks and 3 months after DMEK
Safety of supine positioning
Adverse events (AE) and serious AEs (SAE)
Measured: At two weeks and 3 months after DMEK
Subjective visual function
Subjective visual function on a scale from 0 (worse vision) to 10 (best vision) with higher scores meaning better subjective visual function
Measured: At 3, 12, and 24 months after DMEK
Visual acuity
Best-corrected visual acuity to determine visual acuity in letters
Measured: At 3, 12, and 24 months after DMEK
Disability glare
Straylight meter measurement to determine forward scatter in logs straylight parameter
Measured: At 3, 12, and 24 months after DMEK
Graft health: endothelial cell density
Specular microscopy to determine endothelial cell density
Measured: At 3, 12, and 24 months after DMEK
Graft health
Slit-lamp exam to identify signs of graft rejection
Measured: At 12, and 24 months after DMEK
Patient-reported visual disability
The Visual Acuity Factor and Glare Factor of the Visual Function and Corneal Health Status (V-FUCHS) instrument. The instrument's scores are Rasch-analysis based scores expressed in logits. Participants with more difficulty have higher or more positive V-FUCHS scores.
Measured: At 3, 12, and 24 months after DMEK
Corneal edema
Tomography to determine corneal edema in µm
Measured: At 2 weeks and at 3, 12, and 24 months after DMEK
Corneal backscatter
Tomography to determine corneal backscatter in scatter units (SU)
Measured: At 3, 12, and 24 months after DMEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start23 May 2022
- Primary completion23 May 2023
- Study completion23 May 2023
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
- Stratification will be performed according to the surgical procedure (DMEK alone or DMEK combined cataract surgery). Within each strata, participants will be randomized in a 1:1 ratio to 5 days (intervention) and 1 day (control) postoperative supine positioning.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Eye Hospital, Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrin Wacker, MD FEBO, Principal investigator, University of Freiburg, Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399095
- Sponsor's protocol ID
- ETK 22-1101
- Acronym
- SUPER-DMEK
- Status last verified
- Jul 2023
- First submitted
- 22 May 2022
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05399095
- Acronym / sponsor ID
- SUPER-DMEK / ETK 22-1101
- Conditions
- Fuchs' Endothelial Dystrophy
- Keywords
- Fuchs' endothelial corneal dystrophy, Descemet membrane endothelial keratoplasty, Incomplete graft attachment, Endothelial corneal graft detachment, Rebubbling (repeat injection of air or gas in the anterior chamber), Supine positioning, Postoperative posture, Anterior segment optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Eye Hospital, FreiburgUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 1 Jun 2022 (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 randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD).
Detailed description
In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the patients own cornea. Supine positioning is thought to improve attachment by using the tamponade effect of the bubble. At present, it is unclear how long supine positioning is required. Positioning regimens vary between one hour to over one week. In this trial, the investigators will assess if prolonged supine positioning for 5 days improves graft attachment and long-term outcomes compared to supine positioning for 1 day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Stratification will be performed according to the surgical procedure (DMEK alone or DMEK combined cataract surgery). Within each strata, participants will be randomized in a 1:1 ratio to 5 days (intervention) and 1 day (control) postoperative supine positioning.
| Arm | Type | Receives |
|---|---|---|
| 5 days supine positioning | Experimental | Behavioral: Supine positioning: 5 daysSupine positioning for 5 days after DMEK with upright positioning for only 10 min every hour. |
| 1 day supine positioning followed by usual physical activity for 4 days | Active comparator | Behavioral: Supine positioning: 1 daysSupine positioning for 1 days after DMEK with upright positioning for only 10 min every hour. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
- Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
Key exclusion criteria (5 listed)
- Other corneal diseases (i.e. corneal scars, corneal dystrophies except FECD, corneal inflammation / infection)
- Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, use of contact lenses in past four weeks, anesthetic eye drops)
- Diabetes mellitus with endorgan complications)
- Lack of fixation during corneal tomography
- Bedridden
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 |
|---|---|---|
| Supine positioning: 5 daysSupine positioning for 5 days after DMEK | Behavioural | 5 days supine positioning |
| Supine positioning: 1 daysSupine positioning for 1 days after DMEK | Behavioural | 1 day supine positioning followed by usual physical activity for 4 days |
Primary outcome
Graft attachment
Time frame: At two weeks after DMEK
Area of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
Graft attachment
Time frame: At two weeks after DMEK
Volume of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
10 secondary outcomes
Rebubbling
Time frame: At two weeks and 3 months after DMEK
Safety of supine positioning
Time frame: At two weeks and 3 months after DMEK
Subjective visual function
Time frame: At 3, 12, and 24 months after DMEK
Visual acuity
Time frame: At 3, 12, and 24 months after DMEK
Disability glare
Time frame: At 3, 12, and 24 months after DMEK
Graft health: endothelial cell density
Time frame: At 3, 12, and 24 months after DMEK
Graft health
Time frame: At 12, and 24 months after DMEK
Patient-reported visual disability
Time frame: At 3, 12, and 24 months after DMEK
Corneal edema
Time frame: At 2 weeks and at 3, 12, and 24 months after DMEK
Corneal backscatter
Time frame: At 3, 12, and 24 months after DMEK
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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.
Katrin Wacker, MD FEBO principal investigator
University of Freiburg, Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine positioning: 5 days and Supine positioning: 1 days in people with Fuchs' Endothelial Dystrophy, run by University Eye Hospital, Freiburg at 1 site in Germany.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jul 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft attachment (time frame: At two weeks after DMEK). The study lists 2 primary outcomes in all. 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 25 Jul 2023.