Fuchs Endothelial Corneal DystrophySUPINENCT07373821
Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)
A study testing Duration of Supine Positioning in people with Fuchs Endothelial Corneal Dystrophy and Descemet Membrane Endothelial Keratoplasty (DMEK), run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn if a longer period of lying on the back after corneal transplant surgery (Descemet Membrane Endothelial Keratoplasty, DMEK) helps the transplant stick better in the eye. It will also learn about side effects, such as back pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fuchs Endothelial Corneal Dystrophy, Descemet Membrane Endothelial Keratoplasty (DMEK)
- What is being tested?
- Duration of Supine Positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy
Who cannot join
- Comorbidities preventing supine positioning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, University Hospital Heidelberg
Heidelberg, 69120
Maximilian Friedrich, MD, +49 6221 56 37749, maximilian.friedrich@med.uni-heidelberg.de
About this study
The goal of this clinical trial is to learn if a longer period of lying on the back after corneal transplant surgery (Descemet Membrane Endothelial Keratoplasty, DMEK) helps the transplant stick better in the eye. It will also learn about side effects, such as back pain.
The main questions it aims to answer are:
Read more
- Does lying on the back for 5 days reduce the size of transplant detachment compared to lying on the back for only 1 day?
- Do participants who lie on their back longer need fewer additional procedures (rebubbling)?
- What symptoms or problems do participants experience with short vs. long back positioning?
Researchers will compare two groups:
- 1 day of back positioning
- 5 days of back positioning
Participants will:
- Be randomly assigned to one of the two positioning groups
- Wear a movement sensor that records head position
- Have their eyes checked regularly with vision tests and imaging (AS-OCT)
- Answer questions about their vision and comfort
- Keep a diary of any positioning-related complaints, such as back pain
- Being tested
- Duration of Supine Positioning
- 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.
Duration of Supine PositioningProcedure or surgery
1 day supine positioning vs 5 days supine positioning
| Study group | Role | What they receive |
|---|---|---|
| 1 day supine positioning | Experimental | Not described Receives: Procedure: Duration of Supine Positioning |
| 5 day supine positioning | Active comparator | Not described Receives: Procedure: Duration of Supine Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of Graft Detachment in mm²
The area of graft detachment will be measured in mm² using anterior segment optical coherence tomography and a custom-built segmentation tool
Measured: First two postoperative weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start2 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs Endothelial Corneal DystrophyStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian Friedrich, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373821
- Sponsor's protocol ID
- S-400/2025
- Acronym
- SUPINE
- Status last verified
- Jan 2026
- First submitted
- 2 Oct 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)
- ClinicalTrials.gov ID
- NCT07373821
- Acronym / sponsor ID
- SUPINE / S-400/2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Jan 2026 (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.
The goal of this clinical trial is to learn if a longer period of lying on the back after corneal transplant surgery (Descemet Membrane Endothelial Keratoplasty, DMEK) helps the transplant stick better in the eye. It will also learn about side effects, such as back pain.
The main questions it aims to answer are:
- Does lying on the back for 5 days reduce the size of transplant detachment compared to lying on the back for only 1 day?
- Do participants who lie on their back longer need fewer additional procedures (rebubbling)?
- What symptoms or problems do participants experience with short vs. long back positioning?
Researchers will compare two groups:
- 1 day of back positioning
- 5 days of back positioning
Participants will:
- Be randomly assigned to one of the two positioning groups
- Wear a movement sensor that records head position
- Have their eyes checked regularly with vision tests and imaging (AS-OCT)
- Answer questions about their vision and comfort
- Keep a diary of any positioning-related complaints, such as back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 day supine positioning | Experimental | Procedure: Duration of Supine Positioning |
| 5 day supine positioning | Active comparator | Procedure: Duration of Supine Positioning |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy
Key exclusion criteria (1 listed)
- Comorbidities preventing supine positioning
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 |
|---|---|---|
| Duration of Supine Positioning1 day supine positioning vs 5 days supine positioning | Procedure or surgery | 1 day supine positioning, 5 day supine positioning |
Primary outcome
Area of Graft Detachment in mm²
Time frame: First two postoperative weeks
The area of graft detachment will be measured in mm² using anterior segment optical coherence tomography and a custom-built segmentation tool
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duration of Supine Positioning in people with Fuchs Endothelial Corneal Dystrophy and Descemet Membrane Endothelial Keratoplasty (DMEK), run by University Hospital Heidelberg 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maximilian Friedrich, MD (+49 6221 56 37749, maximilian.friedrich@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of Graft Detachment in mm² (time frame: First two postoperative weeks). 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 28 Jan 2026.