Fuchs Endothelial Corneal DystrophyNCT04387331
The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK
An observational study of Fuchs Endothelial Corneal Dystrophy and Pseudophakic Bullous Keratopathy, run by Peter Wiedemann at 1 site in Germany.
Trial summary
This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Chemical Burn of Cornea
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2020to Jun 2021
- Phase
- Observational
- 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
Study population: All patients with Descemet Membrane Endothelial Keratoplasty during the study are offered to participate.
Who may be able to join
- all patients undergoing DMEK
Who cannot join
- no specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
Louise Kühne contact
Germany1 site, 1 recruiting
- Recruiting
Leipzig University Hospital, Department of Ophthalmology
Leipzig, Saxony, 04103
Christian Girbardt, MD, 00493419721668, christian.girbardt@medizin.uni-leipzig.de
Louise Kühne, louise.kuehne@medizin.uni-leipzig.de
About this study
This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.
Read the detailed description
After Descemet Membrane Endothelial Keratoplasty (DMEK) patients are recommended to keep a strict supine position within the first few days after surgery in order to attach the graft to the corneal stroma. It has not yet been investigated to what extent the head position actually has an effect on the outcome.
In this study, the participants head position will be continuously monitored within the first three days after DMEK. Participants wear a headband in which a small sensor is inserted. The degree of deviation from the neutral position will then be correlated with clinical outcomes.
- Conditions
- Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Chemical Burn of Cornea, Posterior Polymorphous Corneal Dystrophy
- Keywords
- Descemet Membrane Endothelial Keratoplasty, DMEK, Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Chemical Burn of Cornea, Posterior Polymorphous Corneal Dystrophy, Postoperative Head Position, Corneal Transplantation, Head Tracking Sensor
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Corneal Dystrophy, Posterior Polymorphous, 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Endothelial Cell Density
measured in cells/mm2
Measured: three months after surgery
Secondary outcomes (4)
Best Corrected Visual Acuity
measured in logMAR
Measured: prior to surgery, three and six months after surgery
Central Corneal Thickness
measured in μm
Measured: prior to surgery, three and six months after surgery
Number of Re-Bubblings
need of surgical intervention after DMEK in order to attach the graft
Measured: six months after surgery
Corneal Endothelial Density
measured in cells/mm"
Measured: six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start11 May 2020
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Wiedemann
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Angewandte Trainingswissenschaft
- Responsible party
- Sponsor-investigator, Peter Wiedemann, University of Leipzig
- Investigators
- Peter Wiedemann, MD, Study director, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387331
- Sponsor's protocol ID
- 287/19-ek
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK
- ClinicalTrials.gov ID
- NCT04387331
- Acronym / sponsor ID
- 287/19-ek
- Conditions
- Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Chemical Burn of Cornea, Posterior Polymorphous Corneal Dystrophy
- Keywords
- Descemet Membrane Endothelial Keratoplasty, DMEK, Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Chemical Burn of Cornea, Posterior Polymorphous Corneal Dystrophy, Postoperative Head Position, Corneal Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peter WiedemannUniversity, hospital or other
- Collaborators
- Institut für Angewandte Trainingswissenschaft
- Study start
- 11 May 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 May 2020 (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 study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.
Detailed description
After Descemet Membrane Endothelial Keratoplasty (DMEK) patients are recommended to keep a strict supine position within the first few days after surgery in order to attach the graft to the corneal stroma. It has not yet been investigated to what extent the head position actually has an effect on the outcome.
In this study, the participants head position will be continuously monitored within the first three days after DMEK. Participants wear a headband in which a small sensor is inserted. The degree of deviation from the neutral position will then be correlated with clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with Descemet Membrane Endothelial Keratoplasty during the study are offered to participate.
Key inclusion criteria (1 listed)
- all patients undergoing DMEK
Key exclusion criteria (1 listed)
- no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corneal Endothelial Cell Density
Time frame: three months after surgery
measured in cells/mm2
4 secondary outcomes
Best Corrected Visual Acuity
Time frame: prior to surgery, three and six months after surgery
Central Corneal Thickness
Time frame: prior to surgery, three and six months after surgery
Number of Re-Bubblings
Time frame: six months after surgery
Corneal Endothelial Density
Time frame: six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
Related trials for Fuchs Endothelial Corneal 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.
Louise Kühne contact
Peter Wiedemann, MD study director
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fuchs Endothelial Corneal Dystrophy and Pseudophakic Bullous Keratopathy, run by Peter Wiedemann 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: status not confirmed, as of the sponsor's last update on 13 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Girbardt, MD (00493419721668, christian.girbardt@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Endothelial Cell Density (time frame: three months after surgery). 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 13 May 2020.