Fuchs' Endothelial Corneal DystrophyCORNEACOHORTNCT06859411
Prognosis of Posterior Lamellar Keratoplasty
An observational study of Fuchs' Endothelial Corneal Dystrophy and Pseudophakic Bullous Keratopathy, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Over the past decade, the management of Fuchs' endothelial corneal dystrophy (FECD) and pseudophakic bullous keratopathy (PBK) has been revolutionized by the development of posterior lamellar keratoplasty techniques: DSAEK and DMEK. 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
- What is being tested?
- visual acuity comparaison
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to 1 Jan 2040
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients who received a posterior lamellar keratoplasty
Who may be able to join
- patients who received a posterior lamellar keratoplasty in Metz-Thionville Regional Hospital between 2012 and 2030
Who cannot join
- patients refusing to take part in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR Metz-Thionville Hopital de Mercy
Metz, 57085
Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr
Jean-Marc PERONE, MD
About this study
Official title: Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study
Over the past decade, the management of Fuchs' endothelial corneal dystrophy (FECD) and pseudophakic bullous keratopathy (PBK) has been revolutionized by the development of posterior lamellar keratoplasty techniques: DSAEK and DMEK.
DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's endothelium and pathological descemetum with a descemetic endothelial graft combined with a thin stromal lamella. The endothelial density of the grafts is generally greater than 2,400 cells/mm². Depending on the grafting center and tissue bank, grafts may be either pre-cut in the tissue bank or cut on the operating table by the surgeon himself.
Read more
The donor graft is placed on an artificial anterior chamber, and automated microkeratome cutting produces grafts with an average thickness of 100 to 200µm, sometimes less than 100um (known as UT-DSAEK or ultra-thin DSAEK).
DMEK (Descemet Membrane Endothelial Keratoplasty) is a strictly endothelium and Descemet's membrane graft, as close as possible to the original anatomy of the cornea. The graft is dissected manually either in a tissue bank (pre-cut grafts) or on the operating table by the surgeon. The thickness of the graft is between 15 and 18 microns.
The primary objective of this observational cohort is to compare the evolution of visual acuity after DMEK, DSAEK or UT-DSAEK transplantation.
Secondary objectives are to compare the evolution of endothelial cell density, corneal thickness and early and late post-operative complications, and to identify factors predictive of these different endpoints.
- Being tested
- visual acuity comparaison
- Keywords
- posterior lamellar keratoplasty, cornea, DMEK, DSAEK
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual acuity comparaisonProcedure or surgery
Data collection
| Study group | Role | What they receive |
|---|---|---|
| DMEK | Patients who received Descemet Membrane Endothelial Keratoplasty Receives: Procedure: visual acuity comparaison | |
| DSAEK | Patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thicker than 160 µm Receives: Procedure: visual acuity comparaison | |
| UT-DSAEK | DSAEK: patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thinner than 160 µm Receives: Procedure: visual acuity comparaison |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSCVA
best spectacle-corrected visual acuity (logMAR)
Measured: at 1 year after surgery, but also at day 8, day 15, 1 month, 3 months, 6 months and every year up to 10 years after surgery
Secondary outcomes (3)
ECD
endothelial cell count (cells/mm²)
Measured: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
CCT
central cornea thickness (µm)
Measured: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
post-operative complication
graft reject (yes/no), graft detachment (yes/no), graft failure (yes/no), eye infection (yes/no)
Measured: up to 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Jun 2024
- Primary completion1 Jan 2040 (estimated)
- Study completion1 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc PERONE, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859411
- Sponsor's protocol ID
- 2024-11Obs-CHRMT
- Acronym
- CORNEACOHORT
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No According to French law and the French Data Protection Authority (CNIL), the investigators will not be able to publicly share individual participant data; however, the investigators plan to share the conclusions through peer-reviewed publications and conferences.
Publications
Delean S, Goetz C, Zevering Y, Perone JM. Central Corneal Thickness 6 Postoperative Months After Pseudophakic-Descemet Membrane Endothelial Keratoplasty, Triple-Descemet Membrane Endothelial Keratoplasty, and Cataract Surgery Alone: A Retrospective Cohort Study and Literature Review. Cornea. 2026 Mar 11. doi: 10.1097/ICO.0000000000004144. Online ahead of print.
PubMed 41921039
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06859411
- Acronym / sponsor ID
- CORNEACOHORT / 2024-11Obs-CHRMT
- Keywords
- posterior lamellar keratoplasty, cornea, DMEK, DSAEK
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2040 (estimated)
- Study completion
- 1 Jan 2040 (estimated)
- First posted
- 5 Mar 2025 (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.
Over the past decade, the management of Fuchs' endothelial corneal dystrophy (FECD) and pseudophakic bullous keratopathy (PBK) has been revolutionized by the development of posterior lamellar keratoplasty techniques: DSAEK and DMEK.
DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's endothelium and pathological descemetum with a descemetic endothelial graft combined with a thin stromal lamella. The endothelial density of the grafts is generally greater than 2,400 cells/mm². Depending on the grafting center and tissue bank, grafts may be either pre-cut in the tissue bank or cut on the operating table by the surgeon himself.
The donor graft is placed on an artificial anterior chamber, and automated microkeratome cutting produces grafts with an average thickness of 100 to 200µm, sometimes less than 100um (known as UT-DSAEK or ultra-thin DSAEK).
DMEK (Descemet Membrane Endothelial Keratoplasty) is a strictly endothelium and Descemet's membrane graft, as close as possible to the original anatomy of the cornea. The graft is dissected manually either in a tissue bank (pre-cut grafts) or on the operating table by the surgeon. The thickness of the graft is between 15 and 18 microns.
The primary objective of this observational cohort is to compare the evolution of visual acuity after DMEK, DSAEK or UT-DSAEK transplantation.
Secondary objectives are to compare the evolution of endothelial cell density, corneal thickness and early and late post-operative complications, and to identify factors predictive of these different endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DMEK | – | Procedure: visual acuity comparaisonPatients who received Descemet Membrane Endothelial Keratoplasty |
| DSAEK | – | Procedure: visual acuity comparaisonPatients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thicker than 160 µm |
| UT-DSAEK | – | Procedure: visual acuity comparaisonDSAEK: patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thinner than 160 µm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who received a posterior lamellar keratoplasty
Key inclusion criteria (1 listed)
- patients who received a posterior lamellar keratoplasty in Metz-Thionville Regional Hospital between 2012 and 2030
Key exclusion criteria (1 listed)
- patients refusing to take part in the study
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 |
|---|---|---|
| visual acuity comparaisonData collection | Procedure or surgery | DMEK, DSAEK, UT-DSAEK |
Primary outcome
BSCVA
Time frame: at 1 year after surgery, but also at day 8, day 15, 1 month, 3 months, 6 months and every year up to 10 years after surgery
best spectacle-corrected visual acuity (logMAR)
3 secondary outcomes
ECD
Time frame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
CCT
Time frame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
post-operative complication
Time frame: up to 10 years after surgery
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 24 Jun 2026.
- Derived from this study: PubMed 41921039Delean S, Goetz C, Zevering Y, Perone JM. Central Corneal Thickness 6 Postoperative Months After Pseudophakic-Descemet Membrane Endothelial Keratoplasty, Triple-Descemet Membrane Endothelial Keratoplasty, and Cataract Surgery Alone: A Retrospective Cohort Study and Literature Review. Cornea. 2026 Mar 11. doi: 10.1097/ICO.0000000000004144. Online ahead of print.
- Individual participant dataSharing planned: No. No According to French law and the French Data Protection Authority (CNIL), the investigators will not be able to publicly share individual participant data; however, the investigators plan to share the conclusions through peer-reviewed publications and conferences.
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.
Jean-Marc PERONE, MD principal investigator
CHR Metz Thionville Hopital de Mercy
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 Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 24 Jun 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 France. 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 Arpiné EL NAR, PhD (0033387557766, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSCVA (time frame: at 1 year after surgery, but also at day 8, day 15, 1 month, 3 months, 6 months and every year up to 10 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06859411, which also lists 1 linked publication.
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 24 Jun 2026.