Fuchs Endothelial Corneal DystrophyFuchs PolishinNCT07539012
Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy
A study testing Fuchs Polishing in people with Fuchs Endothelial Corneal Dystrophy, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial summary
Fuchs endothelial corneal dystrophy (FECD) is the leading indication for corneal transplantation worldwide. It is characterized by the accumulation of guttae and progressive loss of corneal endothelial cells, leading to corneal edema and visual impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs Endothelial Corneal Dystrophy
- What is being tested?
- Fuchs Polishing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesFrance
- Study dates
- 21 May 2026to 1 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient affiliated with or entitled to a social security scheme
- Patient scheduled for endothelial keratoplasty for Fuchs endothelial corneal dystrophy
- Patient having received full information and having provided written informed consent
Who cannot join
- Pregnant women
- Adults under legal protection (guardianship/curatorship) or unable to provide informed consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Hopital de Mercy
Metz, Metz, 57085
Jean-Marc Perone, MD, (0)387553426 ext. +33, jean-marc.perone@chr-metz-thionville.fr
- Not yet recruiting
Cochin Hospital
Paris, Paris, 75014
Jean-Louis Bourges, MD-PhD, (0)1 58 41 22 20 ext. +33, jean-louis.bourges@aphp.fr
- Not yet recruiting
Hôpital Fondation Rothschild
Paris, Paris, 75019
Damien Guindolet, MD PhD, (0)6 77 84 77 ext. +33, dguindolet@for.paris
- Not yet recruiting
Centre Hospitalier Universitaire de Rouen
Rouen, Rouen, 76000
Marc Muraine, MD-PhD, (0)2 32 88 80 57 ext. +33, muraine@free.fr
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Gilles THURET, MD-PhD, (0)4 77 12 77 96 ext. +33, gilles.thuret@univ-st-etienne.fr
About this study
Fuchs endothelial corneal dystrophy (FECD) is the leading indication for corneal transplantation worldwide. It is characterized by the accumulation of guttae and progressive loss of corneal endothelial cells, leading to corneal edema and visual impairment. Endothelial keratoplasty remains the standard treatment; however, graft shortages have driven the development of cell-based therapies involving the injection of cultured endothelial cells. A key unresolved issue is whether removal of the pathological endothelium prior to injection improves cell adhesion. Clinical data are limited and sometimes contradictory, particularly regarding endothelial polishing. The actual effectiveness of this procedure in removing guttae and enhancing the survival of injected cells remains uncertain. Therefore, an in vivo clinical evaluation is required to assess its impact on guttae removal.
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Being tested
- Fuchs Polishing
- Keywords
- Fuchs Endothelial Corneal Dystrophy, Corneal endothelial polishing, Ophtalmic therapeutics
- 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.
Fuchs PolishingProcedure or surgery
he study will be offered to all patients for whom corneal transplantation for FECD is indicated at participating centers. After verification of the eligibility criteria, the study will be explained and informed consent will be obtained during the inclusion visit. Only one follow-up visit is planned, on the day of surgery. During the procedure, polishing of one half of the pathological endothelium will be performed prior to its removal and replacement with healthy donor endothelium (Fuchs polishing). The excised pathological endothelium will be sent to the laboratory for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Procedure: Fuchs Polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the progression of the number of guttata with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy
Comparison of the number of guttae per unit area (guttae/mm²) between the polished half of the sample and the untreated half. Measurement performed by image analysis after capturing the entire surface of the pathological endothelium removed by Descemetorhexis in FECD patients.
Measured: After surgery : Months 1
Secondary outcomes (2)
Compare the progression of guttae height with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD).
The mean height (in µm) of the guttae will be measured using micro-/nanotopography with confocal laser scanning microscopy and interferometry.
Measured: After surgery : Months 1
Compare the removal of corneal endothelial cells with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD)
The number of endothelial cells per mm², measured by image analysis after nuclear staining with Hoechst 33342 dye.
Measured: After surgery : Months 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start21 May 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles THURET, MD-PhD, Principal investigator, Centre Hospitalo-Universitaire de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539012
- Sponsor's protocol ID
- 25CH194
- Other IDs
- ANSM
- Acronym
- Fuchs Polishin
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy
- ClinicalTrials.gov ID
- NCT07539012
- Acronym / sponsor ID
- Fuchs Polishin / 25CH194
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Keywords
- Fuchs Endothelial Corneal Dystrophy, Corneal endothelial polishing, Ophtalmic therapeutics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Apr 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.
Fuchs endothelial corneal dystrophy (FECD) is the leading indication for corneal transplantation worldwide. It is characterized by the accumulation of guttae and progressive loss of corneal endothelial cells, leading to corneal edema and visual impairment. Endothelial keratoplasty remains the standard treatment; however, graft shortages have driven the development of cell-based therapies involving the injection of cultured endothelial cells. A key unresolved issue is whether removal of the pathological endothelium prior to injection improves cell adhesion. Clinical data are limited and sometimes contradictory, particularly regarding endothelial polishing. The actual effectiveness of this procedure in removing guttae and enhancing the survival of injected cells remains uncertain. Therefore, an in vivo clinical evaluation is required to assess its impact on guttae removal.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Fuchs Polishing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient affiliated with or entitled to a social security scheme
- Patient scheduled for endothelial keratoplasty for Fuchs endothelial corneal dystrophy
- Patient having received full information and having provided written informed consent
Key exclusion criteria (2 listed)
- Pregnant women
- Adults under legal protection (guardianship/curatorship) or unable to provide informed consent
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 |
|---|---|---|
| Fuchs Polishinghe study will be offered to all patients for whom corneal transplantation for FECD is indicated at participating centers. After verification of the eligibility criteria, the study will be explained and informed consent will be obtained during the inclusion visit. Only one follow-up visit is planned, on the day of surgery. During the procedure, polishing of one half of the pathological endothelium will be performed prior to its removal and replacement with healthy donor endothelium (Fuchs polishing). The excised pathological endothelium will be sent to the laboratory for analysis. | Procedure or surgery | Experimental Group |
Primary outcome
Compare the progression of the number of guttata with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy
Time frame: After surgery : Months 1
Comparison of the number of guttae per unit area (guttae/mm²) between the polished half of the sample and the untreated half. Measurement performed by image analysis after capturing the entire surface of the pathological endothelium removed by Descemetorhexis in FECD patients.
2 secondary outcomes
Compare the progression of guttae height with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD).
Time frame: After surgery : Months 1
Compare the removal of corneal endothelial cells with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD)
Time frame: After surgery : Months 1
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 26 May 2026.
- Individual participant dataSharing planned: Undecided
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.
Gilles THURET, MD-PhD principal investigator
Centre Hospitalo-Universitaire de Saint-Etienne
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fuchs Polishing in people with Fuchs Endothelial Corneal Dystrophy, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites 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 3 inclusion and 2 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Gilles THURET, MD PhD ((0)4 77 12 77 96 ext. +33, gilles.thuret@univ-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the progression of the number of guttata with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (time frame: After surgery : Months 1). 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 26 May 2026.