Fuchs Endothelial Corneal DystrophyNCT07117071
Prevalence of Fuchs Endothelial Corneal Dystrophy in a Population of Dermatology Patients.
An observational study of Fuchs Endothelial Corneal Dystrophy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) varies from 3.7 to 21.6% of adults depending on the population studied (country and age class), the method of diagnosis and the definition adopted. 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?
- collection of medical data
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2024to 31 Dec 2024
- 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: Patient with screening of Fuchs endothelial corneal dystrophy will be included.
Who may be able to join
- Patient with screening of Fuchs endothelial corneal dystrophy
Who cannot join
- Patients under guardianship
- Patients unable to receive informed consent
- Patients with anterior segment pathology (declarative) (the eye concerned will not be photographed)
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) varies from 3.7 to 21.6% of adults depending on the population studied (country and age class), the method of diagnosis and the definition adopted. In the absence of available data for France, we analyzed the prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) in a specific sub-population.
Read the detailed description
The Primary purpose is to Estimate the prevalence of Fuchs' endothelial dystrophy in the French population in dermatology population.
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Being tested
- collection of medical data
- Keywords
- Fuchs endothelial corneal dystrophy, specular microscopy, prevalence, carcinoma
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of medical dataOther
collection of medical data : Age, Sex, Previous cataract surgery, Cellularity, Dermatological pathology, results of screening of Fuchs endothelial corneal dystrophy by Specular microscopy
| Study group | Role | What they receive |
|---|---|---|
| screening of Fuchs endothelial corneal dystrophy | Patients with screening of Fuchs endothelial corneal dystrophy will be included. Receives: Other: collection of medical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dark spot in specular microscopy
Dark sport or guttae after specular microscopy in parallel with the dermatological consultation
Measured: Years: 1
Secondary outcomes (3)
Prevalence of Fuchs endothelial corneal dystrophy (FECD) as a function of age
Prevalence of Fuchs endothelial corneal dystrophy (FECD) as a function of age. Data of medical record will be analyzed.
Measured: Years: 1
Prevalence of Fuchs endothelial corneal dystrophy (FECD) as a function of gender
Prevalence of Fuchs endothelial corneal dystrophy (FECD) as a function of gender.
Data of medical record will be analyzed.
Measured: Years: 1
Correlation between Fuchs endothelial corneal dystrophy (FECD) and skin pathology
Correlation between Fuchs endothelial corneal dystrophy (FECD) and skin pathology.
Data of medical record will be analyzed.
Measured: Years: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start2 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe GAIN, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117071
- Sponsor's protocol ID
- IRBN1392025/CHUSTE
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Fuchs Endothelial Corneal Dystrophy in a Population of Dermatology Patients.
- ClinicalTrials.gov ID
- NCT07117071
- Acronym / sponsor ID
- IRBN1392025/CHUSTE
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Keywords
- Fuchs endothelial corneal dystrophy, specular microscopy, prevalence, carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Aug 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.
The prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) varies from 3.7 to 21.6% of adults depending on the population studied (country and age class), the method of diagnosis and the definition adopted. In the absence of available data for France, we analyzed the prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) in a specific sub-population.
Detailed description
The Primary purpose is to Estimate the prevalence of Fuchs' endothelial dystrophy in the French population in dermatology population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening of Fuchs endothelial corneal dystrophy | – | Other: collection of medical dataPatients with screening of Fuchs endothelial corneal dystrophy will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with screening of Fuchs endothelial corneal dystrophy will be included.
Key inclusion criteria (1 listed)
- Patient with screening of Fuchs endothelial corneal dystrophy
Key exclusion criteria (3 listed)
- Patients under guardianship
- Patients unable to receive informed consent
- Patients with anterior segment pathology (declarative) (the eye concerned will not be photographed)
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 |
|---|---|---|
| collection of medical datacollection of medical data : Age, Sex, Previous cataract surgery, Cellularity, Dermatological pathology, results of screening of Fuchs endothelial corneal dystrophy by Specular microscopy | Other | screening of Fuchs endothelial corneal dystrophy |
Primary outcome
Dark spot in specular microscopy
Time frame: Years: 1
Dark sport or guttae after specular microscopy in parallel with the dermatological consultation
3 secondary outcomes
Prevalence of Fuchs endothelial corneal dystrophy (FECD) as a function of age
Time frame: Years: 1
Prevalence of Fuchs endothelial corneal dystrophy (FECD) as a function of gender
Time frame: Years: 1
Correlation between Fuchs endothelial corneal dystrophy (FECD) and skin pathology
Time frame: Years: 1
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 12 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Fuchs Endothelial Corneal Dystrophy
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Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
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Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
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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. This study is not recruiting at the moment.
Philippe GAIN, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 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 12 Aug 2025. 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?
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?
Dark spot in specular microscopy (time frame: Years: 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 12 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.