NCT07117071

Brief 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. In the absence of available data for France, we analyzed the prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) in a specific sub-population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

August 5, 2025

Last Update Submit

August 5, 2025

Conditions

Keywords

Fuchs endothelial corneal dystrophyspecular microscopyprevalencecarcinoma

Outcome Measures

Primary Outcomes (1)

  • Dark spot in specular microscopy

    Dark sport or guttae after specular microscopy in parallel with the dermatological consultation

    Years: 1

Secondary Outcomes (3)

  • Prevalence of Fuchs endothelial corneal dystrophy (FECD) as a function of age

    Years: 1

  • Prevalence of Fuchs endothelial corneal dystrophy (FECD) as a function of gender

    Years: 1

  • Correlation between Fuchs endothelial corneal dystrophy (FECD) and skin pathology

    Years: 1

Study Arms (1)

screening of Fuchs endothelial corneal dystrophy

Patients with screening of Fuchs endothelial corneal dystrophy will be included.

Other: collection of medical data

Interventions

collection of medical data : Age, Sex, Previous cataract surgery, Cellularity, Dermatological pathology, results of screening of Fuchs endothelial corneal dystrophy by Specular microscopy

screening of Fuchs endothelial corneal dystrophy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with screening of Fuchs endothelial corneal dystrophy will be included.

You may qualify if:

  • Patient with screening of Fuchs endothelial corneal dystrophy

You may not qualify if:

  • Patients under guardianship
  • Patients unable to receive informed consent
  • Patients with anterior segment pathology (declarative) (the eye concerned will not be photographed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Fuchs' Endothelial DystrophyCarcinoma

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Philippe GAIN, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

January 2, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations