Fuchs Endothelial Corneal Dystrophy
Conditions
Keywords
Fuchs Endothelial Corneal Dystrophy, Corneal endothelial polishing, Ophtalmic therapeutics
Brief 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. 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.
Interventions
PROCEDUREFuchs Polishing
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.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Pregnant women * Adults under legal protection (guardianship/curatorship) or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the progression of the number of guttata with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the progression of guttae height with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD). | After surgery : Months 1 | The mean height (in µm) of the guttae will be measured using micro-/nanotopography with confocal laser scanning microscopy and interferometry. |
| Compare the removal of corneal endothelial cells with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD) | After surgery : Months 1 | The number of endothelial cells per mm², measured by image analysis after nuclear staining with Hoechst 33342 dye. |
Countries
France
Contacts
CONTACTGilles THURET, MD PhD
CONTACTClara Pfenninger, PhD
PRINCIPAL_INVESTIGATORGilles THURET, MD-PhD
Centre Hospitalo-Universitaire de Saint-Etienne
Outcome results
None listed