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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
CHU de Saint-Etienne
Saint-Etienne, France, France
RECRUITINGHopital de Mercy
Metz, Metz, France
NOT_YET_RECRUITINGCochin Hospital
Paris, Paris, France
NOT_YET_RECRUITINGHôpital Fondation Rothschild
Paris, Paris, France
NOT_YET_RECRUITINGCentre Hospitalier Universitaire de Rouen
Rouen, Rouen, France
NOT_YET_RECRUITINGCompare 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.
Time frame: After surgery : Months 1
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.
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)
The number of endothelial cells per mm², measured by image analysis after nuclear staining with Hoechst 33342 dye.
Time frame: After surgery : Months 1
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