An interventional study of Fuchs Polishing in Fuchs Endothelial Corneal Dystrophy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Fuchs 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.
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.
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
Plan to share: Undecided
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