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RECRUITING
NCT07539012
NA

Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-21

Completion Date

2027-03-01

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

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.

Locations (5)

CHU de Saint-Etienne

Saint-Etienne, France, France

Hopital de Mercy

Metz, Metz, France

Cochin Hospital

Paris, Paris, France

Hôpital Fondation Rothschild

Paris, Paris, France

Centre Hospitalier Universitaire de Rouen

Rouen, Rouen, France