RecruitingNot ApplicableNCT07539012

Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

20 participants

Start Date

May 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • Pregnant women
  • Adults under legal protection (guardianship/curatorship) or unable to provide informed consent

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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.


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

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NCT07539012


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