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NCT Number: NCT07539012

Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy

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.

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Key information

Conditions

Fuchs Endothelial Corneal Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne, Saint-Etienne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fuchs Polishing

Procedure

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.

Primary outcomes

  1. Compare the progression of the number of guttata with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy

    Time frame: 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 outcomes

  1. Compare the progression of guttae height with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD).

    Time frame: 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.

  2. Compare the removal of corneal endothelial cells with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD)

    Time frame: After surgery : Months 1

    The number of endothelial cells per mm², measured by image analysis after nuclear staining with Hoechst 33342 dye.

Study contacts

Contact information is provided by the study sponsor or research team.

Clara Pfenninger, PhD

CONTACT

[email protected]

(0)4 77 12 02 87 ext. +33

Gilles THURET, MD PhD

CONTACT

[email protected]

(0)4 77 12 77 96 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: Fuchs Polishin

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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