Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy (Fuchs Polishin)

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 Overview

• Status: Recruiting
• Conditions: Fuchs Endothelial Corneal Dystrophy
• Intervention / Treatment: Procedure: Fuchs Polishing

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilles THURET, MD PhD; Phone Number: +33 (0)4 77 12 77 96; Email: gilles.thuret@univ-st-etienne.fr
• Study Contact Backup: Name: Clara Pfenninger, PhD; Phone Number: +33 (0)4 77 12 02 87; Email: clara.pfenninger@chu-st-etienne.fr

Study Locations

• France
  • France
    • Saint-Etienne, France, France, 42055
      • Recruiting
      • CHU de Saint-Etienne
      • Contact: Gilles THURET, MD-PhD; Phone Number: +33 (0)4 77 12 77 96; Email: gilles.thuret@univ-st-etienne.fr
  • Metz
    • Metz, Metz, France, 57085
      • Not yet recruiting
      • Hopital de Mercy
      • Contact: Jean-Marc Perone, MD; Phone Number: +33 (0)387553426; Email: jean-marc.perone@chr-metz-thionville.fr
  • Paris
    • Paris, Paris, France, 75014
      • Not yet recruiting
      • Cochin Hospital
      • Contact: Jean-Louis Bourges, MD-PhD; Phone Number: +33 (0)1 58 41 22 20; Email: jean-louis.bourges@aphp.fr
    • Paris, Paris, France, 75019
      • Not yet recruiting
      • Hôpital Fondation Rothschild
      • Contact: Damien Guindolet, MD PhD; Phone Number: +33 (0)6 77 84 77; Email: dguindolet@for.paris
  • Rouen
    • Rouen, Rouen, France, 76000
      • Not yet recruiting
      • Centre Hospitalier Universitaire de Rouen
      • Contact: Marc Muraine, MD-PhD; Phone Number: +33 (0)2 32 88 80 57; Email: muraine@free.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental Group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After surgery : Months 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	After surgery : Months 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Gilles THURET, MD-PhD, Centre Hospitalo-Universitaire de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Fuchs Endothelial Corneal Dystrophy; Corneal endothelial polishing; Ophtalmic therapeutics
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Eye Diseases; Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases, Hereditary; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 25CH194; ANSM (Other Identifier: 2025-A02921-48)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No