NCT07539012

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Mar 2027

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 13, 2026

Last Update Submit

April 20, 2026

Conditions

Fuchs Endothelial Corneal Dystrophy

Keywords

Fuchs Endothelial Corneal DystrophyCorneal endothelial polishingOphtalmic therapeutics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    After surgery : Months 1

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

    After surgery : Months 1

Study Arms (1)

Experimental Group

EXPERIMENTAL
Procedure: Fuchs Polishing

Interventions

Fuchs PolishingPROCEDURE

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.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Saint-Etienne

Saint-Etienne, France, 42055, France

Location

Hopital de Mercy

Metz, Metz, 57085, France

Location

Cochin Hospital

Paris, Paris, 75014, France

Location

Hôpital Fondation Rothschild

Paris, Paris, 75019, France

Location

Centre Hospitalier Universitaire de Rouen

Rouen, Rouen, 76000, France

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gilles THURET, MD-PhD

    Centre Hospitalo-Universitaire de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles THURET, MD PhD

CONTACT

(0)4 77 12 77 96gilles.thuret@univ-st-etienne.fr

Clara Pfenninger, PhD

CONTACT

(0)4 77 12 02 87clara.pfenninger@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

FR(5)