Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant women

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Fuchs Polishing

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
After surgery : Months 1

Secondary outcomes

1

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.

Time frame
After surgery : Months 1
2

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.

Time frame
After surgery : Months 1

Other outcomes

Sponsors and contacts

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