Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fuchs Polishing.
- Who it may be relevant to
- Registry conditions: Fuchs Endothelial Corneal Dystrophy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 polishi
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Compare the progression of guttae height with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD). [Time frame: After surgery : Months 1]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 5 centers
- CHU de Saint-Etienne — Saint-Etienne
- Hopital de Mercy — Metz
- Cochin Hospital — Paris
- Hôpital Fondation Rothschild — Paris
- Centre Hospitalier Universitaire de Rouen — Rouen
Identifiers
NCT: NCT07539012 · 25CH194 · ANSM