Status:
RECRUITING
DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Conditions:
Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery
Eligibility:
All Genders
18+ years
Brief Summary
DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation. At the Rothschild Foundation, as in many Western referr...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Patients scheduled for corneal endothelial transplantation in one or both eyes
- History of vitrectomy, trabeculectomy, large iris defects, anterior synechiae on the eye to be operated on
- Pseudophakia or aphakia in the eye to be operated on
- Express consent to participate in the study
- Affiliated or beneficiary of a social security scheme
- Exclusion Criteria :
- Need for combined PKE + EK surgery
- Primary endothelial decompensation
- At least one contraindication to endothelial transplantation :
- Presence of a stromal corneal cleft
- Inflammatory or degenerative corneal pathology other than endothelial
- Progressive corneal infection
- Degenerative retinal pathology not allowing visual recovery postoperatively (for the purposes of this study, we accept patients who have had retinal detachment and whose loss of vision is clearly attributable to endothelial decompensation)
- End-stage glaucoma not allowing visual recovery post-operatively (for this study, we accept patients who have had filtering surgery for glaucoma, which is stabilized at the time of surgery. Decline in vision must be clearly attributable to endothelial decompensation)
- Medical contraindication to general or local anesthesia
- Patient under legal protection
- Pregnant or breast-feeding women
Exclusion
Key Trial Info
Start Date :
March 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06013462
Start Date
March 15 2024
End Date
April 1 2028
Last Update
December 8 2025
Active Locations (1)
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1
Fondation Ophtalmologique A de Rothschild
Paris, France, 75019