Informations générales (source: ClinicalTrials.gov)
DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months (DMEK complexes)
Observational
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
mars 2024
avril 2028
23 mai 2025
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 referral centers, DMEK is currently the surgical technique of choice for
the treatment of primary or secondary corneal endothelial decompensation.
Technically challenging, it is a relatively tedious surgery to learn, but offers the best
visual and refractive results, as well as faster visual and functional recovery in simple
cases.
In patients without anterior or posterior segment surgical history, the complication rate
of DMEK, including graft rejection, is similar to that of other endothelial keratoplasty
surgical techniques.
However, in specific cases, in patients with a history of ophthalmological surgery such
as vitrectomy, trabeculectomy, large iris defects, anterior synechiae, aniridia or
aphakia, the scientific literature shows a higher complication rate for DMEK (increased
rate of rebulling and graft decompensation).
As a result, other techniques that are less effective on visual results continue to be
used for these patients in a large number of centers.
Nonetheless, in our department, DMEK is also performed on these complicated patients.
When it comes to patients with a history of anterior or posterior segment surgery, it
seems to us that the surgeons' experience with DMEK allows better visual results than
with any other technique, but without any back up regarding the complication rate in the
literature.
The main aim of this study is to describe, in patients with a history of anterior or
posterior segment surgery undergoing DMEK, the 12-months occurrence rate of at least one
serious post-operative complication.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Alain SAAD | 21/06/2024 13:35:13 | Contacter | ||
Critères
Tous
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
- 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