NCT06013462 DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery
| NCT ID | NCT06013462 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2027-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-03-15 with a primary completion date of 2027-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Alain SAAD
PRINCIPAL INVESTIGATOR
Fondation Ophtalmologique A. de Rothschild
Frequently Asked Questions
Who can join the NCT06013462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06013462 currently recruiting?
Yes, NCT06013462 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT06013462 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06013462 clinical trial?
NCT06013462 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The principal investigator is Alain SAAD at Fondation Ophtalmologique A. de Rothschild. The trial plans to enroll 80 participants.