Surgery for corneal issues in patients with previous eye surgeries
DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months
This study looks at how well a specific eye surgery called DMEK works for patients who have had other eye surgeries before and if they face more risks during the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT06013462 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) who have a history of anterior or posterior segment surgeries. DMEK is a complex surgical technique aimed at treating corneal endothelial decompensation, which can occur due to various eye conditions. The study aims to assess the outcomes and complication rates of DMEK in patients with specific prior surgical histories, as these patients may face higher risks compared to those without such histories. The research will provide insights into the effectiveness and safety of DMEK in this unique patient population.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for corneal endothelial transplantation who have a history of specific eye surgeries such as vitrectomy or trabeculectomy.
Not a fit: Patients requiring combined surgeries or those with primary endothelial decompensation or other contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and reduce complications for patients with complex eye histories undergoing DMEK.
How similar studies have performed: While DMEK has shown success in general populations, this specific focus on patients with prior surgeries is less explored, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Fondation Ophtalmologique A de Rothschild — Paris, France (Recruiting)
Study contacts
- Principal investigator: Alain SAAD — Fondation Ophtalmologique A. de Rothschild
- Study coordinator: Amélie YAVCHITZ
- Email: ayavchitz@for.paris
- Phone: 01.48.03.64.33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.