Surgery for corneal issues in patients with previous eye surgeries
Official title: DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months
Run by Fondation Ophtalmologique Adolphe de Rothschild · NCT06013462 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | March 15, 2024 |
| Main results expected | March 14, 2027 |
| Study ends | April 2028 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT06013462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients scheduled for corneal endothelial transplantation who have a history of specific eye surgeries such as vitrectomy or trabeculectomy.
✕Probably not a fit
Patients requiring combined surgeries or those with primary endothelial decompensation or other contraindications will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While DMEK has shown success in general populations, this specific focus on patients with prior surgeries is less explored, making it a novel approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
French validation of the SAHOT outcome tool after subarachnoid hemorrhage
This study tests whether a French version of the SAHOT questionnaire reliably measures outcomes in adults after subarachnoid hemorrhage.
-
Blood RNA biomarkers for ALS using neuron-derived extracellular vesicles
This will try to see if RNA signatures in neuron-derived extracellular vesicles from blood can identify biomarkers in adults with suspected sporadic ALS compared with healthy volunteers.
-
Probenecid for cluster seizures during presurgical epilepsy monitoring
This trial tests whether probenecid can help control clusters of seizures in people with focal epilepsy during presurgical video-EEG monitoring.
-
Onset of myopia in children who are not yet myopic
This study follows children aged 4 to under 9 with no myopia to see how many become nearsighted over time and what factors might influence that shift.
-
Using virtual reality to measure progress during low vision rehabilitation
This project will test a 20-minute virtual reality test (VisionumVR on a Meta Quest 3) to measure functional vision in people with low vision who are starting or undergoing orthoptic rehabilitation.
-
Renal Involvement in Wilson's Disease
This study tests how Wilson's disease affects the kidneys and who might be at risk for kidney problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.