Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06013462

DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery

DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months

Status
Recruiting
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREDescemet Membrane Endothelial KeratoplastyDMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation.

Timeline

Start date
2024-03-15
Primary completion
2027-03-14
Completion
2028-04-01
First posted
2023-08-28
Last updated
2025-12-08

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06013462. Inclusion in this directory is not an endorsement.