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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Occurrence rate of at least one serious DMEK post-op complication — 12 months
  Composite endpoint made of 4 serious post-op complications : * Rebulling : graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber. * Graft failure : no improvement in pachymetry at three months post-op (Avanti OCT-cornea). * Graft rejection : presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry \> 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination). * Macular cystoid edema : presence of intraretinal fluid in the macular area (macular OCT).

Trial sites (1)

More Fondation Ophtalmologique Adolphe de Rothschild trials in France