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

NCT06013462 | Recruiting

• 1 other identifier: ASD_2023_6
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery

Outcome Measures

Primary Outcomes (1)

• Occurrence rate of at least one serious DMEK post-op complication

  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).

  12 months

Secondary Outcomes (28)

• Rebulling occurrence rate

  12 months

• Graft failure occurrence rate

  12 months

• Graft rejection occurrence rate

  12 months

• Macular cystoid edema occurrence rate

  12 months

• Intraocular hypertension occurrence rate

  12 months

Interventions

Descemet Membrane Endothelial Keratoplasty PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group of 80 patients admitted for consultation at the Hôpital Fondation Adolphe de Rothschild up to one year prior to endothelial transplantation and meeting the above eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

RECRUITING

Study Officials

• Alain SAAD

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie YAVCHITZ

CONTACT

01.48.03.64.33; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: March 15, 2024
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

FR (1)