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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery
• Intervention / Treatment: Procedure: Descemet Membrane Endothelial Keratoplasty

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Amélie YAVCHITZ; Phone Number: +33 01.48.03.64.33; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Fondation Ophtalmologique A de Rothschild
    • Contact: Alain Saad
    • Contact: Email: asaad@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebulling occurrence rate	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.	12 months
Graft failure occurrence rate	No improvement in pachymetry at three months post-op (Avanti OCT-cornea).	12 months
Graft rejection occurrence rate	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).	12 months
Macular cystoid edema occurrence rate	Presence of intraretinal fluid in the macular area (macular OCT).	12 months
Intraocular hypertension occurrence rate	Intraocular pressure greater than 21mmHg measured by pneumotonometer or applanation tonometer.	12 months
Graft detachment (with or without rebulling) occurrence rate	Failure of the graft to press against the posterior host corneal stroma (Avanti OCT-cornea and slit-lamp biomicroscopic examination).	12 months
Surgeon's subjective assessment of surgical complexity	Evaluation by the main surgeon at the end of the procedure, on a Likert scale from 0 to 10 (0 being normal, uncomplicated surgery and 10 being the maximum level of complexity encountered).	Right after the completion of the surgery
Duration of surgical procedure (in minutes)	The start of the procedure is defined by the placement of the blepharostat and the end of the procedure is defined by the end of the lens dressing.	Right after the completion of the surgery
Evolution of endothelial loss	Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.	1 month after surgery
Evolution of endothelial loss	Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.	3 months after surgery
Evolution of endothelial loss	Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.	6 months after surgery
Evolution of endothelial loss	Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.	12 months after surgery
Evolution of corneal thickness	Corneal thickness in μm measured by OCT - Avanti® type cornea.	1 month after surgery
Evolution of corneal thickness	Corneal thickness in μm measured by OCT - Avanti® type cornea.	3 months after surgery
Evolution of corneal thickness	Corneal thickness in μm measured by OCT - Avanti® type cornea.	6 months after surgery
Evolution of corneal thickness	Corneal thickness in μm measured by OCT - Avanti® type cornea.	12 months after surgery
Evolution of posterior keratometry	Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).	1 month after surgery
Evolution of posterior keratometry	Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).	3 months after surgery
Evolution of posterior keratometry	Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).	6 months after surgery
Evolution of posterior keratometry	Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).	12 months after surgery
Evolution of visual results (corrected and uncorrected)	Measurements with optotypes : Best monocular visual acuity (decimal scale converted to logMAR)	1 month after surgery
Evolution of visual results (corrected and uncorrected)	Measurements with optotypes : Best monocular visual acuity (decimal scale converted to logMAR)	3 months after surgery
Evolution of visual results (corrected and uncorrected)	Measurements with optotypes : Best monocular visual acuity (decimal scale converted to logMAR)	6 months after surgery
Evolution of visual results (corrected and uncorrected)	Measurements with optotypes : Best monocular visual acuity (decimal scale converted to logMAR)	12 months after surgery
Evolution of refractive results	Nidek® autorefractometer measurement : Sphere (in dioptres); Cylinder (in dioptres); Spherical equivalent (in dioptres); Cylinder axis (in degrees)	1 month after surgery
Evolution of refractive results	Nidek® autorefractometer measurement : Sphere (in dioptres); Cylinder (in dioptres); Spherical equivalent (in dioptres); Cylinder axis (in degrees)	3 months after surgery
Evolution of refractive results	Nidek® autorefractometer measurement : Sphere (in dioptres); Cylinder (in dioptres); Spherical equivalent (in dioptres); Cylinder axis (in degrees)	6 months after surgery
Evolution of refractive results	Nidek® autorefractometer measurement : Sphere (in dioptres); Cylinder (in dioptres); Spherical equivalent (in dioptres); Cylinder axis (in degrees)	12 months after surgery

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Alain SAAD, Fondation Ophtalmologique A. De Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ASD_2023_6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No