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NCT Number: NCT06013462

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location status: Recruiting

Location contact

Alain SAAD

CONTACT

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Descemet Membrane Endothelial Keratoplasty

Procedure

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

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Rebulling occurrence rate

    Time frame: 12 months

    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.

  2. Graft failure occurrence rate

    Time frame: 12 months

    No improvement in pachymetry at three months post-op (Avanti OCT-cornea).

  3. Graft rejection occurrence rate

    Time frame: 12 months

    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).

  4. Macular cystoid edema occurrence rate

    Time frame: 12 months

    Presence of intraretinal fluid in the macular area (macular OCT).

  5. Intraocular hypertension occurrence rate

    Time frame: 12 months

    Intraocular pressure greater than 21mmHg measured by pneumotonometer or applanation tonometer.

  6. Graft detachment (with or without rebulling) occurrence rate

    Time frame: 12 months

    Failure of the graft to press against the posterior host corneal stroma (Avanti OCT-cornea and slit-lamp biomicroscopic examination).

  7. Surgeon's subjective assessment of surgical complexity

    Time frame: Right after the completion of the surgery

    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).

  8. Duration of surgical procedure (in minutes)

    Time frame: Right after the completion of the surgery

    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.

  9. Evolution of visual results (corrected and uncorrected)

    Time frame: 1 month after surgery

    Measurements with optotypes :

    Best monocular visual acuity (decimal scale converted to logMAR)

  10. Evolution of visual results (corrected and uncorrected)

    Time frame: 3 months after surgery

    Measurements with optotypes :

    Best monocular visual acuity (decimal scale converted to logMAR)

  11. Evolution of visual results (corrected and uncorrected)

    Time frame: 6 months after surgery

    Measurements with optotypes :

    Best monocular visual acuity (decimal scale converted to logMAR)

  12. Evolution of visual results (corrected and uncorrected)

    Time frame: 12 months after surgery

    Measurements with optotypes :

    Best monocular visual acuity (decimal scale converted to logMAR)

  13. Evolution of refractive results

    Time frame: 1 month after surgery

    Nidek® autorefractometer measurement :

    • Sphere (in dioptres)
    • Cylinder (in dioptres)
    • Spherical equivalent (in dioptres)
    • Cylinder axis (in degrees)

  14. Evolution of refractive results

    Time frame: 3 months after surgery

    Nidek® autorefractometer measurement :

    • Sphere (in dioptres)
    • Cylinder (in dioptres)
    • Spherical equivalent (in dioptres)
    • Cylinder axis (in degrees)

  15. Evolution of refractive results

    Time frame: 6 months after surgery

    Nidek® autorefractometer measurement :

    • Sphere (in dioptres)
    • Cylinder (in dioptres)
    • Spherical equivalent (in dioptres)
    • Cylinder axis (in degrees)

  16. Evolution of refractive results

    Time frame: 12 months after surgery

    Nidek® autorefractometer measurement :

    • Sphere (in dioptres)
    • Cylinder (in dioptres)
    • Spherical equivalent (in dioptres)
    • Cylinder axis (in degrees)

  17. Evolution of endothelial loss

    Time frame: 1 month after surgery

    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.

  18. Evolution of endothelial loss

    Time frame: 3 months after surgery

    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.

  19. Evolution of endothelial loss

    Time frame: 6 months after surgery

    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.

  20. Evolution of endothelial loss

    Time frame: 12 months after surgery

    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.

  21. Evolution of corneal thickness

    Time frame: 1 month after surgery

    Corneal thickness in μm measured by OCT - Avanti® type cornea.

  22. Evolution of corneal thickness

    Time frame: 3 months after surgery

    Corneal thickness in μm measured by OCT - Avanti® type cornea.

  23. Evolution of corneal thickness

    Time frame: 6 months after surgery

    Corneal thickness in μm measured by OCT - Avanti® type cornea.

  24. Evolution of corneal thickness

    Time frame: 12 months after surgery

    Corneal thickness in μm measured by OCT - Avanti® type cornea.

  25. Evolution of posterior keratometry

    Time frame: 1 month after surgery

    Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).

  26. Evolution of posterior keratometry

    Time frame: 3 months after surgery

    Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).

  27. Evolution of posterior keratometry

    Time frame: 6 months after surgery

    Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).

  28. Evolution of posterior keratometry

    Time frame: 12 months after surgery

    Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie YAVCHITZ

CONTACT

[email protected]

01.48.03.64.33 ext. +33

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: DMEK complexes

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 28, 2023
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.