DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery
- Conditions
- Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery
- Registration Number
- NCT06013462
- Lead Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Rebulling occurrence rate 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.
Duration of surgical procedure (in minutes) 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.
Graft failure occurrence rate 12 months No improvement in pachymetry at three months post-op (Avanti OCT-cornea).
Graft rejection occurrence rate 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).
Macular cystoid edema occurrence rate 12 months Presence of intraretinal fluid in the macular area (macular OCT).
Surgeon's subjective assessment of surgical complexity 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).
Evolution of posterior keratometry 12 months after surgery Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
Graft detachment (with or without rebulling) occurrence rate 12 months Failure of the graft to press against the posterior host corneal stroma (Avanti OCT-cornea and slit-lamp biomicroscopic examination).
Evolution of refractive results 12 months after surgery Nidek® autorefractometer measurement :
1. Sphere (in dioptres)
2. Cylinder (in dioptres)
3. Spherical equivalent (in dioptres)
4. Cylinder axis (in degrees)Evolution of corneal thickness 12 months after surgery Corneal thickness in μm measured by OCT - Avanti® type cornea.
Evolution of visual results (corrected and uncorrected) 12 months after surgery Measurements with optotypes :
Best monocular visual acuity (decimal scale converted to logMAR)Evolution of endothelial loss 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.
Intraocular hypertension occurrence rate 12 months Intraocular pressure greater than 21mmHg measured by pneumotonometer or applanation tonometer.
Trial Locations
- Locations (1)
Fondation Ophtalmologique A de Rothschild
🇫🇷Paris, France