Clinical trial NCT06013462: DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery
Official title: DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2023-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence rate of at least one serious DMEK post-op complication
timeFrame: 12 months
Secondary outcomes:
measure: Rebulling occurrence rate
timeFrame: 12 months
measure: Graft failure occurrence rate
timeFrame: 12 months
measure: Graft rejection occurrence rate
timeFrame: 12 months
measure: Macular cystoid edema occurrence rate
timeFrame: 12 months
measure: Intraocular hypertension occurrence rate
timeFrame: 12 months
measure: Graft detachment (with or without rebulling) occurrence rate
timeFrame: 12 months
measure: Surgeon's subjective assessment of surgical complexity
timeFrame: Right after the completion of the surgery
measure: Duration of surgical procedure (in minutes)
timeFrame: Right after the completion of the surgery
measure: Evolution of visual results (corrected and uncorrected)
timeFrame: 1 month after surgery
measure: Evolution of visual results (corrected and uncorrected)
timeFrame: 3 months after surgery
measure: Evolution of visual results (corrected and uncorrected)
timeFrame: 6 months after surgery
measure: Evolution of visual results (corrected and uncorrected)
timeFrame: 12 months after surgery
measure: Evolution of refractive results
timeFrame: 1 month after surgery
measure: Evolution of refractive results
timeFrame: 3 months after surgery
measure: Evolution of refractive results
timeFrame: 6 months after surgery
measure: Evolution of refractive results
timeFrame: 12 months after surgery
measure: Evolution of endothelial loss
timeFrame: 1 month after surgery
measure: Evolution of endothelial loss
timeFrame: 3 months after surgery
measure: Evolution of endothelial loss
timeFrame: 6 months after surgery
measure: Evolution of endothelial loss
timeFrame: 12 months after surgery
measure: Evolution of corneal thickness
timeFrame: 1 month after surgery
measure: Evolution of corneal thickness
timeFrame: 3 months after surgery
measure: Evolution of corneal thickness
timeFrame: 6 months after surgery
measure: Evolution of corneal thickness
timeFrame: 12 months after surgery
measure: Evolution of posterior keratometry
timeFrame: 1 month after surgery
measure: Evolution of posterior keratometry
timeFrame: 3 months after surgery
measure: Evolution of posterior keratometry
timeFrame: 6 months after surgery
measure: Evolution of posterior keratometry
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Alain SAAD
role: PRINCIPAL_INVESTIGATOR
References: