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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Occurrence rate of at least one serious DMEK post-op complication [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Rebulling occurrence rate [Срок оценки: 12 months]
• Graft failure occurrence rate [Срок оценки: 12 months]
• Graft rejection occurrence rate [Срок оценки: 12 months]
• Macular cystoid edema occurrence rate [Срок оценки: 12 months]
• Intraocular hypertension occurrence rate [Срок оценки: 12 months]
• Graft detachment (with or without rebulling) occurrence rate [Срок оценки: 12 months]
• Surgeon's subjective assessment of surgical complexity [Срок оценки: Right after the completion of the surgery]
• Duration of surgical procedure (in minutes) [Срок оценки: Right after the completion of the surgery]
• Evolution of visual results (corrected and uncorrected) [Срок оценки: 1 month after surgery]
• Evolution of visual results (corrected and uncorrected) [Срок оценки: 3 months after surgery]
• Evolution of visual results (corrected and uncorrected) [Срок оценки: 6 months after surgery]
• Evolution of visual results (corrected and uncorrected) [Срок оценки: 12 months after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Fondation Ophtalmologique A de Rothschild — Paris

Идентификаторы

NCT: NCT06013462 · ASD_2023_6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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