Risk Assessment for Progression to DMEK Following Cataract Surgery in Fuchs Endothelial Corneal Dystrophy
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|ClinicalTrials.gov Identifier: NCT04072029|
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : February 7, 2020
Justification. Fuchs' corneal endothelial dystrophy (FECD) is one of the main causes of corneal transplantation. In many cases, the corneal decompensation derived from this dystrophy is triggered as a consequence of cataract surgery, so the dilemma of facing isolated cataract surgery or combined with endothelial keratoplasty is often raised.
Objective. The present study aims to evaluate and select the most important predictive factors for corneal decompensation after cataract surgery in patients with FECD.
Method. Prospective observational study of the preoperative and intraoperative variables presumably associated with postoperative corneal edema requiring Descemet stripping endothelial keratoplasty (DMEK). Consecutive candidates for cataract surgery with FECD will be selected and anterior segment imaging will be performed, along with a complete ophthalmological examination. Clinical, pachymetric, tmographic, densitometric, specular microscopy, and intraoperative variables will be registered.
|Condition or disease||Intervention/treatment|
|Fuchs' Endothelial Dystrophy Cataract||Procedure: Phacoemulsification with intraocular lens implantation|
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|Official Title:||Escala de Riesgo de descompensación Corneal en cirugía de Catarata en Pacientes Con Distrofia Corneal de Fuchs|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||December 30, 2019|
|Actual Study Completion Date :||December 30, 2019|
Cataract - FECD
Eyes with FECD undergoing cataract surgery
Procedure: Phacoemulsification with intraocular lens implantation
Phacoemulsification (2.2mm coaxial, viscoelastic shield, experienced surgeon) with intraocular lens implantation (acrylic hidrophobic)
- Rate of progression to endothelial keratoplasty (DMEK) [ Time Frame: 2 months after cataract surgery ]Evaluation of baseline parameters that could predict the need for DMEK taking into account best espetacle corrected visual acuity and visual symptoms attributable to FECD and corneal edema (worse vision in the mornings, starburst or halos at night or subjective impairment of vision interfering with daily routine activities such as reading printed paper, looking at screens or driving)
- Best spectacle corrected visual acuity [ Time Frame: 2 months after cataract surgery ]Measured in logMAR scale
- Corneal tomography changes [ Time Frame: 2 months after cataract surgery ]Changes in pachymetric parameters (corneal thickness at the apex, center of the pupil, thinnest point and relative pachymetry) and densitometry (central corneal light backscatter) measured by Pentacam Scheimpflug tomograpy.
- Postoperative refraction [ Time Frame: 2 months after cataract surgery and after DMEK surgery ]Postoperative subjective refraction (sphere, cylinder, axis)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072029
|Hospital Universitario Ramón y Cajal|
|Madrid, Spain, 28034|
|Principal Investigator:||Francisco Arnalich Montiel, MD,PhD||H.U. Ramón y Cajal|