Skip to main content
OpenTrials
Completed

NCT Number: NCT04072029

Risk Assessment for Progression to DMEK Following Cataract Surgery in Fuchs Endothelial Corneal Dystrophy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fuchs' Endothelial Dystrophy Cataract Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Lens Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • FECD grade 2 or worse (modified Krachmer scale)
  • Cataract requiring surgery
  • Epithelial corneal edema evident in slit lamp examination

Exclusion criteria

  • Concurrent anterior corneal dystrophy
  • History of ocular trauma, ocular surgery, previous ocular inflammation or infection,uncotroled glaucoma, amblyopia, neovascular age-related macular degeneration, or active vacular retinal disease.
  • Non-collaborative or unable to receive postoperative care at our institution.

Treatment and study plan

Phacoemulsification With Intraocular Lens Implantation

Procedure

Phacoemulsification (2.2mm coaxial, viscoelastic shield, experienced surgeon) with intraocular lens implantation (acrylic hidrophobic)

Primary outcomes

  1. 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)

Secondary outcomes

  1. Best spectacle corrected visual acuity

    Time frame: 2 months after cataract surgery

    Measured in logMAR scale

  2. 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.

  3. Postoperative refraction

    Time frame: 2 months after cataract surgery and after DMEK surgery

    Postoperative subjective refraction (sphere, cylinder, axis)

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

Escala de Riesgo de descompensación Corneal en cirugía de Catarata en Pacientes Con Distrofia Corneal de Fuchs

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Feb 7, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.