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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Fuchs' Endothelial Dystrophy
• Intervention / Treatment: Procedure: Phacoemulsification with intraocular lens implantation

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients referred for cataract surgery to the Cornea Department

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of progression to endothelial keratoplasty (DMEK)	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)	2 months after cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best spectacle corrected visual acuity	Measured in logMAR scale	2 months after cataract surgery
Corneal tomography changes	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.	2 months after cataract surgery
Postoperative refraction	Postoperative subjective refraction (sphere, cylinder, axis)	2 months after cataract surgery and after DMEK surgery

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Investigators: Principal Investigator: Francisco Arnalich Montiel, MD,PhD, H.U. Ramón y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Lens Diseases; Corneal Diseases; Corneal Dystrophies, Hereditary; Cataract; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 252/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No