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

NCT04072029 | Completed

• 1 other identifier: 252/17
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Best spectacle corrected visual acuity

  2 months after cataract surgery

• Corneal tomography changes

  2 months after cataract surgery

• Postoperative refraction

  2 months after cataract surgery and after DMEK surgery

Study Arms (1)

Cataract - FECD

Eyes with FECD undergoing cataract surgery

Procedure: Phacoemulsification with intraocular lens implantation

Interventions

Phacoemulsification with intraocular lens implantation PROCEDURE

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

Cataract - FECD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for cataract surgery to the Cornea Department

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Interventions

Phacoemulsification; Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Francisco Arnalich Montiel, MD,PhD

  H.U. Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: August 28, 2019
• Study Start: July 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: February 7, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)