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

Completed

• Conditions: Cataract; Fuchs' Endothelial Dystrophy
• Interventions: Procedure: Phacoemulsification with intraocular lens implantation

• Registration Number: NCT04072029
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cataract - FECD	Phacoemulsification with intraocular lens implantation	Eyes with FECD undergoing cataract surgery

Primary Outcome Measures

Name	Time	Method
Rate of progression to endothelial keratoplasty (DMEK)	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain