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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fuchs' Endothelial Dystrophy, Cataract

Intervention / Treatment
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* Procedure: Phacoemulsification with intraocular lens implantation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cataract - FECD<br>Eyes with FECD undergoing cataract surgery | Procedure: Phacoemulsification with intraocular lens implantation<br>* Phacoemulsification (2.2mm coaxial, viscoelastic shield, experienced surgeon) with intraocular lens implantation (acrylic hidrophobic)<br>|

What is the study measuring?
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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 |