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RECRUITINGOBSERVATIONAL

SUCCESS Score Validation in Fuchs Dystrophy

Validation and Extension of the SUCCESS Score for Fuchs Dystrophy After Cataract Surgery

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This prospective multicenter diagnostic study aims to externally validate and extend the SUCCESS Score for predicting the need for endothelial keratoplasty after cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). The model's performance and clinical utility are assessed using discrimination, calibration, and reclassification metrics.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults aged ≥40 years. - Clinical diagnosis of Fuchs endothelial corneal dystrophy (FECD) grade ≥2 on the modified Krachmer scale. - Presence of visually significant cataract requiring phacoemulsification surgery. - Ability to provide willing to sign a consent form and comply with study procedures. - Availability of preoperative Scheimpflug tomography and corneal densitometry measurements. Who Should NOT Join This Trial: - Epithelial or stromal edema precluding reliable corneal imaging. - Previous ocular surgery (including corneal or intraocular procedures). - Corneal trauma, infection, or inflammation affecting endothelial integrity. - Coexisting ocular pathologies that could confound postoperative assessment (e.g., advanced glaucoma, macular degeneration). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Adults aged ≥40 years. * Clinical diagnosis of Fuchs endothelial corneal dystrophy (FECD) grade ≥2 on the modified Krachmer scale. * Presence of visually significant cataract requiring phacoemulsification surgery. * Ability to provide informed consent and comply with study procedures. * Availability of preoperative Scheimpflug tomography and corneal densitometry measurements. Exclusion Criteria: * Epithelial or stromal edema precluding reliable corneal imaging. * Previous ocular surgery (including corneal or intraocular procedures). * Corneal trauma, infection, or inflammation affecting endothelial integrity. * Coexisting ocular pathologies that could confound postoperative assessment (e.g., advanced glaucoma, macular degeneration).

Treatments Being Tested

PROCEDURE

Phacoemulsification Cataract Surgery

Standard phacoemulsification cataract surgery performed in patients with Fuchs endothelial corneal dystrophy (FECD). All procedures are carried out according to institutional protocols at participating tertiary centers. Preoperative Scheimpflug tomography and corneal densitometry measurements are collected to calculate the SUCCESS Score and evaluate the risk of postoperative endothelial decompensation. Postoperative outcomes are monitored to determine whether endothelial keratoplasty (EK) is required during follow-up.

Locations (1)

Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
Madrid, Madrid, Spain