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Recruiting NCT07265388

SUCCESS Score Validation in Fuchs Dystrophy

Trial Parameters

Condition Fuchs Endothelial Corneal Dystrophy
Sponsor Instituto Ramón y Cajal de Investigación Sanitaria
Study Type OBSERVATIONAL
Phase N/A
Enrollment 250
Sex ALL
Min Age 40 Years
Max Age N/A
Start Date 2020-06-01
Completion 2026-07
Interventions
Phacoemulsification Cataract Surgery

Brief Summary

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.

Eligibility Criteria

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).

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