RecruitingNot Applicable

SUCCESS Score Validation in Fuchs Dystrophy

Spain250 participantsStarted 2020-06-01

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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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).

What they're measuring

Need for endothelial keratoplasty (EK) after cataract surgery in patients with Fuchs endothelial corneal dystrophy

Timeframe: Up to 36 months after cataract surgery

Trial details

NCT IDNCT07265388

SponsorInstituto Ramón y Cajal de Investigación Sanitaria

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07

Contact for this trial

Francisco Arnalich-Montiel, PhD

+34 913368853 francisco.arnalich@salud.madrid.org

View on ClinicalTrials.gov More Fuchs Endothelial Corneal Dystrophy trials