SUCCESS Score Validation in Fuchs Dystrophy

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Conditions studied: Fuchs Endothelial Corneal Dystrophy

In brief

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.

Key facts

Study ID

NCT07265388

Run by

Instituto Ramón y Cajal de Investigación Sanitaria

People needed

250

Starts

2020-06-01

Expected to finish

2026-12-01

Last updated by the study team

2025-12-04

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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