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RECRUITING
NCT07265388

SUCCESS Score Validation in Fuchs Dystrophy

Sponsor: Instituto Ramón y Cajal de Investigación Sanitaria

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2020-06-01

Completion Date

2026-12

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

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