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SUCCESS Score Validation in Fuchs Dystrophy

NCT07265388 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

  • Fuchs Endothelial Corneal Dystrophy

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.

Sponsors & Collaborators

  • Instituto Ramón y Cajal de Investigación Sanitaria

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07265388 on ClinicalTrials.gov