+1 877 705 1914• 24 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Age: 40Years +
All Genders
ID07265388

Validating and Improving the SUCCESS Score to Predict Need for Endothelial Keratoplasty in Adults with Fuchs Endothelial Corneal Dystrophy Undergoing Cataract Surgery

Led by Instituto Ramón y Cajal de Investigación Sanitaria · Updated on 2025-12-04

250

Participants Needed

1

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Fuchs endothelial corneal dystrophy FECD is a progressive eye condition causing loss of endothelial cells, corneal swelling, and vision problems. This study aims to validate and extend the SUCCESS Score, a tool designed to predict whether patients with FECD who have cataracts will need additional corneal transplant surgery called endothelial keratoplasty EK after cataract surgery. The research evaluates the models accuracy and usefulness across multiple centers. Participants undergo standard phacoemulsification cataract surgery, with preoperative assessments including Scheimpflug tomography and corneal densitometry to calculate the SUCCESS Score. The study collects data on postoperative outcomes to determine if EK is needed. This observational study is conducted across five tertiary centers in Spain and includes follow-up for up to 36 months after surgery. The study also plans to provide an online calculator to assist in clinical decisions. During the study, researchers monitor participants visual function and corneal health after cataract surgery to assess the need for EK. They analyze the SUCCESS Scores performance using statistical methods for discrimination, calibration, and reclassification. The primary analysis occurs in October 2024, with extended follow-up until June 2026 to evaluate long-term predictive accuracy. Participants are involved through routine clinical assessments and imaging before and after surgery.

CONDITIONS

Brief Title

SUCCESS Score Validation in Fuchs Dystrophy

Research Team

F

Francisco Arnalich-Montiel, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here