NCT07265388

SUCCESS Score Validation in Fuchs Dystrophy

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Instituto Ramón y Cajal de Investigación Sanitaria · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fuchs endothelial corneal dystrophy (FECD) is a progressive corneal disorder characterized by endothelial cell loss, corneal edema, and visual impairment. In patients with FECD and cataract, an important clinical challenge is to predict whether cataract surgery alone will suffice or whether endothelial keratoplasty (EK) will be required postoperatively. Accurate preoperative risk stratification is essential for surgical planning and patient counseling. The SUCCESS Score, derived from Scheimpflug tomography, was proposed as an objective index to estimate the risk of postoperative corneal decompensation in FECD. However, its external multicenter validation and the potential contribution of corneal densitometry have not yet been fully established. This ongoing prospective, observational, multicenter study aims to externally validate and extend the SUCCESS Score for predicting the need for EK after cataract surgery in patients with FECD. The study is being conducted across five tertiary referral centers in Spain. Eligible participants are adults with FECD grade ≥2 on the modified Krachmer scale and a visually significant cataract requiring phacoemulsification. Patients with epithelial edema, prior ocular surgery, corneal infection, or trauma are excluded. Preoperative evaluation includes Scheimpflug tomography and corneal densitometry analysis. The primary outcome is the requirement for endothelial keratoplasty after cataract surgery, determined by postoperative visual function and corneal evaluation. Model performance will be assessed through discrimination (Harrell's C statistic), calibration, reclassification (IDI, NRI), and decision curve analysis to estimate clinical utility. The primary analysis is scheduled for completion in October 2024. Extended follow-up will continue until June 25, 2026, to assess long-term predictive performance and generalizability of the extended SUCCESS model. An interactive web-based calculator implementing both the original and extended SUCCESS models will be provided as a supplementary tool to facilitate clinical use and standardized patient counseling across participating centers.

Conditions

• Fuchs Endothelial Corneal Dystrophy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: Spain