Actively Recruiting

Age: 40Years +
All Genders
NCT07265388

SUCCESS Score Validation in Fuchs Dystrophy

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

250

Participants Needed

1

Research Sites

339 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

SUCCESS Score Validation in Fuchs Dystrophy

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 60 years.
  • Clinical diagnosis of Fuchs endothelial corneal dystrophy (FECD) grade 62 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.
Not Eligible

You will not qualify if you...

  • 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).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)

Madrid, Madrid, Spain, 28034

Actively Recruiting

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Research Team

F

Francisco Arnalich-Montiel, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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