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RecruitingNCT07265388

SUCCESS Score Validation in Fuchs Dystrophy

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

Sponsor

Instituto Ramón y Cajal de Investigación Sanitaria

Enrollment

250 participants

Start Date

Jun 1, 2020

Study Type

OBSERVATIONAL

Conditions

Fuchs' Endothelial Corneal Dystrophy

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria5

  • Adults aged ≥40 years.
  • Clinical diagnosis of Fuchs endothelial corneal dystrophy (FECD) grade ≥2 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.

Exclusion Criteria4

  • 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).

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Interventions

PROCEDUREPhacoemulsification 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

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