SUCCESS Score Validation in Fuchs Dystrophy

NCT07265388 | Recruiting

• 2 other identifiers: SUCCESS-FUCHSPI22/01252
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fuchs Endothelial Corneal Dystrophy; Cataract Surgery; endothelial keratoplasty; Diagnostic Accuracy; Prognostic Validation; Predictive Modeling

Outcome Measures

Primary Outcomes (1)

• Need for endothelial keratoplasty (EK) after cataract surgery in patients with Fuchs endothelial corneal dystrophy

  The primary outcome is the need for endothelial keratoplasty (EK) following phacoemulsification cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). The endpoint is determined based on postoperative best-corrected visual acuity, corneal clarity, and presence of clinical signs of corneal decompensation. Each eye is evaluated using standardized follow-up visits and imaging criteria across participating centers. The decision to perform EK is made according to established clinical indications by the attending ophthalmologist, ensuring consistency across study sites.

  Up to 36 months after cataract surgery

Secondary Outcomes (3)

• Model discrimination (Harrell's C statistic) of the SUCCESS Score

  At primary analysis (October 2024)

• Calibration and predictive accuracy of the SUCCESS Score

  At primary analysis (June 2026)

• Reclassification and clinical utility of the extended SUCCESS model

  At primary analysis (June 2026)

Study Arms (1)

FECD Cohort

Patients with clinically diagnosed Fuchs endothelial corneal dystrophy (FECD) undergoing phacoemulsification cataract surgery at participating tertiary centers. All participants receive standard cataract surgery, and their preoperative data are used to calculate the SUCCESS Score with and without corneal densitometry parameters. Postoperative outcomes are monitored to determine the need for endothelial keratoplasty (EK).

Procedure: Phacoemulsification Cataract Surgery

Interventions

Phacoemulsification Cataract Surgery PROCEDURE

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.

FECD Cohort

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

dults with clinically diagnosed Fuchs endothelial corneal dystrophy (FECD) and visually significant cataract who are scheduled to undergo phacoemulsification surgery at participating tertiary referral centers in Spain. Eligible participants present FECD grade ≥2 on the modified Krachmer scale and have available preoperative Scheimpflug tomography and corneal densitometry measurements. The study population represents a real-world clinical cohort of patients routinely evaluated in corneal and cataract units, allowing assessment of the predictive performance and clinical utility of the SUCCESS Score under standard care conditions.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Ramón y Cajal de Investigación Sanitaria: lead

Study Sites (1)

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

Madrid, Madrid, 28034, Spain

RECRUITING

Related Publications (1)

• Arnalich-Montiel F, de-Arriba-Palomero P, Muriel A, Mingo-Botin D. A Risk Prediction Model for Endothelial Keratoplasty After Uncomplicated Cataract Surgery in Fuchs Endothelial Corneal Dystrophy. Am J Ophthalmol. 2021 Nov;231:70-78. doi: 10.1016/j.ajo.2021.04.016. Epub 2021 May 2.

  PMID: 33951443 RESULT

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Francisco Arnalich-Montiel, PhD

CONTACT

+34 913368853; francisco.arnalich@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead investigator of the Ophtalmology department

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: June 1, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication and ending 36 months after publication.
• Access Criteria: Qualified researchers affiliated with academic or non-profit institutions may request access to the deidentified individual participant data (IPD), study protocol, statistical analysis plan, and analytic code. Requests must include a methodologically sound proposal describing the intended analyses and objectives. Data and supporting materials will be shared through a secure institutional data repository managed by the Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Access will be granted upon approval by the study's data governance committee and completion of a data use agreement ensuring appropriate data handling and confidentiality.

Locations

ES (1)