SUCCESS Score Validation in Fuchs Dystrophy
ConditionFuchs Endothelial Corneal Dystrophy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorInstituto Ramón y Cajal de Investigación Sanitaria
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Phacoemulsification Cataract Surgery
Procedure/SurgeryStandard 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: FECD Cohort1 intervention
Trial outcomes
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.
Time frame
Up to 36 months after cataract surgerySecondary outcomes
1
Model discrimination (Harrell's C statistic) of the SUCCESS Score
Model discrimination will be assessed using Harrell's C statistic (concordance index) to quantify how accurately the SUCCESS Score predicts the need for endothelial keratoplasty after cataract surgery in patients with FECD.
Time frame
At primary analysis (October 2024)2
Calibration and predictive accuracy of the SUCCESS Score
Calibration plots and Brier score will be used to evaluate the agreement between predicted and observed probabilities of endothelial keratoplasty. Goodness-of-fit will be assessed across deciles of predicted risk.
Time frame
At primary analysis (June 2026)3
Reclassification and clinical utility of the extended SUCCESS model
The incremental value of adding corneal densitometry to the SUCCESS Score will be assessed using Integrated Discrimination Improvement (IDI), Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA) to determine potential clinical benefit.
Time frame
At primary analysis (June 2026)Sponsors and contacts
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Source ClinicalTrials.gov