VALIDATING the SUCCESS Score to predict need for endothelial keratoplasty after cataract surgery in Fuchs dystrophy
Official title: Validation and Extension of the SUCCESS Score for Fuchs Dystrophy After Cataract Surgery
Run by Instituto Ramón y Cajal de Investigación Sanitaria · NCT07265388 · Data updated 2026-11-12
This study will test whether the SUCCESS Score, with corneal densitometry, can predict which people with Fuchs endothelial corneal dystrophy having cataract surgery will later need endothelial keratoplasty.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Instituto Ramón y Cajal de Investigación Sanitaria Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | June 1, 2020 |
| Main results expected | July 2026 |
| Study ends | December 2026 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07265388 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥40 years) with FECD grade ≥2 and a visually significant cataract scheduled for phacoemulsification who can complete preoperative Scheimpflug tomography and corneal densitometry.
✕Probably not a fit
Patients with preoperative epithelial or stromal edema, prior ocular surgery, active corneal infection or trauma, or other advanced ocular disease are unlikely to benefit from this prediction model.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, observational multicenter study enrolls adults with Fuchs endothelial corneal dystrophy (modified Krachmer grade ≥2) undergoing phacoemulsification across five tertiary centers in Spain. Preoperative Scheimpflug tomography and corneal densitometry are collected to calculate the SUCCESS Score and to explore extended prediction models. The primary outcome is requirement for endothelial keratoplasty after cataract surgery, and model performance will be measured using discrimination, calibration, and reclassification metrics. Patients with epithelial or stromal edema, prior ocular surgery, active corneal infection/trauma, or other confounding ocular pathology are excluded.
Why it matters
Potential benefit: If successful, the score could help surgeons and patients decide whether cataract surgery alone is likely to suffice or if earlier endothelial keratoplasty should be planned.
How similar studies have gone: The original SUCCESS Score showed promise in initial/single-center work, but external multicenter validation and the added value of corneal densitometry remain unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where it's running
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Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Francisco Arnalich-Montiel, PhD
- Email: francisco.arnalich@salud.madrid.org
- Phone: +34 913368853
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.