Validation and Extension of the SUCCESS Score for Fuchs Dystrophy After Cataract Surgery
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
RECRUITING
Madrid
Contact Information
Primary
Francisco Arnalich-Montiel, PhD
francisco.arnalich@salud.madrid.org
+34 913368853
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 250
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Instituto Ramón y Cajal de Investigación Sanitaria