A Risk Prediction Model for Endothelial Keratoplasty After Uncomplicated Cataract Surgery in Fuchs Endothelial Corneal Dystrophy.
Francisco Arnalich-Montiel, Pablo de-Arriba-Palomero, Alfonso Muriel...
https://pubmed.ncbi.nlm.nih.gov/33951443Actively Recruiting
Age: 40Years +
All Genders
ID07265388
Validation and Extension of the SUCCESS Score for Fuchs Dystrophy After Cataract Surgery
Led by Instituto Ramón y Cajal de Investigación Sanitaria · Updated on 2025-12-04
250
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fuchs endothelial corneal dystrophy (FECD) is a progressive eye condition causing loss of endothelial cells, corneal swelling, and vision problems. This study aims to validate and extend the SUCCESS Score, a tool designed to predict whether patients with FECD who have cataracts will need additional corneal transplant surgery called endothelial keratoplasty (EK) after cataract surgery. The research evaluates the model's accuracy and usefulness across multiple centers. Participants undergo standard phacoemulsification cataract surgery, with preoperative assessments including Scheimpflug tomography and corneal densitometry to calculate the SUCCESS Score. The study collects data on postoperative outcomes to determine if EK is needed. This observational study is conducted across five tertiary centers in Spain and includes follow-up for up to 36 months after surgery. The study also plans to provide an online calculator to assist in clinical decisions. During the study, researchers monitor participants' visual function and corneal health after cataract surgery to assess the need for EK. They analyze the SUCCESS Score's performance using statistical methods for discrimination, calibration, and reclassification. The primary analysis occurs in October 2024, with extended follow-up until June 2026 to evaluate long-term predictive accuracy. Participants are involved through routine clinical assessments and imaging before and after surgery.
CONDITIONS
Brief Title
SUCCESS Score Validation in Fuchs Dystrophy
Who Can Participate
Age: 40Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 40 years or older
- Clinical diagnosis of Fuchs endothelial corneal dystrophy (FECD) grade 2 or higher 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 will not qualify if you...
- Presence of epithelial or stromal edema preventing reliable corneal imaging
- Previous ocular surgery including corneal or intraocular procedures
- Corneal trauma, infection, or inflammation affecting endothelial integrity
- Coexisting eye conditions that may interfere with postoperative assessment such as advanced glaucoma or macular degeneration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 week
Preoperative evaluation including Scheimpflug tomography and corneal densitometry measurements to calculate the SUCCESS Score and assess risk for postoperative complications.
1 visit (in-person)
Surgery
Duration - 1 day
Participants undergo standard phacoemulsification cataract surgery according to institutional protocols.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 36 months
Participants are monitored postoperatively for up to 36 months to assess the need for endothelial keratoplasty and evaluate visual function and corneal health.
Regular follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
Madrid, Madrid, Spain, 28034
Actively Recruiting
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Research Team
F
Francisco Arnalich-Montiel, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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