Validation and Extension of the SUCCESS Score for Fuchs Dystrophy After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Need for endothelial keratoplasty (EK) after cataract surgery in patients with Fuchs endothelial corneal dystrophy
研究概览
简要总结
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.
详细描述
Fuchs endothelial corneal dystrophy (FECD) is a progressive corneal disorder characterized by endothelial cell loss, corneal edema, and visual impairment. In patients with FECD and cataract, an important clinical challenge is to predict whether cataract surgery alone will suffice or whether endothelial keratoplasty (EK) will be required postoperatively. Accurate preoperative risk stratification is essential for surgical planning and patient counseling.
The SUCCESS Score, derived from Scheimpflug tomography, was proposed as an objective index to estimate the risk of postoperative corneal decompensation in FECD. However, its external multicenter validation and the potential contribution of corneal densitometry have not yet been fully established.
This ongoing prospective, observational, multicenter study aims to externally validate and extend the SUCCESS Score for predicting the need for EK after cataract surgery in patients with FECD. The study is being conducted across five tertiary referral centers in Spain. Eligible participants are adults with FECD grade ≥2 on the modified Krachmer scale and a visually significant cataract requiring phacoemulsification. Patients with epithelial edema, prior ocular surgery, corneal infection, or trauma are excluded.
Preoperative evaluation includes Scheimpflug tomography and corneal densitometry analysis. The primary outcome is the requirement for endothelial keratoplasty after cataract surgery, determined by postoperative visual function and corneal evaluation. Model performance will be assessed through discrimination (Harrell's C statistic), calibration, reclassification (IDI, NRI), and decision curve analysis to estimate clinical utility.
The primary analysis is scheduled for completion in October 2024. Extended follow-up will continue until June 25, 2026, to assess long-term predictive performance and generalizability of the extended SUCCESS model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Need for endothelial keratoplasty (EK) after cataract surgery in patients with Fuchs endothelial corneal dystrophy
时间窗: Up to 36 months after cataract surgery
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.
次要结局
- 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))
研究者
Francisco Arnalich-Montiel
Lead investigator of the Ophtalmology department
Instituto Ramón y Cajal de Investigación Sanitaria