Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.
研究概览
简要总结
The aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery.
Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. One hundred and seventy-five eyes of hundred and four patients who have appointment for cataract surgical indication were included. The percentage of corneal endothelial cell loss was quantified using specular microscopy before and 3 months after the surgery.
14 variables (pre-operative and intra-operative) that could be associated to endothelial cell injury were selected.
A bivariate analysis of relationship between these factors and endothelial cell loss at 3 months was performed by simple linear regression (Wilcoxon and Fischer tests). Multivariate analysis was performed by multiple linear regression in order to identify the factors independently related to endothelial cell loss.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cataract surgery
- •Visual acuity monoyer scale <8/10e (> +0.2 logMar)
- •Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
- •Covered by the social security scheme
- •Have given their oral agreement
排除标准
- •Corneal disease: keratitis, dystrophy or corneal degeneration
- •Any disease of the anterior segment
- •Low preoperative endothelial cell density <1000 c/mm²
- •Pregnancy, lactation
- •Risk factors for surgical per-operative complication
- •Uncontrolled ocular pressure
- •Combined surgery (cataract with corneal graft, cataract with glaucoma surgery, cataract with vitrectomy, ....)
- •Under legal protection
结局指标
主要结局
The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.
时间窗: 3 months after cataract surgery
Specular counts were performed by the orthoptists, residents or physicians of the department using a Nidek CEM-530 specular microscope with automated central cell counting without corneal contact. Three measurements were performed at each consultation and the average of these three measurements was reported.
次要结局
- Postoperative corneal edema(3 months after cataract surgery)
- Postoperative visual acuity(3 months after cataract surgery)