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临床试验/NCT05265832
NCT05265832已完成不适用

Identification of Factors That Influence the Corneal Endothelial Cell Loss During Phacoemulsification

Centre Hospitalier Régional Metz-Thionville3 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2022年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
154
试验地点
3
主要终点
Postoperative endothelial cell loss

研究概览

简要总结

This is a multi-center cohort study with prognostic aims to identify factors associated with endothelial cell loss during cataract surgery.

Patients will have their endothelial density measured by specular microscopy preoperatively, at 1 month and at 3 months after surgery. The rest of their management will be in line with standard practice.

详细描述

Cataract surgery is the most commonly performed surgical procedure worldwide. Postoperative visual function depends on implant into the crystalline lens, retinal lesion, corneal damage or glaucomatous damage. Moreover, preoperative corneal endothelial damage should be as low as possible to provide corneal transparency. Indeed, the endothelium plays important role in maintaining corneal transparency.

The loss rate of endothelial cell after cataract surgery ranges in the scientific literature from 8 to 15 %. Severe endothelial cell loss contributes to corneal edema. This edema resulting in a loss of visual acuity and may require corneal transplantation as a last resort.

Various studies describe some factors that affecting endothelial cell loss such as the cataract density, pupil abnormalities (small diameter), Advanced age or short axial length.

However, few studies have been demonstrated the link between endothelial cell loss and the volume of fluid used during the intervention or the use of intracamerular substances. This study wants to establish a correlation between endothelial cell loss and predictive factors. Thus, knowledge of these factors would have ensured a better control of endothelial dysfunction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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

Postoperative endothelial cell loss

时间窗: Month 3

Difference in endothelial cell density between preoperative measurements and 3 months after surgery

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Régional Metz-Thionville
申办方类型
Other
责任方
Sponsor

研究点 (3)

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