Evaluation of Intraoperative Capsular Polishing on Lens Epithelial Cells and the Development of Posterior Capsule Opacification
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison between eye with capsular polishing and eye without capsular polishing concerning generation of posterior capsule opacification (PCO) in the same patient
研究概览
简要总结
Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification
详细描述
Cataract, the clouding if the eye's lens, is the leading cause of blindness worldwide, with phacoemulsification and implantation of an intraocular lens being the only therapeutic option. Cataract surgery is nowadays considered a safe and efficient procedure. However, one of the most frequent complications after surgery is posterior capsule opacification (PCO), that results in diminished postoperative visual acuity. PCO occurs due to remaining lens epithelial cells in the capsular bag, that start to migrate and proliferate.
PCO can be easily treated by performing a neodymium-doped yttrium aluminium garnet (Nd-YAG) laser capsulotomy. However, even if laser capsulotomy is considered a simple procedure, possible complications are rise of intraocular pressure, inflammation, cystoid macular edema, or retinal detachment. Furthermore, several patients are no suitable candidates for laser capsulotomy, for example children and patients with high myopia.
Therefore, it would be necessery to identify different approaches to prevent generation of PCO. One approach could be "cleaning" of the lens epithelial cells in the capsular bag by polishing of the lens capsule during surgery. Hence, the aim of this study is to examine whether capsular polishing is beneficial to decrease the growth and proliferation of LECs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related cataract.
- •Patients in the age group of 21 years and above.
- •Patients with uncomplicated cataract.
- •Patients without any relevant systemic or ocular morbidity.
- •Patients with well dilating pupils.
- •Written informed consent prior to any study specific action.
排除标准
- •Patients with complicated cataract.
- •Patients having corneal pathology.
- •Patients with any form of ocular inflammation.
- •Patients with glaucoma, retinal pathologies.
- •Patients with traumatic cataracts, subluxated and dislocated lens, prior h/o ocular surgery, pseudoexfoliation.
- •Any intraoperative complications like posterior capsule rupture.
- •In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
结局指标
主要结局
Comparison between eye with capsular polishing and eye without capsular polishing concerning generation of posterior capsule opacification (PCO) in the same patient
时间窗: 6 months
Posterior capsule opacification will be graded using a score from 0 (clear capsule) to 10 (very severe PCO)
次要结局
- Difference in the number of cells in the anterior chamber between the eye with capsular polishing and the eye without capsular polishing in the same patient(6 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principle Investigator
Vienna Institute for Research in Ocular Surgery