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临床试验/NCT03857685
NCT03857685Unknown不适用

Bilateral and Age-dependent Differences in Posterior Capsule Opacification in Vivo Compared to an In-vitro Mode

Prim. Prof. Dr. Oliver Findl, MBA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Amount of proliferation of lens epithelial cells (LECs) in-vitro compared to in vivo in the same patient

研究概览

简要总结

Investigate the proliferative capacity of individual lens epithelium capsule specimens in vitro and correlate it to the risk of developing PCO

详细描述

Cataract, the clouding of the eye's lens, is still the leading cause of blindness worldwide. Until now surgery is the only therapy available for the disease. Cataract surgery is nowadays considered a safe and efficient therapy. However, one of the most frequent complications of cataract surgery is posterior capsule opacification (PCO), which results in diminished postoperative visual acuity. PCO occurs due to a robust wound-healing response, where remaining lens epithelial cells in the capsular bag start to migrate and proliferate.

The lens capsule is divided into an anterior, an equatorial, and a posterior region. The anterior and the equatorial region consist of a single layer of cuboidal epithelial cells, whilst the posterior region is formed of fibers. In the adult lens proliferation occurs almost exclusively in the equatorial region and although the central part of the lens epithelium exhibits very low mitotic activity, it was shown in experiments that cell in this area are also stem cells. There are three possible reasons for the generation of PCO: intraoperative factors (dependening on the amount of remaining cells in the capsular bag), intraocular lens factors, and interpersonal factor (patient-specific factors).

Aim of this study is the generation of an in-vitro model of posterior capsule opacification. Therefore, the investigators will analyse the proliferative capacity of lens epithelial cells on the lens capsule, which is removed during cataract surgery, in a cell culture model. The investigators then compare the proliferative capacity between young and old patients, between both eyes of the same patient, and in different forms of cataract.

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
21 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age-related cataract.
  • Patients in the age group of 21 years and older.
  • 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 with big differences in LOCS scale between the two eyes.
  • 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

Amount of proliferation of lens epithelial cells (LECs) in-vitro compared to in vivo in the same patient

时间窗: 24 months

Proliferation of LECs in-vitro will be measured as area/mm2 and correlated with ratings of posterior capsular opacification in vivo using a scale from 0 to 10

次要结局

  • Amount of proliferation of LECs in-vitro in young and older patients(24 months)
  • Amount of proliferation of LECs in-vitro between different forms of cataract(24 months)

研究者

发起方
Prim. Prof. Dr. Oliver Findl, MBA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (1)

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