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临床试验/NCT06345846
NCT06345846Unknown不适用

Tilt, Centration and Stability of Secondary Intraocular Lenses With no Capsular Support

Vienna Institute for Research in Ocular Surgery2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年12月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
82
试验地点
2
主要终点
Centration of the IOL

研究概览

简要总结

Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support.

详细描述

Acquired or congenital weakness of the zonules, either as part of a pseudoexfoliation syndrome (PEX), high myopia, past ocular trauma, post vitreoretinal surgery, and recurrent uveitis are the most common reasons for implantation of a secondary intraocular lenses (IOL) after cataract surgery. There are several techniques available to implant a secondary IOL in eyes with inadequate capsular support. Some of the most common techniques are the placement of a chamber angle-supported anterior chamber IOL (ACIOL), an iris-fixated IOL (IFIOL) and several different possibilities of scleral fixation of the IOL (SFIOL).

While those methods have all been found to show high safety and efficiency, there are certain procedure-specific limitations. One approach to sutureless implantation of a SFIOL is the "double needle flanged technique" described by Yamane et al. When using this technique, there is no need for extensive scleral incisions or distinct scleral manipulation, however, it may be challenging for the surgeon and may lead to complications such as "iris-optic-capture".

Past studies found no significant difference of postoperative best corrected visual acuity or rate of complications when comparing the three mentioned techniques, therefore, up to now choice of implantation and fixation technique lies with the surgeon's preferences and abilities. However, all three techniques have their drawbacks.

Hence, the aim of this study is to assess the centration, tilt, and wobble of secondary IOLs (comparing an IFIOL and a SFIOL) without capsular support.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Secondary IOL implantation performed at the Hanusch Hospital
  • IFIOL or SFIOL implanted
  • Older than 21 years
  • Written informed consent prior to recruitment

排除标准

  • Concurrent participation in another drug or device clinical investigation
  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)

结局指标

主要结局

Centration of the IOL

时间窗: 24 months

Centration of the IOL will be measured in mm using a Purkinjemeter

次要结局

  • Tilt of the IOL(24 months)

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (2)

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