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临床试验/NCT04274634
NCT04274634Unknown不适用

The Oscillation of Crystalline and Intraocular Lenses: a Feasibility Study of the Lens' Movements in the Eye

Anglia Ruskin University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Assess the feasibility of implementing a larger study

研究概览

简要总结

The crystalline lens of the human eye helps to sharpen vision. There can be issues with the support/stability of the lens. This could be seen with the naked eye of an external observer or with the use of a slit lamp.

Certain eye conditions can predispose to issues with lens stability. If patients have stability issues with their natural lens- this would be termed as "phakodonesis". However, in patients who have had prior cataract surgery with implantation of an artificial lens (IOL)- this would be termed as "pseudophakodonesis". Eye conditions such as pseudoexfoliation or Marfan-syndrome can lead to unstable lens support- this can be detected if there are advanced stability issues.

However, small instability in the eye's would not be detected with present descriptive methods. The authors have designed a high-speed camera which is able to detect stability of the lens, especially during eye movements. The high-speed camera can detect variation in the change of light reflex from the lens and calculate the amount of lens instability/oscillation. The results (in normal eyes) of this high-speed camera has already been published in a peer-review journal. It is non-contact and measures lens movement. The test lasts less than 5 minutes.

Further research is required to assess the amount of lens oscillation (wobbling) in different eye populations - patients with previous cataract surgery (an artificial implant is used to replace the lens) or eye conditions (such as pseudoexfoliation, Marfan syndrome). The amount of lens stability has a role in the planning of further intraocular surgery - especially cataract extraction - however, at present, there is no approved quantitative measurement for this.

Participants will be recruited through Anglia Ruskin University (educational establishment), local community groups, and through Southend University Hospital eye clinics (NHS organisation). Participants' data will remain anonymous.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • >18 years old
  • Able to read and understand the English language

排除标准

  • Significant corneal scarring
  • Taking medications that cause miosis (pupil constriction)
  • Patients with no light perception
  • Patients unable to open their eyes e.g. due to significant ptosis

结局指标

主要结局

Assess the feasibility of implementing a larger study

时间窗: 1 year

Criteria: number of eligible participants.This can then inform the sample size calculation for the larger study.

次要结局

  • Assessing lens oscillation by damping ratio in different patient populations using a non-invasive, high-speed camera(1 year)
  • Assessing lens oscillation by the stationary time in different patient populations using a non-invasive, high-speed camera(1 year)
  • Assessing lens oscillation amplitude in different patient populations using a non-invasive, high-speed camera(1 year)
  • Assessing lens oscillation ("wobbliness") by oscillation frequency in different patient populations using a non-invasive, high-speed camera(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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