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临床试验/NCT03749798
NCT03749798Unknown不适用

To Collect and Compare Data With an Intraoperative Wavefront Device (HeLeNa) to a Standard Wavefront Device: an Explorative Pilot Study

Prim. Prof. Dr. Oliver Findl, MBA2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年9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
50
试验地点
2
主要终点
Wavefront aberration measurements

研究概览

简要总结

Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.

详细描述

Different technologies are in use for measuring wavefront aberrations, such as Hartmann-Shack wavefront aberrometry, Tscherning aberrometry, Laser Raytracing and automatic retinoscopy. While Hartmann-Shack wavefront aberrometry, the most widespread of these techniques, uses a lenslet array to record distortions of light bundles coming from a single source form the retina, Tscherning aberrometry uses a matrix of pinholes. Laser Ray Tracing in contrast measures the aberration of a laser beam at different locations. All three systems compare distorsions of the measured light beams with a perfect optical system to calculate the wavefront errors. Repeatability of wavefront devices was studied in young healthy subjects and different devices have been compared to each other. These results do not represent the typical cataract patient. Several factors, such as tear film instability and pupil size, have an influence on the measurements and these factors may change significantly with age.

Intraoperative measured data could help to get a better information about wavefront aberrations.

研究设计

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

入排标准

年龄范围
21 Years 至 105 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 21 and older
  • Able to understand the patient information
  • Willing to follow the instructions and attend all follow-up visits
  • Willing to sign informed consent prior to surgery

排除标准

  • Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
  • Previous ocular surgeries on the study eye
  • Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
  • Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)

结局指标

主要结局

Wavefront aberration measurements

时间窗: 12 months

Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative).

次要结局

未报告次要终点

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 (2)

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