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临床试验/NCT04597255
NCT04597255Unknown不适用

Reproducibility and Comparison of Digital Wavefront Sensing With Conventional Shack-Hartmann Wavefront Sensing: an Explorative Study

Medical University of Vienna0 个研究点目标入组 30 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
Qualitative description of lower order aberrations (LOA)

研究概览

简要总结

A holographic optical coherence tomography (H-OCT) setup is used to detect the wavefront by means of phase reconstruction.

详细描述

H-OCT will be tested in this study for its suitability for the qualitative investigation of aberrometry. We aim to achieve a digital equivalent for wavefront calculation of the widespread analog procedure commonly used with conventional wavefront-aberrometers. The results will be compared with those from a conventional analog wavefront calculation method.

In the course of this pilot study, 20 eyes of phakic and 10 eyes of pseudophakic subjects with suspected higher order aberrations will be examined using H-OCT.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Informed consent
  • •Men and women aged between 18 and 85 years
  • •Normal ophthalmic findings except refractive errors or suspected higher order aberrations
  • •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

排除标准

  • •Hyperopia > +6 Dpt. and Myopia < -6 Dpt.
  • •Known ophthalmic diseases such as age related macular degeneration, diabetic retinopathy, glaucoma, retinal detachment or previous ocular trauma and surgeries except cataract extraction
  • •Participation in a clinical trial in the previous 3 weeks
  • •Presence of any abnormalities preventing reliable measurements as judged by the investigator
  • •Pregnancy, planned pregnancy or lactating

研究组 & 干预措施

Holographic optical coherence tomography

Experimental

Healthy phakic participants

干预措施: Holographic optical coherence tomography (Device)

结局指标

主要结局

Qualitative description of lower order aberrations (LOA)

时间窗: 14 +/- 3 days

Zernike terms, RMS-error, Strehl ratio

Qualitative description of higher order aberrations (HOA)

时间窗: 14 +/- 3 days

Zernike terms, root mean square error , Strehl ratio

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doreen Schmidl

Doreen Schmidl [dschmidl]

Medical University of Vienna

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