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临床试验/NCT06583954
NCT06583954已完成不适用

PROOF OF CONCEPT OF A NEW DEVICE FOR SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY

Daniela Nosch2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
precision of determination of refractive error

研究概览

简要总结

The aim of this study is to test whether it is possible in principle to determine defective vision using light field technology. The measurements with this first prototype will be compared with the results of the conventional method for subjective refraction determination and those using a phoropter (Vision R-800 phoropter).

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Minimum age of 18 years
  • Best corrected visual acuity ≥ 0.8 (logMAR ≤ 0.1).
  • Dioptric range for hypermetropia: ≤ +4.50 D.
  • Dioptric range for myopia: ≥ -6.50 D.
  • Dioptric range for cylinder: ≤ -2.00 D.
  • Good general health, i.e.no systemic disease such as diabetes or rheumatism which could influence ocular health
  • No ocular pathology or history of (intra)ocular surgery except for cataract surgery

排除标准

  • • Contact lens wear during the days of visit
  • Binocular vision problems (e.g. amblyopia, strabismus).
  • Inability to follow the procedures of the investigation, such as language problems, psychological disorders and dementia

结局指标

主要结局

precision of determination of refractive error

时间窗: within one week

To explore if this prototype CREAL device based on LightField Technology can determine the refractive error reliably, in comparison to well-established methods such as subjective refraction with a trial frame and with the phoropter Vision-R 800 (Essilor SA).

次要结局

  • repeatability of all three methods for subjective refraction(within one week)

研究者

发起方
Daniela Nosch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniela Nosch

Lecturer

University of Applied Sciences and Arts Northwestern Switzerland

研究点 (2)

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