跳至主要内容
临床试验/NCT01295164
NCT01295164终止不适用

Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
28
试验地点
2
主要终点
The primary outcome of the study is to evaluate the AOVIS-I and its wave-front sensor with high dynamic range for measuring high-order aberrations in patients with late stages (3 and 4) of keratoconus

研究概览

简要总结

The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. The optical condition of every eye is represented by its wave aberration. This characterization overcomes the current description based only in refractive errors. This provides an accurate description of the optics of the eye based on the assessment of the whole set of ocular aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as patients with keratoconus.

详细描述

The complete procedure in one patient takes less than 5 minutes and is completely non-invasive.

研究设计

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

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

  • to be able to understand an information and give a consent
  • patients over 18
  • patients with keratoconus
  • affiliated to medical insurance.

排除标准

  • non keratoconus patients
  • patients under 18
  • pregnant women or nursing mothers
  • ocular surgery 90 days before inclusion
  • ocular infection
  • keratitis
  • restless patients

结局指标

主要结局

The primary outcome of the study is to evaluate the AOVIS-I and its wave-front sensor with high dynamic range for measuring high-order aberrations in patients with late stages (3 and 4) of keratoconus

时间窗: at the 1st day

次要结局

  • To evaluate the reliability of the measures in early stages (1 and 2) of keratoconus as compared with a "classic aberrometer".(at the 1st day)
  • To describe the measures obtained in advanced stages (3 and 4) of keratoconus.(at the 1st day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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