跳至主要内容
临床试验/NCT03893838
NCT03893838Unknown不适用

Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery - Preliminary Study Assessing Their Prevalence, Methods of Reductions of Symptoms and Time-dependent Changes in Patients Symptoms

Wrocław University of Science and Technology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2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
100
试验地点
1
主要终点
Chromoretinoscopy for near (MEM) and distance

研究概览

简要总结

Refractive surgeries can be divided into two distinct categories: 1) corneal surgeries (superficial and deep procedures) carried on the surface of the eye and 2) lens surgeries (phakic IOL, refractive lens exchange) - an intraocular intervention, performed in the anterior or posterior chamber or on the lens. In the proposed protocol focus is on the corneal refractive surgeries impact on monochromatic higher-order aberrations on the one hand and chromatic aberrations on the other. During the surgery in order to get the patient emmetropic, refractive surgery corrects optical defects by decreasing aberrations of lower orders ) simultaneously increases high-order aberrations (that is perceived by the patient as halo, glare or starburst). Informations about prevalence and causes of higher order aberrations after refractive surgery are numerous but there is no information about chromatic aberrations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • patient after corneal refractive surgery at least for 4 months
  • post surgical refraction within +/- 0.75 diopter of spherical and +/- 1.0 diopter of cylindrical error
  • willing and able to understand and sign an informed consent form.

排除标准

  • patient unable to participate in the study
  • any corneal diseases, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
  • corneal macula and obvious pannus; current enrolment in another clinical trial/research project

结局指标

主要结局

Chromoretinoscopy for near (MEM) and distance

时间窗: 6 months

Conducted with a modified by researchers retinoscopy with distinct filters

Transverse chromatic aberration

时间窗: 6 months

Conducted with a modified by researchers aniseikonia test (with red and green lenses)

number of high order and chromatic aberrations after refractive surgery

时间窗: 6 months

number of high order and chromatic aberrations after refractive surgery

Aberrometry reading for corneal HOA

时间窗: 6 months

Conducted with aberrometer and corneal tomography

次要结局

  • Change in Hue 100 test(6 months)
  • Change of contrast sensitivity for near vision(6 months)
  • Visual Function Questionaire 25(6 months)

研究者

发起方
Wrocław University of Science and Technology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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