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临床试验/NCT04452448
NCT04452448已完成2 期

Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles

Alexandria University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年1月10日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Visual acuity

研究概览

简要总结

This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

详细描述

The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Myopia up to -8.0 D and astigmatism up to -2.0D.
  • •Cases above 18 years of age with a stable refraction for at least one year.

排除标准

  • •Keratoconus.
  • •Patients with collagen diseases.
  • •Previous LASIK or any other refractive surgery.
  • •Severe dry eye syndrome.

研究组 & 干预措施

Laser in situ keratomileusis

Experimental

A prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK)

干预措施: LASIK (Device)

结局指标

主要结局

Visual acuity

时间窗: 3 months

Unaided as well as best corrected visual acuity

Manifest refraction

时间窗: 3 months

Manifest refraction

Evaluation of ocular aberrations

时间窗: 3 months

3. Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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