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临床试验/NCT04929119
NCT04929119Unknown不适用

The Effect of Wearing Orthokeratology on Objective Visual Quality

XiaoYong Liu1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
XiaoYong Liu
入组人数
30
试验地点
1
主要终点
Trefoil Aberrations in Microns

研究概览

简要总结

The visual quality indexes of these patients before and after Orthokeratology treatment were compared: 4 mm higher strehl ratio (SR) , 4 mm higher order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Comas, Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

详细描述

USING OPD-SCAN III instrument method: Drag The joystick to focus on the screen prompt, and the device automatically starts to measure the aberration when the yellow focus is shown; Simk will change from black to rose red when the aberration is measured to start measuring the corneal topography, prompting the patient to blink the tear film evenly and press the button on the joystick when the focus is completed.The following data were obtained and analyzed: 4 mm high order STREHL rate (SR) , 4 mm high order corneal aberration (Hoa ) , Spherical Aberration (SA) , Coma Aberration (Coma) , Trefoil Aberration (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
8 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The subject understands the purpose of this clinical trial and is willing, able and committed to return to the center for all clinical trial visits and to complete all research related procedures

排除标准

  • Associated with corneal abnormalities, such as active Keratitis (corneal infection) , corneal dystrophy, Keratoconus, corneal Leukoplakia, corneal hypoesthesia, or previous corneal surgery, or a history of corneal trauma;
  • 2, there are other eye diseases, such as Dacryocystitis, dry eye disease, conjunctivitis, blepharitis, Uveitis, and other inflammation, Glaucoma, cataracts, fundus disease, eye tumors, ocular trauma, squint patients;
  • A history of allergy to contact lens or contact Lens Solution.
  • Test results indicate that subjects with contraindications or unsuitable for wearing Orthokeratology.

结局指标

主要结局

Trefoil Aberrations in Microns

时间窗: 6 months

Objective visual quality 5

Coma Aberrations (COMA) in Microns

时间窗: 6 months

Objective visual quality 4

4 mm high-order strehl ratio

时间窗: 6 months

Objective visual quality 1

4 mm high-order corneal aberrations (Hoa) in Microns

时间窗: 6 months

Objective visual quality 2

Spherical Aberrations (SA) in Microns

时间窗: 6 months

Objective visual quality 3

corneal aspheric index(Q)

时间窗: 6 months

Objective visual quality 6

corneal aspheric index(e)

时间窗: 6 months

Objective visual quality 7

corneal surface regularity index (SRI)

时间窗: 6 months

Objective visual quality 8

corneal surface asymmetry index (Sai)

时间窗: 6 months

Objective visual quality 9

次要结局

未报告次要终点

研究者

发起方
XiaoYong Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

XiaoYong Liu

Deputy chief physician

First Affiliated Hospital of Jinan University

研究点 (1)

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