跳至主要内容
临床试验/NCT06726499
NCT06726499已完成不适用

Orthokeratology Lens Decentration with Two Designs of Corneal Refractive Therapy™ Lenses: a One-year Prospective Study

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年6月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
contact lens centration

研究概览

简要总结

Background/Objectives: To examine the trend of treatment zone (TZ) decentration over 12 months of Orthokeratology (OK) wear using two corneal refractive therapy (CRT) lens designs: standard (STD) and dual axis (DA). Methods: A prospective, randomized, longitudinal study was conducted at the Optometry Clinic of the Complutense University of Madrid. Subjects were fitted with STD or DA designs in one of the eyes, randomly. Refraction, uncorrected visual acuity (VA) and corneal topography were performed at baseline, 1-night, 1-week, 1-, 3-, 6- and 12-month of lens wear. Subjects requiring lens parameter adjustments or replacements after 3 months were excluded. Decentration was measured by subtracting pre-OK from post-OK tangential curvature maps at each visit, with decentration distance and corneal optical TZ measured using MATLAB. Correlations between decentration and visual acuity (VA) were also analyzed.

研究设计

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

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 8 to 17 years old
  • •Myopia up -6.00 D

排除标准

  • •Ocular diseases

研究组 & 干预措施

spherical design

Experimental

干预措施: Spherical CRT (Device)

Toric Design

Experimental

干预措施: Toric CRT (Device)

结局指标

主要结局

contact lens centration

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gonzalo Carracedo

Principal Investigator

Universidad Complutense de Madrid

研究点 (1)

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