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临床试验/NCT05373693
NCT05373693Unknown不适用

Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
changes in cycloplegic objective spherical equivalent (SER)

研究概览

简要总结

The proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 D power and single vision lenses would be measured to assess the short term effect of PDL lens. Axial length and cycloplegic objective refractive error would be measured to assess the Myopia-control Efficacy.

详细描述

The proposed study below aims to assess the short-term and long-term effect of customized Bestivue PDL lenses on retinal image quality and myopia control. To these ends, two stages of testing are planned. First, objective testing will be utilized to assess the effect of Bestivue PDL lenses on visual acuity and image blur at various gaze directions and eccentricities on 4- to 13-year-old children fitted with +2 to 4 D power and single vision lenses.In the second stage, the same children participants will wear either single or Bestvue PDL lenses with one of the four plus power designs for 2 years. Their corrected visual acuity, objective refractive error with dilation and axial length will be assessed for each eye every six months for two years. Outcomes of these studies should inform whether Bestivue PDL lenses are effective in myopia control while affording adequate visual comfort and performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The subjects had spherical RE of -1.00 to -6.00 D
  • Astigmatism ≤ 4.00 D
  • Anisometropia ≤ 1.50 D\
  • Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.

排除标准

  • Strabismus
  • Ocular limitations
  • Systemic abnormalities affecting vision and ocular motility.

结局指标

主要结局

changes in cycloplegic objective spherical equivalent (SER)

时间窗: baseline, 24 months

changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.

次要结局

  • changes in ocular axial length(baseline, 24 months)
  • visual performance(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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