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临床试验/JPRN-jRCTs032200060
JPRN-jRCTs032200060招募中4 期

Comparison of myopia control effects by combination therapy with multifocal SCL and atropine 0.01% ophthalmic solution, multifocal SCL monotherapy, combination therapy with sphere SCL and atropine 0.01% ophthalmic solution, versus sphere SCL monotherapy: a 1-year randomized four-armed clinical trial in myopic schoolchildren

Takahiro Hiraoka0 个研究点目标入组 240 人开始时间: 2020年6月30日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
240

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 6age old 至 <= 12age old(—)
性别
All

入选标准

  • 1) Male and female school children aged 6 to 12 at the time of obtaining consent (1st to 6th grade of elementary school)
  • 2) School children who have visual acuity loss in their visual acuity judgment during the past 1 year
  • 3) The results of the refractive test of both eyes under accommodative paralysis
  • -Both eyes have equivalent spherical power in the range of -1.00D to -6.00D
  • -The difference in equivalent spherical power between the left and right eyes is within 1.50D
  • -Astigmatic power is within plus/minus 1.00D
  • 4) School children who are able to perform accommodation paralysis
  • 5) School children who can receive medical examination according to this implementation plan
  • 6) Schoolchildren who obtained informed consent from the person concerned and parental authority for participation in this study

排除标准

  • 1) School children with abnormal binocular function (Titmas stress test less than 5/9)
  • 2) School children with amblyopia (corrected vision less than 1.0) or overt strabismus
  • 3) Corrected visual acuity measured with glasses is less than 1.0
  • 4) School children with abnormal intraocular pressure
  • 5) School children with a difference in equivalent spherical power under controlled paralysis and non-regulated paralysis of 1.50 D or more for both eyes
  • 6) School children with eye-related diseases other than myopia
  • 7) School children with eye-related or systemic disorders that may affect visual acuity or power.
  • 8) Multifocal contact lens, Bifocal glasses, progressive multifocal lens, orthokeratology lens, drug treatment, etc.
  • School children who have received myopia treatment
  • 9) In addition, school children judged by the research responsibility doctor to be inappropriate for this study

研究者

发起方
Takahiro Hiraoka

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