ACTRN12611000582954已完成未知
Investigation of the efficacy of the third generation MC PAL lenses in the retardation of juvenile onset myopic progression in 7 to 12 year old children.
Carl Zeiss Vision0 个研究点目标入组 165 人开始时间: 2011年6月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 7 Years 至 12 Years（—）
- 性别
- All
入选标准
- •1) Spherical equivalent refractive error (SER) of –1.00 to -4.50 D
- •2) Astigmatism of not more than -1.50 D.
- •3) Anisometropia of not more than -1.50 D in spherical or cylindrical error.
- •4) Have best corrected visual acuity of at least 6/9 (20/30) in each eye.
- •5) Normal ocular health other than myopia.
- •6) No prior use of bifocal or progressive lenses in the last 12 months.
- •7) No RPG contact lens experience and must be willing not to wear contact lenses.
- •8) In satisfactory health.
- •9) Willing and able to tolerate cycloplegia (no previous adverse reaction to cycloplegics).
- •10) Informed parental consent.
排除标准
- •1) Any systemic condition which might affect refractive development or systemic diseases which may affect vision or refractive error.
- •2) Previous use of contact lens/PALs or other treatment for myopia within the last 12 months.
- •3) Defective binocular function.
- •4) Amblyopia and or manifested squint.
- •5) Vestibular disorders or motor imbalance.
- •6) Any other conditions precluding adherence to the Protocol.
- •7) Have best corrected visual acuity worse than 6/9 (20/30) in each eye.
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