Myopic Control for High Myopes Using Orthokeratology (HM-PRO)
High Myopia - Partial Reduction Orthokeratology Study
研究概览
详细说明
Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment?
A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hong Kong SAR、中国
- School of Optometry, The Hong Kong Polytechnic University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Myopia (refractive sphere): > 5.75D
- Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
- Spherical equivalent (SE): > 5.75D
- Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
- Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
- Willingness for randomization
- Availability for follow-up for at least 2 years
Exclusion Criteria:
- Strabismus at distance or near
- Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
- Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
- Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Orthokeratology lenses
Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group
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Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years
其他名称：
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其他：Single-vision spectacle lenses
Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group
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Daily use of spectacles to correct the refractive error for a period of two years
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Determine the change in cycloplegic axial length in the study and control groups
大体时间：2 years
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2 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups
大体时间：2 years
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2 years
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Rate of regression during the daytime
大体时间：2 years
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2 years
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合作者和调查者
调查人员
- 首席研究员：Pauline Cho、The Hong Kong Polytechnic University
出版物和有用的链接
一般刊物
- Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res. 2005 Jan;30(1):71-80. doi: 10.1080/02713680590907256.
- Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J Ophthalmol. 2009 Sep;93(9):1181-5. doi: 10.1136/bjo.2008.151365. Epub 2009 May 4.
- Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.
- Charm J, Cho P. High myopia-partial reduction orthokeratology (HM-PRO): study design. Cont Lens Anterior Eye. 2013 Aug;36(4):164-70. doi: 10.1016/j.clae.2013.02.012. Epub 2013 Mar 18.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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