High Myopia - Partial Reduction Orthokeratology Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Determine the change in cycloplegic axial length in the study and control groups
研究概览
简要总结
The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Determine the change in cycloplegic axial length in the study and control groups
时间窗: 2 years
次要结局
- Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups(2 years)
- Rate of regression during the daytime(2 years)
研究者
Pauline Cho
Professor
The Hong Kong Polytechnic University