Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study
研究概览
简要总结
The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.
详细描述
Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).
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
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Myopia (refractive sphere): > 0.50D and ≤ 4.00D
- •Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
- •Spherical equivalent (SE): > 0.75D and ≤ 4.50D
- •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
- •Willingness to wear contact lenses or spectacles on a daily basis
- •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
- •Prior experience with the use of rigid lenses (including orthokeratology)
- •Prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles)
- •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
Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study
时间窗: 2 years
Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.
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)
- Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear(2 years)
研究者
Pauline Cho
Professor
The Hong Kong Polytechnic University