Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (2) Discontinuation of Lens Wear in New Ortho-k Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change in Axial Elongation in the Two Study Phases
研究概览
简要总结
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.
详细描述
Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Younger myopic children (aged 6-10 years old) may have the faster increase in myopia than old myopic children (aged 11-15 years old), i.e. the rate of myopic progression may be different in different age groups and in children with different refractive status (Edwards 1999; Fan et al. 2004; Cheng et al. 2007). Although the refractive correction with ortho-k has been well documented, it is unknown whether the efficiency and reversibility of ortho-k for myopic reduction as well as myopic control are similar in children of different age and refractive groups.
In this 14-month study, the eyeball length in 45 younger (6-10 years old) and 45 older (11-15 years old) myopic children before and after ortho-k will be evaluated. Eyeball elongation will be determined for the first 7 months when single-vision glasses will be prescribed (Phase I) and the next 7 months when ortho-k will be prescribed (Phase I). Rate of myopic progression will be determined and compared between the two groups of children in the two phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
盲法说明
The outcome assessor was responsible for measuring the axial length and was unaware of the intervention (i.e. spectacles or orthokeratology) used by the subjects
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: between 6 to 15 years old
- •Myopia: between 1.50D and 4.50D in at least one eye
- •Spherical equivalent (SE): between -1.00D to -4.50D in both eyes
- •Astigmatism: ≤ 3.00D of axes 180 +/- 30 or ≤ 1.00D of other axes; and the amount is less than refractive sphere
- •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 to wear contact lenses or spectacles on a daily basis
- •Can obtain good ortho-k results with the study lenses
- •Availability for follow-up for at least 14 months
排除标准
- •Strabismus at distance or near
- •Contraindication for contact lens wear and ortho-k (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)
- •Prior experience with the use of rigid lenses (including ortho-k)
- •Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)
- •Non-compliance to the follow up schedule
- •Non-compliance to the use of the prescribed optical correction
- •Poor ocular response to ortho-k lens wear
- •Significant residual refractive error after ortho-k treatment resulting in poor unaided vision (worse than 0.18 in logMAR scale)
结局指标
主要结局
Change in Axial Elongation in the Two Study Phases
时间窗: 14 months
Axial elongation in children during the two study phases. Phase I: 7 months wearing single-vision spectacles. Phase II: 7 months wearing orthokeratology
次要结局
- Number of Participants With Serious Adverse Effects(14 months)
研究者
Pauline Cho
Professor
The Hong Kong Polytechnic University