NCT02643342已完成不适用
A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Axial length
研究概览
简要总结
This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.
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 (Outcomes Assessor)
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
- •6 to 10 years old
- •Myopia: between 0.50 D and 4.00 D in both eyes
- •Astigmatism: <1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
- •Anisometropia: ≤ 1.50 D
- •Symmetrical corneal topography with corneal toricity <2.00 D in both eyes
- •Agree for randomization
排除标准
- •Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
- •Any type of strabismus or amblyopia
- •Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
- •Rigid contact lenses (including orthokeratology lenses) experience
- •Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
- •Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
- •Poor compliance for lens wear or follow-up
结局指标
主要结局
Axial length
时间窗: every 6 monthly in 2 years
axial progression of the eyeball
次要结局
- Choroidal thickness captured by Optical Coherent Tomographer (OCT)(every 6 monthly in 2 years)
- Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer(every 6 monthly in 2 years)
- Corneal biomechanics (corneal response using ocular response)(every 6 monthly in 2 years)
- Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer(every 6 monthly in 2 years)
研究者
Pauline Cho
Professor
The Hong Kong Polytechnic University
研究点 (1)
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