Effectiveness of Orthokeratology and Peripheral Retinal Refraction Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Changes in axial length growth(ALG)
研究概览
简要总结
Orthokeratology (OK) has been demonstrated to be an effective intervention for slowing axial elongation in children with myopia. The proposed mechanism of action is the induction of peripheral myopic defocus, which reduces relative peripheral hyperopia on the retina.
This study aims to evaluate changes in relative peripheral retinal refraction before and after OK lens wear using wide-field multispectral retinal refractive topography. The study will also investigate the relationship between these retinal refractive changes and the effectiveness of OK in controlling axial elongation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8 to 15 years old
- •myopia of -4.00D or lower,
- •regular astigmatism ≤1.50D and non-regular astigmatism ≤1.00D
- •intraocular pressure ≤21mmHg
- •understand the purpose of the study and have good hygiene and regular follow-up
排除标准
- •unilateral
- •immunocompromised subjects with systemic diseases (such as acute or chronic sinusitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.)
- •complicated with other eye diseases that affect OK lens wearing, such as dacryocystitis, blepharitis and other inflammation, glaucoma, etc.
- •BCVA less than 1.0
- •children with corneal curvature less than 40.00D or higher than 46.00D.
结局指标
主要结局
Changes in axial length growth(ALG)
时间窗: Change from baseline in axial length at 12 months
Axial length will be measured using an ocular biometer (AL-Scan, NIDEK, Japan). Axial length growth (ALG) will be defined as the difference between the 1-year measurement and baseline.
次要结局
- Change in Relative Peripheral Retinal Refraction(Baseline (pre-lens wear), 1 month, 6 months, and 12 months after orthokeratology lens wear.)