Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in axial length in 2 years
研究概览
简要总结
This study was aimed to evaluate the effects of different Orthokeratology，including the size of central optical zone and the height of peripheral reverse curve, on myopia control and visual quality.
详细描述
This study was aimed to evaluate the effects of different Orthokeratology on myopia control and visual quality. The different optical zone of Orthokeratology lens was divided into 4 groups, ranged from 5.5 mm to 6 mm. And the control group subjects with the single glasses was included. The effectiveness of Orthokeratology was measured by axial length progression. The visual quality of subjects was evaluated by a questionnaire, contrast sensitivity and wavefront aberration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Myopia: between -1.00D and 4.00D in both eyes
- •Astigmatism: <1.5D for with-the-rule astigmatism, <1.00D for the against-the-rule astigmatism
- •Visual acuity: the best corrected vision acuity(BCVA)≥20/20 in both eyes
- •Subjects that volunteer to participate in the clinical trial and sign informed consent
排除标准
- •Contraindications of wearing Ortho-K.
- •Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
- •Any type of strabismus or amblyopia
- •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)
结局指标
主要结局
Changes in axial length in 2 years
时间窗: Every 6 months for a period 2 years
The axial length was measured by AL-scan
Changes in Cycloplegic subjective refraction in 2 years
时间窗: Every 6 months for a period 2 years
The cycloplegic subjective refraction was evaluated by optometrist
次要结局
- Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
- Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
- Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
- Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
- Change in Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
- Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
- Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
- Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
- Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）(baseline, postoperative 6 months, 12 months, 18 months and 24 months)
研究者
Shuxian zhang
Director
Tianjin Eye Hospital