Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 5
- 主要终点
- Near viewing duration
研究概览
简要总结
Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. One possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. This study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. The outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6 to below 14 years old
- •Spherical equivalent myopic refractive error greater than -0.50 D
- •Best corrected logMAR visual acuity of 0.1 or better in each eye for 6- to 14-year-old children, and 0.2 logMAR or better than in each eye for 4 and 5-year-old children (adjusted for age-related expectations)
- •Good ocular and general health that would not preclude them from myopia control
- •Competent enough in English to fully understand the participant information and consent form
- •Willing to undergo treatment to slow myopia progression for one year
排除标准
- •Strabismus at distance or near, or amblyopia
- •Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis)
- •Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision
- •Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development
- •Child, parents or guardians not willing to comply with treatment and/or follow-up schedule and planning to migrate or move during the one-year study duration
结局指标
主要结局
Near viewing duration
时间窗: 12 months
Duration during near tasks
Near viewing distance
时间窗: 12 months
Distance during near tasks
Outdoor time
时间窗: 12 months
Ambient illumination to determine time spent outdoors
次要结局
- Objective cycloplegic central refraction(12 months)
- Axial length(12 months)
- Subjective cycloplegic central refraction(12 months)
研究者
Pauline Kang
Senior Lecturer
The University of New South Wales