NCT07142915尚未招募不适用
A Prospective Randomized Controlled Trial on the Effect of Light-Blocking Lenses on Emmetropization in Hyperopic Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Axial length
研究概览
简要总结
This study aims to assess the efficacy of light-blocking lenses in facilitating emmetropization in children with hyperopia and to explore their influence on various aspects of visual function.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6 years or older and 12 years or younger;
- •Spherical refractive error in both eyes between +3.0 D and +7.5 D, cylindrical refractive error between -2.0 D and 0 D; interocular difference in spherical power less than 1.5 D and in cylindrical power no greater than 1.0 D;
- •Best-corrected visual acuity of 0.0 logMAR or better in both eyes;
- •Ocular deviation with spectacles less than 10 prism diopters;
- •Has been wearing standard single-vision spectacles regularly for more than six months;
- •In good general health, capable of receiving the study intervention, and willing to comply with the study protocol;
- •Written informed consent obtained from both the parent/guardian and the child, with agreement to comply with all study procedures and maintain follow-up availability throughout the study period;
排除标准
- •History of ocular trauma or eye surgery;
- •Presence of pathological abnormalities on anterior or posterior segment examination, or a history of organic ocular diseases such as cataract, glaucoma, corneal disease, or fundus disorders;
- •Intraocular pressure greater than 21 mmHg;
- •Presence of systemic diseases or other conditions deemed unsuitable for study participation;
- •Any other condition deemed inappropriate for participation in the clinical trial by the investigator;
结局指标
主要结局
Axial length
时间窗: At baseline, 6 months, and 12 months
measured by optical biometer
次要结局
- Refractive error(At baseline, 6 months, and 12 months)
- Best-corrected visual acuity(At baseline, 6 months, and 12 months)
- Intraocular pressure(At baseline, 6 months, and 12 months)
- Angle of deviation(At baseline, 6 months, and 12 months)
- Contrast sensitivity(At baseline, 6 months, and 12 months)
- Stereopsis(At baseline, 6 months, and 12 months)
- Accommodative function(At baseline, 6 months, and 12 months)
- Intervention questionnaire(At baseline, 6 months, and 12 months)
研究者
Jingrong Li
Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University
研究点 (2)
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