Effectiveness of Bright Light Therapy, Myopic Defocus, Atropine and the Combinations for Controlling Myopic Eye Growth in Schoolchildren: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- Cycloplegic Refraction Change in spherical equivalent refraction (SER)
研究概览
简要总结
The purpose of the study is to investigate the effect of bright light therapy, myopic defocus, atropine and the combination in myopia control in schoolchildren.
详细描述
The present study is a multi-arm randomised clinical trial with a 24-month duration. Subjects will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aims are to determine the clinical effectiveness of bright light therapy on inhibiting myopia progression in schoolchildren, and to determine whether combination therapy using bright light therapy (BLT) and myopic defocus is more effective than monotherapy.
Study population Seven hundred and sixty Hong Kong Chinese children (152 in each) of A. Control group, B. BLT only group, C. BLT and Defocus Incorporated Multiple Segments (DIMS) group, D. BLT and atropine 0.01% group) and E. Atropine 0.01% group aged 7-12 years old will be recruited. They must not have had prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. They must not have allergy to atropine.
The eligible subjects will be randomly assigned into one of the four groups. Their cycloplegic refraction and axial length will be monitored every six months for 2 years. The changes in refractive errors and axial length between groups will be compared.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Myopia of at least -0.75D (spherical equivalent) in both eyes
- •Age at enrolment: 7-12 year; Hong Kong Chinese
- •Astigmatism and anisometropia: 1.50D or less
- •Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
- •Parents' understanding and acceptance of random allocation of grouping and masking
- •Able to wear the prescribed spectacle, put on eye drop and undergo light therapy daily.
排除标准
- •Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
- •Previous intraocular or corneal surgery
- •Systemic disease that may affect vision, vision development (e.g. endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
- •Allergy to atropine
- •Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL/specific myopic control spectacle wear or use of atropine or pirenzepine (longer than 1 month of wear)
- •Previous or current participation in myopia control studies
研究组 & 干预措施
Control
Subjects in control will receive single vision spectacle lenses and a placebo desk lamp
BLT monotherapy
Subjects in BLT monotherapy group will receive a high intensity light box for bright light therapy and single vision spectacle lenses
干预措施: High intensity light box for bright light therapy and single vision spectacle lenses (Other)
BLT and DIMS
Subjects in BLT and DIMS group will receive a high intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
干预措施: High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses (Other)
BLT and atropine
Subjects in BLT and atropine group will receive a high intensity light box for bright light therapy, single vision spectacle lens, and atropine 0.01% eye drop (twice a day)
干预措施: High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses (Other)
Atropine monotherapy
Subjects in atropine group will receive atropine 0.01% eye drop (twice a day) and single vision spectacle lenses
干预措施: Atropine 0.01% eye drop and and single vision spectacle lenses (Other)
结局指标
主要结局
Cycloplegic Refraction Change in spherical equivalent refraction (SER)
时间窗: Baseline and 2 years
Change in cycloplegic SER (in diopter) will be measured using an open field autorefractor
次要结局
- Axial length(Baseline and 2 years)