Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Changes in cycloplegic refraction
研究概览
简要总结
The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.
详细描述
This study is a two-arm randomised controlled trial with a 18-month duration. Participants will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. Optical defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.
A total of 112 Hong Kong Chinese children aged 7 to 12 years (56 in each group) will be recruited and randomly allocated into two groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).
They must have no 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.
Their cycloplegic refraction and axial length will be monitored every six months for 18 months. 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 (Investigator, Outcomes Assessor)
盲法说明
Investigators, including ophthalmologists and optometrists, who are responsible for collection of data related to myopia progression and analysis of data will be blinded to study intervention.
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
- •Age at enrollment: 7 to 12 years
- •Ethnicity: Hong Kong Chinese
- •Myopia: -0.75D (in spherical equivalent) or above in both eyes
- •Astigmatism: -1.50D or less in both eyes
- •Anisometropia: 1.50D or less (in spherical equivalent) between two eyes
- •Best corrected monocular visual acuity (VA): 0.04 logMAR or better
- •Ocular health: No abnormalities in both internal and external ocular health
- •Systemic health: No abnormalities such as cardiac and respiratory diseases
- •Binocular vision: No strabismus, diplopia, suppression and other binocular abnormalities
- •Normal colour vision
- •No previous refractive surgery or use of myopic control interventions, such as atropine, orthokeratology, and specialized spectacle lenses and contact lenses for myopic control
- •Able to wear the prescribed spectacles
- •No known allergy to atropine
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
- •Colour vision deficiencies
- •Systemic disease that may affect vision, vision development (e.g. diabetes mellitus, hypertension, Down syndrome, etc.)
- •Systemic disease that are contradictory to atropine (e.g. asthma, cardiac diseases, etc.)
- •Previous gas permeable, soft bifocal, or orthokeratology contact lenses wear or bifocal / progressive addition lens spectacles wear or use of atropine or pirenzepine (longer than one month of usage)
- •Previous or current participation in myopia control studies
- •Allergy to cyclopentolate hydrochloride or atropine
研究组 & 干预措施
Low dose atropine plus DIMS
This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
干预措施: Defocus Incorporated Multiple Segments lenses (Device)
Low dose atropine plus DIMS
This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
干预措施: Low dose atropine (Drug)
Low dose atropine
This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and single vision spectacle lenses
干预措施: single vision spectacle lenses (Device)
Low dose atropine
This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and single vision spectacle lenses
干预措施: Low dose atropine (Drug)
结局指标
主要结局
Changes in cycloplegic refraction
时间窗: Baseline, 6th month, 12th month and 18th month
Changes in cycloplegic refraction in spherical equivalent (Dioptres) over 18 months from baseline will be measured.
Changes in axial length
时间窗: Baseline, 6th month, 12th month and 18th month
Changes in axial length (mm) over 18 months from baseline will be measured.
次要结局
未报告次要终点