Exploring the Effects of Treatment With Stellest Lenses and Low-concentration Atropine for Myopia Control Among Children.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Spherical equivalent refraction power
研究概览
简要总结
The prevalence of myopia is increasing globally, especially in Asian countries. 70-80% of the young population suffers from myopia, and almost 20% have high myopia. High myopia can easily lead to blinding diseases, including retinal detachment, macular degeneration, and glaucoma. In Taiwan, according to a survey by the National Health Administration, the proportion of myopia among Grade 1 students has exceeded 81%.
There are many ways to control myopia progression. High concentrations of atropine have been reported highly effective in the control of the myopia progression. However the accompanied side effects such as photophobia and near blurred vision. Recent research shows that low-concentration atropine can achieve similar control effect and more acceptable with much minimal side effect compared to high concentration of atropine.
Multiple animal experiments have confirmed that giving retinal myopia defocus signals can effectively decrease the growth of the eye, thereby inhibiting the progression of myopia. Therefore, regarding lens design, myopic defocus does play an important role in myopia control, including orthokeratology lenses, multifocal soft contact lenses, and peripheral defocus lenses.
Stellest, a myopia control lens based on the myopia defocus theory, is equipped with highly aspheric lenslet technology. In a recent study, compared with single vision lenses, Stellest significantly slowed down the myopia progression reaching 67% and retard axial elongation reaching 64% The purpose of this study is to explore the effectiveness of Stellest Lenses in controlling myopia in Taiwanese children and whether Stellest Lenses combined with low-concentration atropine eye drops can increase the effect of myopia control.
详细描述
The prevalence of myopia has been increasing in the world, especially in East Asia. The prevalence of myopia and high myopia is estimated up to 50% and 10% of the global population, respectively in 2050. The social economic burden of this myopia epidemic will increase substantially, because of the risk of myopia-related complications, such as early onset of cataract, glaucoma, myopic macular degeneration and retinal detachment. The use of myopia control interventions in school myopia can help reduce severity of myopia in the further life of this population with potential reduce of the risk of these pathologies.
There are several ways to control school myopia progression. High concentrations of atropine have been reported highly effective in the control of the myopia progression. However the accompanied side effects such as photophobia and near blurred vision. Recent research shows that low-concentration atropine can achieve similar control effect and more acceptable with much minimal side effect compared to high concentration of atropine.
Research in animal models has shown that imposed myopic optical defocus in peripheral retina, the focal plane in front of the retina, has an inhibitory effect on eye growth to stop myopia progression. Recently, it has been reported that spectacle lenses with aspherical lenslets with myopic defocus (Stellest™ lenses) effectively slow myopia progression reaching 67% and retard axial elongation reaching 64% compared with single vision lenes in 1 year study.
The purpose of this study is to compare the effect of the Stellest lenses, 0.05% atropine and combined treatment for the myopia control in Taiwanese children.
Method： This study will be conducted 2 years at the Kaohsiung Chang Gung Memorial Hospital, Taiwan. Children aged 6 to 12 years old with myopic refraction of at least -0.75 D in both eyes, astigmatism of less than -2.5 D, were enrolled in this open label, randomized study. Excluded were those with ocular diseases (e.g., cataract, congenital retinal diseases, amblyopia, and strabismus), previous use of atropine, or orthokeratology lens orother optical methods for myopia control within 6 months, allergy to atropine, or systemic diseases (e.g., endocrine, cardiac, and respiratory diseases). Written informed consent will be obtained from parents or guardians and the participants. The study will be sent to the Ethics Committee of the Chang Gung Memorial Hospital and will be registered with the ClinicalTrials.gov Registry, the Kaohsiung Chang Gung Memorial Hospital (registration no:). All procedures are conducted according to the tenets of the Declaration of Helsinki.
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 (Participant)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6~12 year-old.
- •Equivalent diopter: -0.75~-4.00 D.
- •Astigmatism and anisometropia <2.50 D.
- •Best corrected visual acuity of one eye reaches 1.0.
排除标准
- •Strabismus, amblyopia, and abnormal binocular vision.
- •Other eye diseases.
- •Have a history of using myopia control products within six months.
研究组 & 干预措施
Stellest lenses spectacle
34 children wear Stellest lenses for all day.
干预措施: Stellest Lenses (Device)
Stellest lenses+0.05% atropine
33 children wear Stellest lenses for all day, and 0.05% atropine eye drops is dropped once nightly in both eyes.
干预措施: Stellest Lenses+0.05% atropine (Combination Product)
Single vision lenses+0.05% atropine
33 children wear Single lenses for all day, and 0.05% atropine eye drops is dropped once nightly in both eyes.
干预措施: Single vision Lenses+0.05% atropine (Drug)
结局指标
主要结局
Spherical equivalent refraction power
时间窗: At 2 weeks (monitor visit), 6 months, and 12 months from the baseline visit
Spherical equivalent (SE) was calculated as spherical power plus half of the cylinder power
Axial length
时间窗: At 2 weeks (monitor visit), 6 months, and 12 months from the baseline visit
Ocular AL was measured by on non contact partial coherence interferometry and optic coherence tomography.
次要结局
未报告次要终点