A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children
试验速览
- 阶段
- 2 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Spherical equivalent refraction determined by cycloplegic autorefraction
研究概览
简要总结
The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia.
详细描述
A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children
Study Duration and Visit Schedule Total of 5 years with 15 scheduled visits.
- Phase I: 2 years with 8 scheduled visits
- Phase II: 3 years with 7 scheduled visits
STUDY DESIGN This study consists of 2 phases, each with a different design. Phase I is a double-masked single-centre clinical trial wherein 400 children aged 6-12 years, with myopia of -2.00 D or worse in each eye, and from whom assent and parental/guardian consent have been obtained, will be randomised to receive 0.5% atropine, 0.1% atropine or 0.01% atropine once nightly in both eyes. Participants will be assigned to treatment in the ratio of 2:2:1, respectively. Each child will receive treatment for a period of 2 years during which they will be reviewed every 4 months.
Phase II is an open-label study wherein all children will continue to be followed-up regularly for changes in their refractive error after stopping atropine treatment. Those children who demonstrate myopia progression of -0.5 D or more, at least on one eye after a minimum of 8 months washout period will restart atropine treatment in both eyes. The appropriate dose will be determined by analysis of the data from Phase I of the study. Treatment will be for a further 2 years and all children, including those not receiving treatment, will be reviewed every 6 months.
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
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
- •Written Informed Consent from parent and assent from child has been obtained
- •Children aged 6 to 12 years
- •Refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction
- •Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
- •Astigmatism of less than or equal to -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction
- •Distance vision correctable to logMAR 0.2 or better in both eyes
- •A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D
- •Normal intraocular pressure of not greater than 21 mmHg
- •Normal ocular health other than myopia
- •In good general health with no history of cardiac or significant respiratory diseases
- •No asthma-requiring medications in the past one year
- •No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
- •Willing and able to comply with scheduled visits and other study procedures
排除标准
- •Ocular or systemic diseases which may affect vision or refractive error
- •Any ocular condition wherein topical atropine is contraindicated
- •Defective binocular function or stereopsis
- •Amblyopia or manifest strabismus including intermittent tropia
- •Previous or current use of atropine or pirenzepine
- •Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
结局指标
主要结局
Spherical equivalent refraction determined by cycloplegic autorefraction
次要结局
- Pupil reactivity and diameter assessment
- Axial length determined by non-contact partial coherence interferometry
- Ocular symptoms
- Induced cycloplegia assessed by near acuity and amplitude of accommodation tests
- Ocular surface and anterior segment changes assessed by slit-lamp and intraocular pressure assessed by non-contact tonometry
- Posterior segment changes assessed by fundus photography and ophthalmoscopy
- Retinal function assessed by distance acuity test and electroretinography