Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 23
- 主要终点
- Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
研究概览
简要总结
Study Objectives
The objectives for this randomized trial are:
- To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment).
- To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).
Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
详细描述
Study Objectives
The objectives for this randomized trial are:
- To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years with myopia -1.00 to -6.00D at the time of enrollment (Primary Outcome On-Treatment).
- To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).
Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Cycloplegic autorefraction, axial length, and additional biometry will be measured by a masked examiner at all follow-up visits using the same instrumentation on the participant throughout the study. Masking will be accomplished by having site personnel administer cyclopentolate to both eyes of each participant and wait 30 minutes before he/she sees the masked examiner. The masked examiner may be a technician or an investigator and must be certified to complete these measurements. Parents, patients, and investigators are also masked to treatment.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.
- •Refractive error meeting the following by cycloplegic autorefraction:
- •Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
- •Astigmatism <=1.50D in both eyes
- •Anisometropia <1.00D SE
- •Gestational age ≥ 32 weeks.
- •Birth weight >1500g.
- •Parent understands the protocol and is willing to accept randomization to atropine or placebo.
- •Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops.
- •Able to return in 2 to 4 weeks for possible randomization.
- •Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff.
- •Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated.
排除标准
- •Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
- •Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
- •Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
- •Known atropine allergy.
- •Abnormality of the cornea, lens, central retina, iris or ciliary body.
- •Current or prior history of manifest strabismus, amblyopia, or nystagmus.
- •Prior eyelid, strabismus, intraocular, or refractive surgery.
- •Down syndrome or cerebral palsy.
- •Females who are pregnant, lactating, or intending to become pregnant within the next 30 months.
- •A negative urine pregnancy test will be required for all females who have experienced menarche.
研究组 & 干预措施
Placebo Group
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
干预措施: Placebo Eyedrops (Other)
Atropine Group
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
干预措施: Atropine (Drug)
结局指标
主要结局
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
时间窗: At 24 months
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Primary Outcome Measure Stratified by Sex
时间窗: at 24 months
NIH-required analysis. Primary outcome measure (stratified by sex): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Primary Outcome Measure Stratified by Race
时间窗: by 24 months
NIH-required analysis. Primary outcome measure (stratified by race): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Primary Outcome Measure Stratified by Ethnicity
时间窗: at 24 months
NIH-required analysis. Primary outcome measure (stratified by ethnicity): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Primary Outcome: Mean Change in Spherical Equivalent Refractive Error at 24 Months
时间窗: 24 months
The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.
次要结局
- Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent(At 30 months)