Correction of Myopia Evaluation Trial 2 (COMET2): A Randomized Trial of the Effect of Progressive Addition Lenses Versus Single Vision Lenses on Low Myopia Associated With Large Accommodative Lags and Near Esophoria in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 15
- 主要终点
- Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
研究概览
简要总结
The purpose of the study is to determine if progressive addition lenses (PALs) versus single vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative responses (i.e., large accommodative lags) and near esophoria.
详细描述
Myopia is a significant public health problem that affects at least 34% of children in the United States and a much higher percentage in Asia. It is a predisposing factor for retinal detachment, myopic retinopathy, and glaucoma, thus contributing to loss of vision and blindness. As might be expected for such a prevalent condition, treatment costs are high. If interventions to retard myopia progression are successful, sight-threatening complications might be avoided and costs should be reduced.
The study has been designed as a simple trial that, other than the type of lenses being determined through the randomization process and the addition of accommodation testing using an autorefractor, largely approximates standard clinical practice.
Screening consists of non-cycloplegic procedures of subjective refraction, testing of oculomotor alignment, and testing of accommodative response using the Grand Seiko autorefractor.
Patients who appear to be eligible for the randomized trial will be tested with their eyes dilated to determine whether refractive error in each eye is within the eligibility range for the randomized trial. Patients will be randomized to either progressive addition lenses (PALs) with a +2.00 D addition or to single vision lenses (SVLs). Children will have three years of follow up, with visits every 6 months.
The primary outcome visit is timed 3 years from randomization, with the primary analysis being a comparison of the average change from baseline to 3 years in amount of myopia between children in the single-vision lens group and the children in the progressive-addition lens group. The primary outcome is change in spherical equivalent refractive error (SER) in diopters (D) as measured by cycloplegic autorefraction.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractive error determined by cycloplegic autorefraction which meets all of the following:
- •Spherical equivalent: -0.50 to -3.00 D in both eyes
- •Astigmatism <= 1.5 D in both eyes
- •Anisometropia <= 1.00 D difference between eyes in spherical equivalent
- •Visual acuity is at least 20/20 with best subjective refraction in both eyes
- •Accommodative response at near (33 cm) is less than 2.0D by non-cycloplegic autorefraction
- •Near esophoria (>= 2.0 PD) present by alternate prism and cover test (APCT) at near using best refractive correction determined from non-cycloplegic subjective refraction
排除标准
- •Strabismus present by cover-uncover test at far, near, and/or near with +2.00D over best subjective refraction
- •Current or prior use of PALs, bifocals, or contact lenses in either eye (prior or current use of SVLs is allowed)
研究组 & 干预措施
Progressive addition lenses (PALs)
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
干预措施: Progressive Addition Lenses (PALs) (Device)
Single vision lenses (SVLs)
Single vision lenses
干预措施: Single Vision Lenses (SVLs) (Device)
结局指标
主要结局
Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
时间窗: 3 years
Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
时间窗: Baseline to 3 years
Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Primary Outcome Measure Stratified by Sex
时间窗: 3 years
NIH-required analysis. Primary outcome measure (stratified by sex): Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Primary Outcome Measure Stratified by Race
时间窗: 3 years
NIH-required analysis. Primary outcome measure (stratified by race): Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Primary Outcome Measure Stratified by Ethnicity
时间窗: 3 years
NIH-required analysis. Primary outcome measure (stratified by ethnicity): Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
次要结局
- Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics(Baseline to 3 years)
- Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year(Baseline to 1 year)
- Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics(Baseline to 3 years)
- Distribution of Spherical Equivalent Refractive Error at 3 Years(3 years)
- Mean Spherical Equivalent Refractive Error at 3 Years(3 years)
- Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years(Baseline to 2 years)
- Excellent Spectacle Compliance(Baseline to 3 years)