Myopia
Conditions
Keywords
Myopia, Progressive Addition Lenses (PALs), Single Vision Lenses (SVLs), Accommodative lags, Near esophoria, Refractive error
Brief summary
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.
Detailed description
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. A separate ancillary study nested within the screening process will collect data on two additional methods of measuring accommodation, Monocular Estimate Method (MEM) retinoscopy and Nott retinoscopy. The aim of the ancillary study to help determine whether a simple, effective measure exists that can be easily used by clinicians to identify children with reduced accommodative response who, if they have low myopia and esophoria, might benefit from the treatment with PALs.
Interventions
DEVICEProgressive Addition Lenses (PALs)
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Single vision lenses
Sponsors
Jaeb Center for Health Research
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Refractive error determined by cycloplegic autorefraction which meets all of the following: 1. Spherical equivalent: -0.50 to -3.00 D in both eyes 2. Astigmatism \<= 1.5 D in both eyes 3. 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | 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. |
| Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | 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. |
| Primary Outcome Measure Stratified by Sex | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Spherical Equivalent Refractive Error at 3 Years | 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. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis. |
| Mean Spherical Equivalent Refractive Error at 3 Years | 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. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis. |
| Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | 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 defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, 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. |
| Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | 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 defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, 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. |
| Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year | Baseline to 1 year | 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 1 year, 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 1 year. A negative value indicates that the myopia worsened; a positive value indicates that it improved. |
| Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years | Baseline to 2 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 2 years, 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 2 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved. |
| Excellent Spectacle Compliance | Baseline to 3 years | Spectacle compliance was assessed on a five-point Likert scale: always, 5; often, 4; sometimes, 3; rarely, 2; and never, 1. Excellent compliance indicates that for the specified period (during school, after school, on weekends), spectacles were estimated at all visits to have been worn either always or often. |
Countries
United States
Contacts
STUDY_CHAIRJane E Gwiazda, Ph.D.
New England College of Optometry
PRINCIPAL_INVESTIGATORWendy L Marsh-Tootle
University of Alabama at Birmingham School of Optometry
PRINCIPAL_INVESTIGATORRuth E Manny
University of Houston College of Optometry
PRINCIPAL_INVESTIGATORErik M Weissberg
New England College of Optometry
PRINCIPAL_INVESTIGATORDavid I Silbert
Family Eye Group
PRINCIPAL_INVESTIGATORDon W Lyon
Indiana University
PRINCIPAL_INVESTIGATORMitchell M Scheiman
Pennsylvania College of Optometry
PRINCIPAL_INVESTIGATORMarjean T Kulp
Ohio State University
PRINCIPAL_INVESTIGATORSusan A Cotter
Southern California College of Optometry at Marshall B. Ketchum University
Participant flow
Recruitment details
Between April 2005 and March 2007, 118 subjects age 8 to \<12 years were enrolled in the study at 8 clinical centers.
Participants by arm
| Arm | Count |
|---|---|
| Progressive Addition Lenses (PALs) Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition | 59 |
| Single Vision Lenses (SVLs) Standard single vision lenses | 59 |
| Total | 118 |
Baseline characteristics
| Characteristic | Progressive Addition Lenses (PALs) | Total | Single Vision Lenses (SVLs) |
|---|---|---|---|
| Accommodative Lag 0.50 to 0.99 diopters (D) | 8 participants | 14 participants | 6 participants |
| Accommodative Lag 1.00 to 1.49 D | 26 participants | 59 participants | 33 participants |
| Accommodative Lag 1.50 to 1.99 D | 13 participants | 29 participants | 16 participants |
| Accommodative Lag 2.00 D or more | 12 participants | 16 participants | 4 participants |
| Accommodative Lag | 1.47 diopters STANDARD_DEVIATION 0.53 | 1.44 diopters STANDARD_DEVIATION 0.5 | 1.40 diopters STANDARD_DEVIATION 0.48 |
| Age, Continuous | 10.2 years STANDARD_DEVIATION 1.1 | 10.1 years STANDARD_DEVIATION 1.1 | 10.0 years STANDARD_DEVIATION 1.1 |
| Age, Customized 10 to <11 years | 18 participants | 32 participants | 14 participants |
| Age, Customized 11 to <12 years | 18 participants | 32 participants | 14 participants |
| Age, Customized 8 to <9 years | 8 participants | 22 participants | 14 participants |
| Age, Customized 9 to <10 years | 15 participants | 32 participants | 17 participants |
| Anisometropia | 0.22 diopters STANDARD_DEVIATION 0.2 | 0.22 diopters STANDARD_DEVIATION 0.18 | 0.21 diopters STANDARD_DEVIATION 0.16 |
| Average J0 Between the Eyes | -0.02 diopters STANDARD_DEVIATION 0.18 | -0.02 diopters STANDARD_DEVIATION 0.16 | -0.02 diopters STANDARD_DEVIATION 0.15 |
| Average J45 Between the Eyes | 0.11 diopters STANDARD_DEVIATION 0.07 | 0.11 diopters STANDARD_DEVIATION 0.07 | 0.10 diopters STANDARD_DEVIATION 0.07 |
| Average Spherical Equivalent Between the Eyes -0.75 to -0.99 diopters (D) | 8 participants | 20 participants | 12 participants |
| Average Spherical Equivalent Between the Eyes -1.00 to -1.49 D | 22 participants | 45 participants | 23 participants |
| Average Spherical Equivalent Between the Eyes -1.50 to -1.99 D | 18 participants | 32 participants | 14 participants |
| Average Spherical Equivalent Between the Eyes -2.00 to -2.50 D | 11 participants | 21 participants | 10 participants |
| Average Spherical Equivalent Between the Eyes | -1.50 diopters STANDARD_DEVIATION 0.45 | -1.48 diopters STANDARD_DEVIATION 0.46 | -1.45 diopters STANDARD_DEVIATION 0.47 |
| Near Esophoria 11 to 15 PD | 3 participants | 6 participants | 3 participants |
| Near Esophoria 16 to 20 PD | 1 participants | 2 participants | 1 participants |
| Near Esophoria 2 to 5 prism diopters (PD) | 33 participants | 67 participants | 34 participants |
| Near Esophoria 6 to 10 PD | 22 participants | 43 participants | 21 participants |
| Near Esophoria | 5.8 prism diopters STANDARD_DEVIATION 3.2 | 5.9 prism diopters STANDARD_DEVIATION 3.3 | 5.9 prism diopters STANDARD_DEVIATION 3.4 |
| Parental History of Myopia Both parents | 18 participants | 38 participants | 20 participants |
| Parental History of Myopia Missing/unknown | 15 participants | 39 participants | 24 participants |
| Parental History of Myopia Neither parent | 10 participants | 15 participants | 5 participants |
| Parental History of Myopia One parent | 16 participants | 26 participants | 10 participants |
| Race/Ethnicity, Customized African American | 14 participants | 24 participants | 10 participants |
| Race/Ethnicity, Customized Asian | 5 participants | 9 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 participants | 22 participants | 12 participants |
| Race/Ethnicity, Customized Other | 2 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized White | 28 participants | 59 participants | 31 participants |
| Region of Enrollment United States | 59 participants | 118 participants | 59 participants |
| Sex: Female, Male Female | 36 Participants | 64 Participants | 28 Participants |
| Sex: Female, Male Male | 23 Participants | 54 Participants | 31 Participants |
| Spectacle wear (single vision lenses) Currently | 33 participants | 66 participants | 33 participants |
| Spectacle wear (single vision lenses) In past but not currently | 4 participants | 6 participants | 2 participants |
| Spectacle wear (single vision lenses) Never | 22 participants | 46 participants | 24 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
Primary
Distribution of Change in Spherical Equivalent Refractive Error From 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.
Time frame: Baseline to 3 years
Population: The analysis followed the intent-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | 0.00 to -0.49 D | 11 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | -1.00 to -1.49 D | 12 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | -0.50 to -0.99 D | 16 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | <= -1.50 D (more myopia) | 7 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | >0.00 D (less myopia) | 6 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | <= -1.50 D (more myopia) | 21 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | >0.00 D (less myopia) | 3 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | 0.00 to -0.49 D | 8 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | -0.50 to -0.99 D | 13 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | -1.00 to -1.49 D | 13 participants |
Primary
Mean Change in Spherical Equivalent Refractive Error From 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 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.
Time frame: 3 years
Population: All analyses followed the intent-to-treat principle. The Monte Carlo Markov Chain (MCMC) method of multiple imputation was used to impute data for subjects who did not complete the 3-year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | -0.87 diopters | Standard Deviation 0.72 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years | -1.15 diopters | Standard Deviation 0.75 |
Comparison: The primary analysis was a comparison of treatment groups using an analysis of covariance (ANCOVA) model in which myopia at 3 years was adjusted for myopia at baseline and prior SVL wear. The sample size was computed to reach a 90% power and type I error rate of 5%, so that a difference in 3-year myopia progression between treatment groups would be detected if the true difference was at least 0.60 D, assuming a standard deviation of 0.85 D in each group and loss of follow up of 10%.95% CI: [0.01, 0.55]ANCOVA
Comparison: An adjusted analysis for the treatment group difference of change in spherical equivalent from baseline to 3 years was performed by including in an analysis of covariance (ANCOVA) model the following covariates in addition to baseline myopia and prior single vision lens wear, which are known to be related to myopia progression: age, sex, ethnicity, accommodative lag, and magnitude of near esophoria.95% CI: [0.02, 0.53]ANCOVA
Secondary
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
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 3 years, 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.
Time frame: Baseline to 3 years
Population: The analysis followed the intent-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Gender: Female | 33 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 8 to <9 years | 8 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Race/Ethnicity: White | 26 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Spherical equivalent at baseline: -1.50 to -2.50 D | 27 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Prior spectacle wear: Never | 21 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Accommodative lag at baseline: 0.50 to 1.49 D | 28 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 9 to <10 years | 13 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Accommodative lag at baseline: 1.50 or worse | 24 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Prior spectacle wear: Currently or in past | 31 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: 2 to 5 PD | 30 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: 6 to 10 PD | 18 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 10 to <11 years | 15 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: >10 PD | 4 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Spherical equivalent at baseline: -0.75 to -1.49 D | 25 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: Neither parent | 9 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 11 to <12 years | 16 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: One parent | 15 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Race/Ethnicity: Nonwhite | 26 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: Both parents | 18 participants |
| Progressive Addition Lenses (PALs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Gender: Male | 19 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: Both parents | 20 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Race/Ethnicity: White | 30 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Race/Ethnicity: Nonwhite | 28 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: 2 to 5 PD | 33 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Prior spectacle wear: Currently or in past | 34 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Prior spectacle wear: Never | 24 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Spherical equivalent at baseline: -0.75 to -1.49 D | 33 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 8 to <9 years | 13 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 9 to <10 years | 17 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 10 to <11 years | 14 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 11 to <12 years | 14 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Gender: Female | 27 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Spherical equivalent at baseline: -1.50 to -2.50 D | 25 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Accommodative lag at baseline: 0.50 to 1.49 D | 38 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Accommodative lag at baseline: 1.50 or worse | 20 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: 6 to 10 PD | 21 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: >10 PD | 4 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: Neither parent | 5 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: One parent | 10 participants |
| Single Vision Lenses (SVLs) | Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Gender: Male | 31 participants |
Secondary
Distribution of Spherical Equivalent Refractive Error at 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. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.
Time frame: 3 years
Population: The analysis followed the intent-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Progressive Addition Lenses (PALs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | -2.00 to -2.99 D | 20 participants |
| Progressive Addition Lenses (PALs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | Better than or equal to -0.49 D | 0 participants |
| Progressive Addition Lenses (PALs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | -0.50 to -0.99 D | 2 participants |
| Progressive Addition Lenses (PALs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | -1.00 to -1.99 D | 18 participants |
| Progressive Addition Lenses (PALs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | -3.00 to -3.99 D | 8 participants |
| Progressive Addition Lenses (PALs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | Worse than or equal to -4.00 D | 4 participants |
| Single Vision Lenses (SVLs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | -3.00 to -3.99 D | 17 participants |
| Single Vision Lenses (SVLs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | -2.00 to -2.99 D | 21 participants |
| Single Vision Lenses (SVLs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | -1.00 to -1.99 D | 14 participants |
| Single Vision Lenses (SVLs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | Better than or equal to -0.49 D | 1 participants |
| Single Vision Lenses (SVLs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | Worse than or equal to -4.00 D | 4 participants |
| Single Vision Lenses (SVLs) | Distribution of Spherical Equivalent Refractive Error at 3 Years | -0.50 to -0.99 D | 1 participants |
Secondary
Excellent Spectacle Compliance
Spectacle compliance was assessed on a five-point Likert scale: always, 5; often, 4; sometimes, 3; rarely, 2; and never, 1. Excellent compliance indicates that for the specified period (during school, after school, on weekends), spectacles were estimated at all visits to have been worn either always or often.
Time frame: Baseline to 3 years
Population: The analysis followed the intent-to-treat principle. Two patients had no compliance data because they had no follow-up visits (one single vision lenses, and one progressive-addition lenses).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Progressive Addition Lenses (PALs) | Excellent Spectacle Compliance | During school | 72 percent of participants |
| Progressive Addition Lenses (PALs) | Excellent Spectacle Compliance | After school | 60 percent of participants |
| Progressive Addition Lenses (PALs) | Excellent Spectacle Compliance | Weekends | 60 percent of participants |
| Single Vision Lenses (SVLs) | Excellent Spectacle Compliance | During school | 90 percent of participants |
| Single Vision Lenses (SVLs) | Excellent Spectacle Compliance | After school | 76 percent of participants |
| Single Vision Lenses (SVLs) | Excellent Spectacle Compliance | Weekends | 71 percent of participants |
Secondary
Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year
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 1 year, 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 1 year. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Time frame: Baseline to 1 year
Population: The analysis followed the intent-to-treat principle.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year | -0.29 diopters | Standard Deviation 0.39 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year | -0.42 diopters | Standard Deviation 0.37 |
Comparison: A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 1 year, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 1 year, in which myopia at 1 year was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 1 year values were known) were included.95% CI: [-0.005, 0.28]ANCOVA
Secondary
Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 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 2 years, 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 2 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Time frame: Baseline to 2 years
Population: The analysis followed the intent-to-treat principle
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years | -0.58 diopters | Standard Deviation 0.55 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years | -0.80 diopters | Standard Deviation 0.61 |
Comparison: A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 2 years, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 2 years, in which myopia at 2 years was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 2 year values were known) were included.95% CI: [0.02, 0.45]ANCOVA
Secondary
Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
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 3 years, 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.
Time frame: Baseline to 3 years
Population: The analysis followed the intent-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 10 to <11 years | -0.71 diopters | Standard Deviation 0.52 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Spherical equivalent at baseline: -0.75 to -1.49 D | -0.79 diopters | Standard Deviation 0.61 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Gender: Female | -0.82 diopters | Standard Deviation 0.76 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 9 to <10 years | -1.11 diopters | Standard Deviation 0.76 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Spherical equivalent at baseline: -1.50 to -2.50 D | -0.93 diopters | Standard Deviation 0.81 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Accommodative lag at baseline: 0.50 to 1.49 D | -0.91 diopters | Standard Deviation 0.59 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Race/Ethnicity: White | -0.79 diopters | Standard Deviation 0.74 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Accommodative lag at baseline: 1.50 or worse | -0.81 diopters | Standard Deviation 0.86 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 11 to <12 years | -0.64 diopters | Standard Deviation 0.55 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: 2 to 5 PD | -0.97 diopters | Standard Deviation 0.82 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Race/Ethnicity: Nonwhite | -0.94 diopters | Standard Deviation 0.7 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: 6 to 10 PD | -0.66 diopters | Standard Deviation 0.54 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: >10 PD | -1.01 diopters | Standard Deviation 0.43 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 8 to <9 years | -1.23 diopters | Standard Deviation 1.06 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: Neither parent | -0.83 diopters | Standard Deviation 0.63 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Prior spectacle wear: Currently or in past | -0.90 diopters | Standard Deviation 0.75 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: One parent | -0.73 diopters | Standard Deviation 0.52 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Gender: Male | -0.95 diopters | Standard Deviation 0.64 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: Both parents | -0.99 diopters | Standard Deviation 0.79 |
| Progressive Addition Lenses (PALs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Prior spectacle wear: Never | -0.81 diopters | Standard Deviation 0.68 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: Both parents | -1.29 diopters | Standard Deviation 0.87 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 8 to <9 years | -1.39 diopters | Standard Deviation 0.79 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 9 to <10 years | -1.14 diopters | Standard Deviation 0.78 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 10 to <11 years | -1.19 diopters | Standard Deviation 0.81 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Age at baseline: 11 to <12 years | -0.88 diopters | Standard Deviation 0.58 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Gender: Male | -1.09 diopters | Standard Deviation 0.75 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Gender: Female | -1.21 diopters | Standard Deviation 0.76 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Race/Ethnicity: White | -1.10 diopters | Standard Deviation 0.76 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Race/Ethnicity: Nonwhite | -1.19 diopters | Standard Deviation 0.75 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Prior spectacle wear: Currently or in past | -1.10 diopters | Standard Deviation 0.63 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Prior spectacle wear: Never | -1.22 diopters | Standard Deviation 0.9 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Spherical equivalent at baseline: -1.50 to -2.50 D | -1.08 diopters | Standard Deviation 0.75 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Spherical equivalent at baseline: -0.75 to -1.49 D | -1.20 diopters | Standard Deviation 0.76 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Accommodative lag at baseline: 0.50 to 1.49 D | -1.12 diopters | Standard Deviation 0.72 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Accommodative lag at baseline: 1.50 or worse | -1.20 diopters | Standard Deviation 0.82 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: 2 to 5 PD | -1.13 diopters | Standard Deviation 0.79 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: >10 PD | -1.60 diopters | Standard Deviation 0.86 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: Neither parent | -0.72 diopters | Standard Deviation 0.76 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Parental history of myopia: One parent | -1.28 diopters | Standard Deviation 0.62 |
| Single Vision Lenses (SVLs) | Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics | Near esophoria at baseline: 6 to 10 PD | -1.09 diopters | Standard Deviation 0.67 |
Secondary
Mean Spherical Equivalent Refractive Error at 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. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.
Time frame: 3 years
Population: The analysis followed the intent-to-treat principle.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progressive Addition Lenses (PALs) | Mean Spherical Equivalent Refractive Error at 3 Years | -2.41 diopters | Standard Deviation 0.95 |
| Single Vision Lenses (SVLs) | Mean Spherical Equivalent Refractive Error at 3 Years | -2.60 diopters | Standard Deviation 0.91 |