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| ID | Type | Description | Link |
|---|---|---|---|
| 2U10EY011751 | U.S. NIH Grant/Contract | View source | |
| 5U10EY011751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive addition lenses (PALs) | Active Comparator | Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition |
|
| Single vision lenses (SVLs) | Active Comparator | Single vision lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Addition Lenses (PALs) | Device | Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 3 years |
| 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. | 3 years |
| Primary Outcome Measure Stratified by Sex | 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. | 3 years |
| Primary Outcome Measure Stratified by Race |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Refractive error determined by cycloplegic autorefraction which meets all of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jane E Gwiazda, Ph.D. | New England College of Optometry | Study Chair |
| Wendy L Marsh-Tootle | University of Alabama at Birmingham School of Optometry | Principal Investigator |
| Ruth E Manny | University of Houston College of Optometry | Principal Investigator |
| Erik M Weissberg | New England College of Optometry | Principal Investigator |
| David I Silbert | Family Eye Group | Principal Investigator |
| Don W Lyon | Indiana University | Principal Investigator |
| Mitchell M Scheiman | Pennsylvania College of Optometry | Principal Investigator |
| Marjean T Kulp | Ohio State University | Principal Investigator |
| Susan A Cotter | Southern California College of Optometry at Marshall B. Ketchum University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama- Birmingham, School of Optometry | Birmingham | Alabama | 35294 | United States | ||
| Southern California College of Optometry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19214130 | Result | Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group; Manny RE, Chandler DL, Scheiman MM, Gwiazda JE, Cotter SA, Everett DF, Holmes JM, Hyman LG, Kulp MT, Lyon DW, Marsh-Tootle W, Matta N, Melia BM, Norton TT, Repka MX, Silbert DI, Weissberg EM. Accommodative lag by autorefraction and two dynamic retinoscopy methods. Optom Vis Sci. 2009 Mar;86(3):233-43. doi: 10.1097/OPX.0b013e318197180c. | |
| 21282579 | Result |
Not provided
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Between April 2005 and March 2007, 118 subjects age 8 to <12 years were enrolled in the study at 8 clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Progressive Addition Lenses (PALs) | Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition |
| FG001 | Single Vision Lenses (SVLs) | Standard single vision lenses |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Progressive Addition Lenses (PALs) | Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition |
| BG001 | Single Vision Lenses (SVLs) | Standard single vision lenses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis followed the intent-to-treat principle. | Posted | Number | participants | 3 years |
|
Adverse events were collected through the 3-year outcome visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Progressive Addition Lenses (PALs) | Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition |
Not provided
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Limitations include: differential loss to follow up , differential compliance between the groups, power of near addition was not customized in PAL group, and we have no data on whether PAL group was looking through the near addition.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Kraker, MSPH | Jaeb Center for Health Research | 813-875-8690 | pedig@jaeb.org |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Single Vision Lenses (SVLs) | Device | Single vision lenses |
|
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.
| 3 years |
| Primary Outcome Measure Stratified by Ethnicity | 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. | 3 years |
| 3 years |
| 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. | 3 years |
| 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. | Baseline to 3 years |
| 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. | Baseline to 3 years |
| 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. | Baseline to 1 year |
| 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. | Baseline to 2 years |
| 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. | Baseline to 3 years |
| Fullerton |
| California |
| 92831-1699 |
| United States |
| Indiana School of Optometry | Bloomington | Indiana | 47405 | United States |
| New England College of Optometry | Boston | Massachusetts | 02215-3468 | United States |
| Ohio State University College of Optometry | Columbus | Ohio | 43210-1280 | United States |
| Family Eye Group | Lancaster | Pennsylvania | 17601 | United States |
| Pennsylvania College of Optometry | Philadelphia | Pennsylvania | 19141 | United States |
| University of Houston College of Optometry | Houston | Texas | 77204-2020 | United States |
| Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group. Progressive-addition lenses versus single-vision lenses for slowing progression of myopia in children with high accommodative lag and near esophoria. Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2749-57. doi: 10.1167/iovs.10-6631. |
| 36809645 | Derived | Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2. |
| Withdrawal by Subject |
|
| Withdrawal by clinical center |
|
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Age, Customized | Age at enrollment | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Spectacle wear (single vision lenses) | Number | participants |
|
| Average Spherical Equivalent Between the Eyes | Measured in diopters (D) using cycloplegic refraction sphere, cylinder and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Spherical equivalent is defined as the sphere plus 1/2 the cylinder. A spherical equivalent 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 spherical equivalent used for analysis. | Number | participants |
|
| Average Spherical Equivalent Between the Eyes | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Spherical equivalent is defined as the sphere plus 1/2 the cylinder. A spherical equivalent 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 spherical equivalent used for analysis. | Mean | Standard Deviation | diopters |
|
| Average J0 Between the Eyes | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). The dioptric power of a Jackson cross cylinder with axis at 0 degrees (J0) is calculated using the power vector approach. A J0 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 J0 used for analysis. | Mean | Standard Deviation | diopters |
|
| Average J45 Between the Eyes | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). The dioptric power of a Jackson cross cylinder with axis at 45 degrees (J45) is calculated using the power vector approach. A J45 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 J45 used for analysis. | Mean | Standard Deviation | diopters |
|
| Anisometropia | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Anisometropia is defined as spherical equivalent in the right eye subtracted by spherical equivalent in the left eye. | Mean | Standard Deviation | diopters |
|
| Near Esophoria | Measured in prism diopters (PD) using the Prism and Alternate Cover Test (PACT) at 33 cm. Esophoria is the tendency of the eyes to deviate inwards when fusion between the eyes is suspended. Near esophoria is an esophoria when viewing close objects. | Number | participants |
|
| Near Esophoria | Measured in prism diopters (PD) using the Prism and Alternate Cover Test (PACT) at 33 cm. Esophoria is the tendency of the eyes to deviate inwards when fusion between the eyes is suspended. Near esophoria is an esophoria when viewing close objects. | Mean | Standard Deviation | prism diopters |
|
| Accommodative Lag | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle (axis). Accommodative lag is the average of the median accommodative lag of the five trials of the right eye. To determine the accommodative lag or accommodative lead, the accommodative measurement was added to the 3.00-D demand to result in the accommodative lag or lead. If the value was positive, it indicated accommodative lag; if the number was negative, it indicated accommodative lead. | Number | participants |
|
| Accommodative Lag | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle (axis). Accommodative lag is the average of the median accommodative lag of the five trials of the right eye. To determine the accommodative lag or accommodative lead, the accommodative measurement was added to the 3.00-D demand to result in the accommodative lag or lead. If the value was positive, it indicated accommodative lag; if the number was negative, it indicated accommodative lead. | Mean | Standard Deviation | diopters |
|
| Parental History of Myopia | Number | participants |
|
Standard single vision lenses |
|
|
| 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. | The analysis followed the intent-to-treat principle. | Posted | Number | participants | Baseline to 3 years |
|
|
|
| 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. | The analysis followed the intent-to-treat principle. | Posted | Mean | Standard Deviation | diopters | 3 years |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | diopters | 3 years |
|
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|
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| 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. | The analysis followed the intent-to-treat principle. | Posted | Number | participants | Baseline to 3 years |
|
|
|
| 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. | The analysis followed the intent-to-treat principle. | Posted | Mean | Standard Deviation | diopters | Baseline to 3 years |
|
|
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| Primary | Primary Outcome Measure Stratified by Sex | 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. | 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. | Posted | Mean | Standard Deviation | diopters | 3 years |
|
|
|
| Primary | Primary Outcome Measure Stratified by Race | 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. | 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. | Posted | Mean | Standard Deviation | diopters | 3 years |
|
|
|
| Primary | Primary Outcome Measure Stratified by Ethnicity | 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. | 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. | Posted | Mean | Standard Deviation | diopters | 3 years |
|
|
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| 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. | The analysis followed the intent-to-treat principle. | Posted | Mean | Standard Deviation | diopters | Baseline to 1 year |
|
|
|
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| 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. | The analysis followed the intent-to-treat principle | Posted | Mean | Standard Deviation | diopters | Baseline to 2 years |
|
|
|
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| 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. | 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). | Posted | Number | percent of participants | Baseline to 3 years |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Single Vision Lenses (SVLs) | Standard single vision lenses | 0 | 59 | 0 | 59 |
Not provided
Not provided
| -0.50 to -0.99 D |
|
| -1.00 to -1.49 D |
|
| <= -1.50 D (more myopia) |
|
| 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. | ANCOVA | Mean Difference (Net) | 0.27 | 2-Sided | 95 | 0.02 | 0.53 | Superiority or Other |
| Age at baseline: 10 to <11 years |
|
| Age at baseline: 11 to <12 years |
|
| Gender: Male |
|
| Gender: Female |
|
| Race/Ethnicity: White |
|
| Race/Ethnicity: Nonwhite |
|
| Prior spectacle wear: Currently or in past |
|
| Prior spectacle wear: Never |
|
| Spherical equivalent at baseline: -0.75 to -1.49 D |
|
| Spherical equivalent at baseline: -1.50 to -2.50 D |
|
| Accommodative lag at baseline: 0.50 to 1.49 D |
|
| Accommodative lag at baseline: 1.50 or worse |
|
| Near esophoria at baseline: 2 to 5 PD |
|
| Near esophoria at baseline: 6 to 10 PD |
|
| Near esophoria at baseline: >10 PD |
|
| Parental history of myopia: Neither parent |
|
| Parental history of myopia: One parent |
|
| Parental history of myopia: Both parents |
|
| Age at baseline: 10 to <11 years |
|
| Age at baseline: 11 to <12 years |
|
| Gender: Male |
|
| Gender: Female |
|
| Race/Ethnicity: White |
|
| Race/Ethnicity: Nonwhite |
|
| Prior spectacle wear: Currently or in past |
|
| Prior spectacle wear: Never |
|
| Spherical equivalent at baseline: -0.75 to -1.49 D |
|
| Spherical equivalent at baseline: -1.50 to -2.50 D |
|
| Accommodative lag at baseline: 0.50 to 1.49 D |
|
| Accommodative lag at baseline: 1.50 or worse |
|
| Near esophoria at baseline: 2 to 5 PD |
|
| Near esophoria at baseline: 6 to 10 PD |
|
| Near esophoria at baseline: >10 PD |
|
| Parental history of myopia: Neither parent |
|
| Parental history of myopia: One parent |
|
| Parental history of myopia: Both parents |
|
| Male |
|
|
| Black/African American |
|
|
| Asian |
|
|
| More than one race |
|
|
| Unknown/Not Reported |
|
|
| Hispanic or Latino |
|
|
| Weekends |
|