Trial Outcomes & Findings for Correction of Myopia Evaluation Trial 2 (NCT NCT00320593)
NCT ID: NCT00320593
Last Updated: 2016-07-19
Results Overview
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.
COMPLETED
PHASE3
118 participants
Baseline to 3 years
2016-07-19
Participant Flow
Between April 2005 and March 2007, 118 subjects age 8 to \<12 years were enrolled in the study at 8 clinical centers.
Participant milestones
| Measure |
Progressive Addition Lenses (PALs)
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
Standard single vision lenses
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
52
|
58
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
Progressive Addition Lenses (PALs)
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
Standard single vision lenses
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Moved to another state
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Withdrawal by clinical center
|
1
|
0
|
Baseline Characteristics
Correction of Myopia Evaluation Trial 2
Baseline characteristics by cohort
| Measure |
Progressive Addition Lenses (PALs)
n=59 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=59 Participants
Standard single vision lenses
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.2 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
10.0 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
10.1 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Age, Customized
8 to <9 years
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Age, Customized
9 to <10 years
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Age, Customized
10 to <11 years
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Age, Customized
11 to <12 years
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
59 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Spectacle wear (single vision lenses)
Currently
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Spectacle wear (single vision lenses)
In past but not currently
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Spectacle wear (single vision lenses)
Never
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Average Spherical Equivalent Between the Eyes
-0.75 to -0.99 diopters (D)
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Average Spherical Equivalent Between the Eyes
-1.00 to -1.49 D
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Average Spherical Equivalent Between the Eyes
-1.50 to -1.99 D
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Average Spherical Equivalent Between the Eyes
-2.00 to -2.50 D
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Average Spherical Equivalent Between the Eyes
|
-1.50 diopters
STANDARD_DEVIATION 0.45 • n=5 Participants
|
-1.45 diopters
STANDARD_DEVIATION 0.47 • n=7 Participants
|
-1.48 diopters
STANDARD_DEVIATION 0.46 • n=5 Participants
|
|
Average J0 Between the Eyes
|
-0.02 diopters
STANDARD_DEVIATION 0.18 • n=5 Participants
|
-0.02 diopters
STANDARD_DEVIATION 0.15 • n=7 Participants
|
-0.02 diopters
STANDARD_DEVIATION 0.16 • n=5 Participants
|
|
Average J45 Between the Eyes
|
0.11 diopters
STANDARD_DEVIATION 0.07 • n=5 Participants
|
0.10 diopters
STANDARD_DEVIATION 0.07 • n=7 Participants
|
0.11 diopters
STANDARD_DEVIATION 0.07 • n=5 Participants
|
|
Anisometropia
|
0.22 diopters
STANDARD_DEVIATION 0.20 • n=5 Participants
|
0.21 diopters
STANDARD_DEVIATION 0.16 • n=7 Participants
|
0.22 diopters
STANDARD_DEVIATION 0.18 • n=5 Participants
|
|
Near Esophoria
2 to 5 prism diopters (PD)
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Near Esophoria
6 to 10 PD
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Near Esophoria
11 to 15 PD
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Near Esophoria
16 to 20 PD
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Near Esophoria
|
5.8 prism diopters
STANDARD_DEVIATION 3.2 • n=5 Participants
|
5.9 prism diopters
STANDARD_DEVIATION 3.4 • n=7 Participants
|
5.9 prism diopters
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Accommodative Lag
0.50 to 0.99 diopters (D)
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Accommodative Lag
1.00 to 1.49 D
|
26 participants
n=5 Participants
|
33 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Accommodative Lag
1.50 to 1.99 D
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Accommodative Lag
2.00 D or more
|
12 participants
n=5 Participants
|
4 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Accommodative Lag
|
1.47 diopters
STANDARD_DEVIATION 0.53 • n=5 Participants
|
1.40 diopters
STANDARD_DEVIATION 0.48 • n=7 Participants
|
1.44 diopters
STANDARD_DEVIATION 0.50 • n=5 Participants
|
|
Parental History of Myopia
Neither parent
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Parental History of Myopia
One parent
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Parental History of Myopia
Both parents
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Parental History of Myopia
Missing/unknown
|
15 participants
n=5 Participants
|
24 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 yearsPopulation: The analysis followed the intent-to-treat principle.
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=52 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
0.00 to -0.49 D
|
11 participants
|
8 participants
|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
-0.50 to -0.99 D
|
16 participants
|
13 participants
|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
-1.00 to -1.49 D
|
12 participants
|
13 participants
|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
<= -1.50 D (more myopia)
|
7 participants
|
21 participants
|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
>0.00 D (less myopia)
|
6 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=52 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
|
-0.87 diopters
Standard Deviation 0.72
|
-1.15 diopters
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The analysis followed the intent-to-treat principle.
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=52 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
Distribution of Spherical Equivalent Refractive Error at 3 Years
-3.00 to -3.99 D
|
8 participants
|
17 participants
|
|
Distribution of Spherical Equivalent Refractive Error at 3 Years
-2.00 to -2.99 D
|
20 participants
|
21 participants
|
|
Distribution of Spherical Equivalent Refractive Error at 3 Years
Better than or equal to -0.49 D
|
0 participants
|
1 participants
|
|
Distribution of Spherical Equivalent Refractive Error at 3 Years
-0.50 to -0.99 D
|
2 participants
|
1 participants
|
|
Distribution of Spherical Equivalent Refractive Error at 3 Years
Worse than or equal to -4.00 D
|
4 participants
|
4 participants
|
|
Distribution of Spherical Equivalent Refractive Error at 3 Years
-1.00 to -1.99 D
|
18 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The analysis followed the intent-to-treat principle.
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=52 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
Mean Spherical Equivalent Refractive Error at 3 Years
|
-2.41 diopters
Standard Deviation 0.95
|
-2.60 diopters
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline to 3 yearsPopulation: The analysis followed the intent-to-treat principle.
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=52 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Gender: Male
|
19 participants
|
31 participants
|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Gender: Female
|
33 participants
|
27 participants
|
|
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
|
13 participants
|
|
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
|
17 participants
|
|
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
|
14 participants
|
|
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
|
14 participants
|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Race/Ethnicity: White
|
26 participants
|
30 participants
|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Race/Ethnicity: Nonwhite
|
26 participants
|
28 participants
|
|
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
|
34 participants
|
|
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Prior spectacle wear: Never
|
21 participants
|
24 participants
|
|
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
|
33 participants
|
|
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
|
25 participants
|
|
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
|
38 participants
|
|
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
|
20 participants
|
|
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
|
33 participants
|
|
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
|
21 participants
|
|
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
|
4 participants
|
|
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
|
5 participants
|
|
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
|
10 participants
|
|
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
|
20 participants
|
SECONDARY outcome
Timeframe: Baseline to 3 yearsPopulation: The analysis followed the intent-to-treat principle.
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=52 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
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
|
-1.39 diopters
Standard Deviation 0.79
|
|
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
|
-1.14 diopters
Standard Deviation 0.78
|
|
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
|
-1.19 diopters
Standard Deviation 0.81
|
|
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
|
-0.88 diopters
Standard Deviation 0.58
|
|
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
|
-1.09 diopters
Standard Deviation 0.75
|
|
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
|
-1.21 diopters
Standard Deviation 0.76
|
|
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
|
-1.10 diopters
Standard Deviation 0.76
|
|
Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Race/Ethnicity: Nonwhite
|
-0.94 diopters
Standard Deviation 0.70
|
-1.19 diopters
Standard Deviation 0.75
|
|
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
|
-1.10 diopters
Standard Deviation 0.63
|
|
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
|
-1.22 diopters
Standard Deviation 0.90
|
|
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
|
-1.20 diopters
Standard Deviation 0.76
|
|
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
|
-1.08 diopters
Standard Deviation 0.75
|
|
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
|
-1.12 diopters
Standard Deviation 0.72
|
|
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
|
-1.20 diopters
Standard Deviation 0.82
|
|
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
|
-1.13 diopters
Standard Deviation 0.79
|
|
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
|
-1.09 diopters
Standard Deviation 0.67
|
|
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
|
-1.60 diopters
Standard Deviation 0.86
|
|
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
|
-0.72 diopters
Standard Deviation 0.76
|
|
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
|
-1.28 diopters
Standard Deviation 0.62
|
|
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
|
-1.29 diopters
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: The analysis followed the intent-to-treat principle.
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=55 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year
|
-0.29 diopters
Standard Deviation 0.39
|
-0.42 diopters
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: The analysis followed the intent-to-treat principle
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=55 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years
|
-0.58 diopters
Standard Deviation 0.55
|
-0.80 diopters
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Baseline to 3 yearsPopulation: 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).
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.
Outcome measures
| Measure |
Progressive Addition Lenses (PALs)
n=58 Participants
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
|
Single Vision Lenses (SVLs)
n=58 Participants
Standard single vision lenses
|
|---|---|---|
|
Excellent Spectacle Compliance
During school
|
72 percent of participants
|
90 percent of participants
|
|
Excellent Spectacle Compliance
After school
|
60 percent of participants
|
76 percent of participants
|
|
Excellent Spectacle Compliance
Weekends
|
60 percent of participants
|
71 percent of participants
|
Adverse Events
Progressive Addition Lenses (PALs)
Single Vision Lenses (SVLs)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place