COMET2: Correction of Myopia Evaluation Trial 2

• Sponsor: Jaeb Center for Health Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00320593
• Collaborator: National Eye Institute (NEI) (NIH)
• Enrollment: 118
• Locations: 8
• Arms: 2
• Duration (Months): 59
• Patients Per Site: 14.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Progressive Addition Lenses (PALs); Device: Single Vision Lenses (SVLs)	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Correction of Myopia Evaluation Trial 2 (COMET2): A Randomized Trial of the Effect of Progressive Addition Lenses Versus Single Vision Lenses on Low Myopia Associated With Large Accommodative Lags and Near Esophoria in Children
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Progressive addition lenses (PALs) Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Device: Progressive Addition Lenses (PALs); Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Active Comparator: Single vision lenses (SVLs) Single vision lenses	Device: Single Vision Lenses (SVLs); Single vision lenses

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama- Birmingham, School of Optometry	Birmingham	Alabama	United States	35294
2	Southern California College of Optometry	Fullerton	California	United States	92831-1699
3	Indiana School of Optometry	Bloomington	Indiana	United States	47405
4	New England College of Optometry	Boston	Massachusetts	United States	02215-3468
5	Ohio State University College of Optometry	Columbus	Ohio	United States	43210-1280
6	Family Eye Group	Lancaster	Pennsylvania	United States	17601
7	Pennsylvania College of Optometry	Philadelphia	Pennsylvania	United States	19141
8	University of Houston College of Optometry	Houston	Texas	United States	77204-2020

Sponsors and Collaborators

• Jaeb Center for Health Research
• National Eye Institute (NEI)

Investigators

• Study Chair: Jane E Gwiazda, Ph.D., New England College of Optometry
• Principal Investigator: 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 School of Optometry
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaeb Center for Health Research
• ClinicalTrials.gov Identifier: NCT00320593
• Other Study ID Numbers: NEI-123; 2U10EY011751; 5U10EY011751
• First Posted: May 3, 2006
• Last Update Posted: Jul 19, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Jaeb Center for Health Research: Myopia; Progressive Addition Lenses (PALs); Single Vision Lenses (SVLs); Accommodative lags; Near esophoria; Refractive error
• Additional relevant MeSH terms: Myopia

Study Results

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.

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Period Title: Overall Study
STARTED	59	59
COMPLETED	52	58
NOT COMPLETED	7	1

Baseline Characteristics

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)	Total
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses	Total of all reporting groups
Overall Participants	59	59	118
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.2 (1.1)	10.0 (1.1)	10.1 (1.1)
Age, Customized (participants) [Number]
8 to <9 years	8 13.6%	14 23.7%	22 18.6%
9 to <10 years	15 25.4%	17 28.8%	32 27.1%
10 to <11 years	18 30.5%	14 23.7%	32 27.1%
11 to <12 years	18 30.5%	14 23.7%	32 27.1%
Sex: Female, Male (Count of Participants)
Female	36 61%	28 47.5%	64 54.2%
Male	23 39%	31 52.5%	54 45.8%
Race/Ethnicity, Customized (participants) [Number]
White	28 47.5%	31 52.5%	59 50%
African American	14 23.7%	10 16.9%	24 20.3%
Hispanic or Latino	10 16.9%	12 20.3%	22 18.6%
Asian	5 8.5%	4 6.8%	9 7.6%
Other	2 3.4%	2 3.4%	4 3.4%
Region of Enrollment (participants) [Number]
United States	59 100%	59 100%	118 100%
Spectacle wear (single vision lenses) (participants) [Number]
Currently	33 55.9%	33 55.9%	66 55.9%
In past but not currently	4 6.8%	2 3.4%	6 5.1%
Never	22 37.3%	24 40.7%	46 39%
Average Spherical Equivalent Between the Eyes (participants) [Number]
-0.75 to -0.99 diopters (D)	8 13.6%	12 20.3%	20 16.9%
-1.00 to -1.49 D	22 37.3%	23 39%	45 38.1%
-1.50 to -1.99 D	18 30.5%	14 23.7%	32 27.1%
-2.00 to -2.50 D	11 18.6%	10 16.9%	21 17.8%
Average Spherical Equivalent Between the Eyes (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	-1.50 (0.45)	-1.45 (0.47)	-1.48 (0.46)
Average J0 Between the Eyes (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	-0.02 (0.18)	-0.02 (0.15)	-0.02 (0.16)
Average J45 Between the Eyes (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	0.11 (0.07)	0.10 (0.07)	0.11 (0.07)
Anisometropia (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	0.22 (0.20)	0.21 (0.16)	0.22 (0.18)
Near Esophoria (participants) [Number]
2 to 5 prism diopters (PD)	33 55.9%	34 57.6%	67 56.8%
6 to 10 PD	22 37.3%	21 35.6%	43 36.4%
11 to 15 PD	3 5.1%	3 5.1%	6 5.1%
16 to 20 PD	1 1.7%	1 1.7%	2 1.7%
Near Esophoria (prism diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [prism diopters]	5.8 (3.2)	5.9 (3.4)	5.9 (3.3)
Accommodative Lag (participants) [Number]
0.50 to 0.99 diopters (D)	8 13.6%	6 10.2%	14 11.9%
1.00 to 1.49 D	26 44.1%	33 55.9%	59 50%
1.50 to 1.99 D	13 22%	16 27.1%	29 24.6%
2.00 D or more	12 20.3%	4 6.8%	16 13.6%
Accommodative Lag (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	1.47 (0.53)	1.40 (0.48)	1.44 (0.50)
Parental History of Myopia (participants) [Number]
Neither parent	10 16.9%	5 8.5%	15 12.7%
One parent	16 27.1%	10 16.9%	26 22%
Both parents	18 30.5%	20 33.9%	38 32.2%
Missing/unknown	15 25.4%	24 40.7%	39 33.1%

Outcome Measures

1. Secondary Outcome

Title	Distribution of Spherical Equivalent Refractive Error at 3 Years
Description	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

Outcome Measure Data

Analysis Population Description

The analysis followed the intent-to-treat principle.

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	52	58
Better than or equal to -0.49 D	0 0%	1 1.7%
-0.50 to -0.99 D	2 3.4%	1 1.7%
-1.00 to -1.99 D	18 30.5%	14 23.7%
-2.00 to -2.99 D	20 33.9%	21 35.6%
-3.00 to -3.99 D	8 13.6%	17 28.8%
Worse than or equal to -4.00 D	4 6.8%	4 6.8%

2. Primary Outcome

Title	Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
Description	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

Outcome Measure Data

Analysis Population Description

The analysis followed the intent-to-treat principle.

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	52	58
>0.00 D (less myopia)	6 10.2%	3 5.1%
0.00 to -0.49 D	11 18.6%	8 13.6%
-0.50 to -0.99 D	16 27.1%	13 22%
-1.00 to -1.49 D	12 20.3%	13 22%
<= -1.50 D (more myopia)	7 11.9%	21 35.6%

3. Secondary Outcome

Title	Mean Spherical Equivalent Refractive Error at 3 Years
Description	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

Outcome Measure Data

Analysis Population Description

The analysis followed the intent-to-treat principle.

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	52	58
Mean (Standard Deviation) [diopters]	-2.41 (0.95)	-2.60 (0.91)

4. Primary Outcome

Title	Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	52	58
Mean (Standard Deviation) [diopters]	-0.87 (0.72)	-1.15 (0.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Progressive Addition Lenses (PALs), Single Vision Lenses (SVLs)
	Comments	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%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 95%; 0.01 to 0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Progressive Addition Lenses (PALs), Single Vision Lenses (SVLs)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 95%; 0.02 to 0.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Description	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

Outcome Measure Data

Analysis Population Description

The analysis followed the intent-to-treat principle.

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	52	58
Age at baseline: 8 to <9 years	8 13.6%	13 22%
Age at baseline: 9 to <10 years	13 22%	17 28.8%
Age at baseline: 10 to <11 years	15 25.4%	14 23.7%
Age at baseline: 11 to <12 years	16 27.1%	14 23.7%
Gender: Male	19 32.2%	31 52.5%
Gender: Female	33 55.9%	27 45.8%
Race/Ethnicity: White	26 44.1%	30 50.8%
Race/Ethnicity: Nonwhite	26 44.1%	28 47.5%
Prior spectacle wear: Currently or in past	31 52.5%	34 57.6%
Prior spectacle wear: Never	21 35.6%	24 40.7%
Spherical equivalent at baseline: -0.75 to -1.49 D	25 42.4%	33 55.9%
Spherical equivalent at baseline: -1.50 to -2.50 D	27 45.8%	25 42.4%
Accommodative lag at baseline: 0.50 to 1.49 D	28 47.5%	38 64.4%
Accommodative lag at baseline: 1.50 or worse	24 40.7%	20 33.9%
Near esophoria at baseline: 2 to 5 PD	30 50.8%	33 55.9%
Near esophoria at baseline: 6 to 10 PD	18 30.5%	21 35.6%
Near esophoria at baseline: >10 PD	4 6.8%	4 6.8%
Parental history of myopia: Neither parent	9 15.3%	5 8.5%
Parental history of myopia: One parent	15 25.4%	10 16.9%
Parental history of myopia: Both parents	18 30.5%	20 33.9%

6. Secondary Outcome

Title	Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Description	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

Outcome Measure Data

Analysis Population Description

The analysis followed the intent-to-treat principle.

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	52	58
Age at baseline: 8 to <9 years	-1.23 (1.06)	-1.39 (0.79)
Age at baseline: 9 to <10 years	-1.11 (0.76)	-1.14 (0.78)
Age at baseline: 10 to <11 years	-0.71 (0.52)	-1.19 (0.81)
Age at baseline: 11 to <12 years	-0.64 (0.55)	-0.88 (0.58)
Gender: Male	-0.95 (0.64)	-1.09 (0.75)
Gender: Female	-0.82 (0.76)	-1.21 (0.76)
Race/Ethnicity: White	-0.79 (0.74)	-1.10 (0.76)
Race/Ethnicity: Nonwhite	-0.94 (0.70)	-1.19 (0.75)
Prior spectacle wear: Currently or in past	-0.90 (0.75)	-1.10 (0.63)
Prior spectacle wear: Never	-0.81 (0.68)	-1.22 (0.90)
Spherical equivalent at baseline: -0.75 to -1.49 D	-0.79 (0.61)	-1.20 (0.76)
Spherical equivalent at baseline: -1.50 to -2.50 D	-0.93 (0.81)	-1.08 (0.75)
Accommodative lag at baseline: 0.50 to 1.49 D	-0.91 (0.59)	-1.12 (0.72)
Accommodative lag at baseline: 1.50 or worse	-0.81 (0.86)	-1.20 (0.82)
Near esophoria at baseline: 2 to 5 PD	-0.97 (0.82)	-1.13 (0.79)
Near esophoria at baseline: 6 to 10 PD	-0.66 (0.54)	-1.09 (0.67)
Near esophoria at baseline: >10 PD	-1.01 (0.43)	-1.60 (0.86)
Parental history of myopia: Neither parent	-0.83 (0.63)	-0.72 (0.76)
Parental history of myopia: One parent	-0.73 (0.52)	-1.28 (0.62)
Parental history of myopia: Both parents	-0.99 (0.79)	-1.29 (0.87)

7. Secondary Outcome

Title	Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year
Description	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

Outcome Measure Data

Analysis Population Description

The analysis followed the intent-to-treat principle.

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	55	58
Mean (Standard Deviation) [diopters]	-0.29 (0.39)	-0.42 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Progressive Addition Lenses (PALs), Single Vision Lenses (SVLs)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.005 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years
Description	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

Outcome Measure Data

Analysis Population Description

The analysis followed the intent-to-treat principle

Arm/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	55	58
Mean (Standard Deviation) [diopters]	-0.58 (0.55)	-0.80 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Progressive Addition Lenses (PALs), Single Vision Lenses (SVLs)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95%; 0.02 to 0.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Excellent Spectacle Compliance
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Progressive Addition Lenses (PALs)	Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Standard single vision lenses
Measure Participants	58	58
During school	72 122%	90 152.5%
After school	60 101.7%	76 128.8%
Weekends	60 101.7%	71 120.3%

Adverse Events

Time Frame	Adverse events were collected through the 3-year outcome visit.
Arm/Group Title	Progressive Addition Lenses (PALs)		Single Vision Lenses (SVLs)
Arm/Group Description	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition		Standard single vision lenses
All Cause Mortality
	Progressive Addition Lenses (PALs)		Single Vision Lenses (SVLs)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Progressive Addition Lenses (PALs)		Single Vision Lenses (SVLs)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Progressive Addition Lenses (PALs)		Single Vision Lenses (SVLs)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.