MyopiaPhase 3COMET2NCT00320593

Correction of Myopia Evaluation Trial 2

A Phase 3 study testing Progressive Addition Lenses (PALs) and Single Vision Lenses (SVLs) in people with Myopia, run by Jaeb Center for Health Research at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 8 to 11 years
Conditions the study is for: Myopia
What is being tested?: Progressive Addition Lenses (PALs) and Single Vision Lenses (SVLs)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 8 sitesUnited States
Study dates: Apr 2005to Mar 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Refractive error determined by cycloplegic autorefraction which meets all of the following:
Spherical equivalent: -0.50 to -3.00 D in both eyes
Astigmatism <= 1.5 D in both eyes
Anisometropia <= 1.00 D difference between eyes in spherical equivalent
Visual acuity is at least 20/20 with best subjective refraction in both eyes
Accommodative response at near (33 cm) is less than 2.0D by non-cycloplegic autorefraction
Near esophoria (>= 2.0 PD) present by alternate prism and cover test (APCT) at near using best refractive correction determined from non-cycloplegic subjective refraction

Who cannot join

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)

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Alabama- Birmingham, School of Optometry
Birmingham, Alabama, 35294
Indiana School of Optometry
Bloomington, Indiana, 47405
New England College of Optometry
Boston, Massachusetts, 02215-3468
Ohio State University College of Optometry
Columbus, Ohio, 43210-1280
Southern California College of Optometry
Fullerton, California, 92831-1699
University of Houston College of Optometry
Houston, Texas, 77204-2020
Family Eye Group
Lancaster, Pennsylvania, 17601
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141

Other trials in United States

About this study

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

Read the 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.

Conditions: Myopia
Being tested: Progressive Addition Lenses (PALs), Single Vision Lenses (SVLs)
Keywords: Myopia, Progressive Addition Lenses (PALs), Single Vision Lenses (SVLs), Accommodative lags, Near esophoria, Refractive error
Medical subject headings: Myopia, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Progressive Addition Lenses (PALs)Device
Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Single Vision Lenses (SVLs)Device
Single vision lenses

Study groups in NCT00320593
Study group	Role	What they receive
Progressive addition lenses (PALs)	Active comparator	Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition Receives: Device: Progressive Addition Lenses (PALs)
Single vision lenses (SVLs)	Active comparator	Single vision lenses Receives: Device: Single Vision Lenses (SVLs)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 3 years
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.
Measured: 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.
Measured: 3 years

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2005Mar 2010

First posted3 May 2006 (estimated)
Study startApr 2005
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00320593
Sponsor's protocol ID: NEI-123
Other IDs: 2U10EY011751, 5U10EY011751
Acronym: COMET2
Status last verified: Jul 2016
First submitted: 28 Apr 2006
Last updated: 9 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 19214130
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.
PubMed 21282579
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.
PubMed 36809645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00320593
Acronym / sponsor ID: COMET2 / NEI-123
Conditions: Myopia
Keywords: Myopia, Progressive Addition Lenses (PALs), Single Vision Lenses (SVLs), Accommodative lags, Near esophoria, Refractive error
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Jaeb Center for Health ResearchUniversity, hospital or other
Collaborators: National Eye Institute (NEI)
Study start: Apr 2005
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 3 May 2006 (estimated)
Results: Posted 21 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Screening consists of non-cycloplegic procedures of subjective refraction, testing of oculomotor alignment, and testing of accommodative response using the Grand Seiko autorefractor.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Progressive addition lenses (PALs)	Active comparator	Device: Progressive Addition Lenses (PALs)Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
Single vision lenses (SVLs)	Active comparator	Device: Single Vision Lenses (SVLs)Single vision lenses

Who may qualify

Ages: 8 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

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

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Progressive Addition Lenses (PALs)Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition	Device	Progressive addition lenses (PALs)
Single Vision Lenses (SVLs)Single vision lenses	Device	Single vision lenses (SVLs)

Primary outcome

Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
Time frame: Baseline to 3 years
Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years
Time frame: 3 years
Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Primary Outcome Measure Stratified by Sex
Time frame: 3 years
NIH-required analysis. Primary outcome measure (stratified by sex): Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Primary Outcome Measure Stratified by Race
Time frame: 3 years
NIH-required analysis. Primary outcome measure (stratified by race): Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.
Primary Outcome Measure Stratified by Ethnicity
Time frame: 3 years
NIH-required analysis. Primary outcome measure (stratified by ethnicity): Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.

7 secondary outcomes

Distribution of Spherical Equivalent Refractive Error at 3 Years
Time frame: 3 years
Mean Spherical Equivalent Refractive Error at 3 Years
Time frame: 3 years
Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Time frame: Baseline to 3 years
Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics
Time frame: Baseline to 3 years
Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year
Time frame: Baseline to 1 year
Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years
Time frame: Baseline to 2 years
Excellent Spectacle Compliance
Time frame: Baseline to 3 years

Results and safety

Results posted to the registry on 21 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Progressive Addition Lenses (PALs)	59	52
Single Vision Lenses (SVLs)	59	58

Primary outcome: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years

Time frame: Baseline to 3 years. Number. Unit: participants

Measure	Progressive Addition Lenses (PALs) n = 52	Single Vision Lenses (SVLs) n = 58
>0.00 D (less myopia)	6	3
0.00 to -0.49 D	11	8
-0.50 to -0.99 D	16	13
-1.00 to -1.49 D	12	13
<= -1.50 D (more myopia)	7	21

Population analysed: The analysis followed the intent-to-treat principle.

Primary outcome: Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years

Time frame: 3 years. Mean (Standard Deviation). Unit: diopters

Measure	Progressive Addition Lenses (PALs) n = 52	Single Vision Lenses (SVLs) n = 58
Value	-0.87 (0.72)	-1.15 (0.75)

Progressive Addition Lenses (PALs) vs Single Vision Lenses (SVLs): Mean Difference (Net): 0.28 (95% CI 0.01 to 0.55), ANCOVA
Progressive Addition Lenses (PALs) vs Single Vision Lenses (SVLs): Mean Difference (Net): 0.27 (95% CI 0.02 to 0.53), ANCOVA

Population analysed: 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.

Primary outcome: Primary Outcome Measure Stratified by Sex

Time frame: 3 years. Mean (Standard Deviation). Unit: diopters

Measure	Progressive Addition Lenses (PALs) n = 52	Single Vision Lenses (SVLs) n = 58
Female	-0.82 (0.76)	-1.21 (0.76)
Male	-0.95 (0.64)	-1.09 (0.75)

Primary outcome: Primary Outcome Measure Stratified by Race

Time frame: 3 years. Mean (Standard Deviation). Unit: diopters

Measure	Progressive Addition Lenses (PALs) n = 52	Single Vision Lenses (SVLs) n = 58
White	-0.81 (0.70)	-1.07 (0.72)
Black/African American	-0.79 (0.56)	-1.02 (0.60)
Asian	-1.85 (0.59)	-2.20 (0.76)
More than one race	-0.50 (0.13)	-0.62 (0.75)
Unknown/Not Reported	-0.10 (0.22)	-1.75 (0.08)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through the 3-year outcome visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Progressive Addition Lenses (PALs)	0 of 59 (0%)	0 of 59 (0%)	Not reported
Single Vision Lenses (SVLs)	0 of 59 (0%)	0 of 59 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19214130Correction 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.
Results publication: PubMed 21282579Correction 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.
Derived from this study: PubMed 36809645Lawrenson 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jane E Gwiazda, Ph.D. study chair

New England College of Optometry

Wendy L Marsh-Tootle principal investigator

University of Alabama at Birmingham School of Optometry

Ruth E Manny principal investigator

University of Houston College of Optometry

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Progressive Addition Lenses (PALs) and Single Vision Lenses (SVLs) in people with Myopia, run by Jaeb Center for Health Research at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (time frame: Baseline to 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00320593, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.