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.
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
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.
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
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Jane E Gwiazda, Ph.D., Study chair, New England College of OptometryWendy L Marsh-Tootle, Principal investigator, University of Alabama at Birmingham School of OptometryRuth E Manny, Principal investigator, University of Houston College of OptometryErik M Weissberg, Principal investigator, New England College of OptometryDavid I Silbert, Principal investigator, Family Eye GroupDon W Lyon, Principal investigator, Indiana UniversityMitchell M Scheiman, Principal investigator, Pennsylvania College of OptometryMarjean T Kulp, Principal investigator, Ohio State University
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 19214130Correction 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 21282579Lawrenson 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