MyopiaPhase 3NCT00000113
Correction of Myopia Evaluation Trial (COMET)
A Phase 3 study testing Progressive Addition Lenses and single vision lenses in people with Myopia, run by Stony Brook University at 4 sites in United States.
Trial summary
To evaluate whether progressive addition lenses (PALs) slow the rate of progression of juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by A-scan ultrasonography. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Progressive Addition Lenses and single vision lenses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 1997to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Children between the ages of 6 and 12 years with myopia in both eyes (defined as spherical equivalent between -1.25 D and -4.50 D in each eye as measured by cycloplegic autorefraction), astigmatism less than or equal to 1.50 D, and no anisometropia (defined as a difference in spherical equivalent between the two eyes greater than 1.0 D) are eligible for inclusion. Exclusion criteria include visual acuity greater than 20/25, strabismus, use of contact lenses, birth weight less than 1,250 grams, use of bifocal or progressive addition lenses, or any conditions precluding adherence to the protocol.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama-Birmingham, School of Optometry
Birmingham, Alabama, 35294-0010
New England College of Optometry
Boston, Massachusetts, 02115
University of Houston, College of Optometry
Houston, Texas, 77204-6052
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141-3399
About this study
To evaluate whether progressive addition lenses (PALs) slow the rate of progression of juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by A-scan ultrasonography.
To describe the natural history of juvenile-onset myopia in a group of children receiving conventional treatment (single vision lenses).
Read the detailed description
Myopia (nearsightedness) is an important public health problem, which entails substantial societal and personal costs. It is highly prevalent in our society and even more frequent in Asian countries; furthermore, its prevalence may be increasing over time. High myopia contributes to significant loss of vision and blindness. At present, the mechanisms involved in the etiology of myopia are unclear, and there is no way to prevent the condition. Current methods of correction require lifelong use of lenses or surgical treatment, which is expensive and may lead to complications. The rationale for this trial, the Correction of Myopia Evaluation Trial (COMET), arises from the convergence of research involving (1) the link between accommodation and myopia in children and (2) animal models of myopia showing the important role of the visual environment in eye growth. A contribution of this research is that blur is a critical component in the development of myopia. The primary aim of COMET, to evaluate the efficacy of progressive addition lenses, a noninvasive intervention, in slowing the progression of myopia, follows from this line of reasoning. These lenses should provide clear visual input over a range of viewing distances without focusing effort by the child. The comparison of myopia progression in children treated with PALs versus single vision lenses will allow the quantification of the effect of PALs on myopia progression during the followup period.
The COMET is a multicenter, randomized, double-masked clinical trial to evaluate whether PALs slow the progression of juvenile-onset myopia as compared with single vision lenses. The study is a collaborative effort that involves a Study Chair at the New England College of Optometry; four clinical centers at colleges of optometry in Boston, Birmingham, Philadelphia, and Houston; and a Coordinating Center at the State University of New York at Stony Brook.
The sample size goal, 450 children with myopia in both eyes who met specific inclusion and exclusion criteria, was attained with the enrollment of 469 children in one year. Children were identified from school screenings, clinic records, and referrals from local practitioners. Eligible children were randomly assigned to receive progressive addition or single vision lenses. Participating children are being examined at 6-month intervals following baseline, for at least 3 years, to measure changes in refractive error and to update prescriptions, according to a specified protocol. A dilated examination to evaluate the study outcome measures is performed at the annual study visits. A standardized, common protocol is used at all centers.
The primary outcome of the study is progression of myopia, defined as the magnitude of the change relative to baseline in spherical equivalent refraction, determined by cycloplegic autorefraction. The secondary outcome of the study is axial length measured by A-scan ultrasonography.
- Conditions
- Myopia
- Being tested
- Progressive Addition Lenses, single vision lenses
- Keywords
- myopia, nearsightedness
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Addition LensesOther
Varilux comfort with +2.00 addition
single vision lensesOther
| Study group | Role | What they receive |
|---|---|---|
| Progressive Addition Lenses (PALs) | Experimental | Not described Receives: Other: Progressive Addition Lenses |
| Single Vision Lenses | Active comparator | Not described Receives: Other: single vision lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of myopia, determined by cycloplegic autorefraction
Secondary outcomes (1)
Axial length measured by A-scan ultrasonography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startSep 1997
- Primary completionOct 2001
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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, Investigator, Outcomes assessor
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Investigators
- Jane Gwiazda, PhD, Study chair, New England College of OptometryLeslie Hyman, PhD, Study director, Stony Brook Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000113
- Sponsor's protocol ID
- NEI-9
- Other IDs
- U10EY011756
- Status last verified
- Apr 2016
- First submitted
- 23 Sep 1999
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.
PubMed 12657584Gwiazda JE, Hyman L, Norton TT, Hussein ME, Marsh-Tootle W, Manny R, Wang Y, Everett D; COMET Grouup. Accommodation and related risk factors associated with myopia progression and their interaction with treatment in COMET children. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2143-51. doi: 10.1167/iovs.03-1306.
PubMed 15223788Hyman L, Gwiazda J, Hussein M, Norton TT, Wang Y, Marsh-Tootle W, Everett D. Relationship of age, sex, and ethnicity with myopia progression and axial elongation in the correction of myopia evaluation trial. Arch Ophthalmol. 2005 Jul;123(7):977-87. doi: 10.1001/archopht.123.7.977.
PubMed 16009841Lawrenson 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 36809645Deng L, Gwiazda J, Manny RE, Scheiman M, Weissberg E, Fern KD, Weise K; COMET Study Group. Limited change in anisometropia and aniso-axial length over 13 years in myopic children enrolled in the Correction of Myopia Evaluation Trial. Invest Ophthalmol Vis Sci. 2014 Apr 3;55(4):2097-105. doi: 10.1167/iovs.13-13675.
PubMed 24576881Gwiazda J, Deng L, Manny R, Norton TT; COMET Study Group. Seasonal variations in the progression of myopia in children enrolled in the correction of myopia evaluation trial. Invest Ophthalmol Vis Sci. 2014 Feb 4;55(2):752-8. doi: 10.1167/iovs.13-13029.
PubMed 24408976
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Myopia Evaluation Trial (COMET)
- ClinicalTrials.gov ID
- NCT00000113
- Acronym / sponsor ID
- NEI-9
- Conditions
- Myopia
- Keywords
- myopia, nearsightedness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Sep 1997
- Primary completion
- Oct 2001 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether progressive addition lenses (PALs) slow the rate of progression of juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by A-scan ultrasonography.
To describe the natural history of juvenile-onset myopia in a group of children receiving conventional treatment (single vision lenses).
Detailed description
Myopia (nearsightedness) is an important public health problem, which entails substantial societal and personal costs. It is highly prevalent in our society and even more frequent in Asian countries; furthermore, its prevalence may be increasing over time. High myopia contributes to significant loss of vision and blindness. At present, the mechanisms involved in the etiology of myopia are unclear, and there is no way to prevent the condition. Current methods of correction require lifelong use of lenses or surgical treatment, which is expensive and may lead to complications. The rationale for this trial, the Correction of Myopia Evaluation Trial (COMET), arises from the convergence of research involving (1) the link between accommodation and myopia in children and (2) animal models of myopia showing the important role of the visual environment in eye growth. A contribution of this research is that blur is a critical component in the development of myopia. The primary aim of COMET, to evaluate the efficacy of progressive addition lenses, a noninvasive intervention, in slowing the progression of myopia, follows from this line of reasoning. These lenses should provide clear visual input over a range of viewing distances without focusing effort by the child. The comparison of myopia progression in children treated with PALs versus single vision lenses will allow the quantification of the effect of PALs on myopia progression during the followup period.
The COMET is a multicenter, randomized, double-masked clinical trial to evaluate whether PALs slow the progression of juvenile-onset myopia as compared with single vision lenses. The study is a collaborative effort that involves a Study Chair at the New England College of Optometry; four clinical centers at colleges of optometry in Boston, Birmingham, Philadelphia, and Houston; and a Coordinating Center at the State University of New York at Stony Brook.
The sample size goal, 450 children with myopia in both eyes who met specific inclusion and exclusion criteria, was attained with the enrollment of 469 children in one year. Children were identified from school screenings, clinic records, and referrals from local practitioners. Eligible children were randomly assigned to receive progressive addition or single vision lenses. Participating children are being examined at 6-month intervals following baseline, for at least 3 years, to measure changes in refractive error and to update prescriptions, according to a specified protocol. A dilated examination to evaluate the study outcome measures is performed at the annual study visits. A standardized, common protocol is used at all centers.
The primary outcome of the study is progression of myopia, defined as the magnitude of the change relative to baseline in spherical equivalent refraction, determined by cycloplegic autorefraction. The secondary outcome of the study is axial length measured by A-scan ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Addition Lenses (PALs) | Experimental | Other: Progressive Addition Lenses |
| Single Vision Lenses | Active comparator | Other: single vision lenses |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 LensesVarilux comfort with +2.00 addition | Other | Progressive Addition Lenses (PALs) |
| single vision lenses | Other | Single Vision Lenses |
Primary outcome
Progression of myopia, determined by cycloplegic autorefraction
1 secondary outcome
Axial length measured by A-scan ultrasonography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Results publication: PubMed 12657584Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.
- Results publication: PubMed 15223788Gwiazda JE, Hyman L, Norton TT, Hussein ME, Marsh-Tootle W, Manny R, Wang Y, Everett D; COMET Grouup. Accommodation and related risk factors associated with myopia progression and their interaction with treatment in COMET children. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2143-51. doi: 10.1167/iovs.03-1306.
- Results publication: PubMed 16009841Hyman L, Gwiazda J, Hussein M, Norton TT, Wang Y, Marsh-Tootle W, Everett D. Relationship of age, sex, and ethnicity with myopia progression and axial elongation in the correction of myopia evaluation trial. Arch Ophthalmol. 2005 Jul;123(7):977-87. doi: 10.1001/archopht.123.7.977.
- 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.
- Derived from this study: PubMed 24576881Deng L, Gwiazda J, Manny RE, Scheiman M, Weissberg E, Fern KD, Weise K; COMET Study Group. Limited change in anisometropia and aniso-axial length over 13 years in myopic children enrolled in the Correction of Myopia Evaluation Trial. Invest Ophthalmol Vis Sci. 2014 Apr 3;55(4):2097-105. doi: 10.1167/iovs.13-13675.
- Derived from this study: PubMed 24408976Gwiazda J, Deng L, Manny R, Norton TT; COMET Study Group. Seasonal variations in the progression of myopia in children enrolled in the correction of myopia evaluation trial. Invest Ophthalmol Vis Sci. 2014 Feb 4;55(2):752-8. doi: 10.1167/iovs.13-13029.
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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 Gwiazda, PhD study chair
New England College of Optometry
Leslie Hyman, PhD study director
Stony Brook Medicine
4 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 and single vision lenses in people with Myopia, run by Stony Brook University at 4 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?
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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression of myopia, determined by cycloplegic autorefraction. 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 NCT00000113, which also lists 6 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 15 Apr 2016.