Correction of Myopia Evaluation Trial (COMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000113
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : April 15, 2016
National Eye Institute (NEI)
Information provided by:
Stony Brook University

September 23, 1999
September 24, 1999
April 15, 2016
September 1997
October 2001   (Final data collection date for primary outcome measure)
Progression of myopia, determined by cycloplegic autorefraction
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Complete list of historical versions of study NCT00000113 on Archive Site
Axial length measured by A-scan ultrasonography
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Correction of Myopia Evaluation Trial (COMET)
Correction of Myopia Evaluation Trial (COMET)

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).

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Other: Progressive Addition Lenses
    Varilux comfort with +2.00 addition
  • Other: single vision lenses
  • Experimental: Progressive Addition Lenses (PALs)
    Intervention: Other: Progressive Addition Lenses
  • Active Comparator: Single Vision Lenses
    Intervention: Other: single vision lenses

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2013
October 2001   (Final data collection date for primary outcome measure)
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.
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
U10EY011756 ( U.S. NIH Grant/Contract )
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Stony Brook University
National Eye Institute (NEI)
Study Chair: Jane Gwiazda, PhD New England College of Optometry
Study Director: Leslie Hyman, PhD Stony Brook Medicine
Stony Brook University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP