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Correction of Myopia Evaluation Trial 2 (COMET2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320593
First Posted: May 3, 2006
Last Update Posted: July 19, 2016
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.
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
  Purpose
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 Intervention Phase
Myopia Device: Progressive Addition Lenses (PALs) Device: Single Vision Lenses (SVLs) Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Distribution of Spherical Equivalent Refractive Error at 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. 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.

  • Mean Spherical Equivalent Refractive Error at 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. 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.

  • Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics [ 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 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.

  • Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics [ 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 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.

  • Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year [ Time Frame: 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.

  • Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years [ Time Frame: 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.

  • Excellent Spectacle Compliance [ Time Frame: 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.


Enrollment: 118
Study Start Date: April 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320593


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