Correction of Myopia Evaluation Trial 2 (COMET2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00320593
First received: April 28, 2006
Last updated: January 25, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

Publications:
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00320593     History of Changes
Other Study ID Numbers: NEI-123, 2U10EY011751, 5U10EY011751
Study First Received: April 28, 2006
Results First Received: May 17, 2011
Last Updated: January 25, 2012
Health Authority: United States: Federal Government

Keywords provided by Jaeb Center for Health Research:
Myopia
Progressive Addition Lenses (PALs)
Single Vision Lenses (SVLs)
Accommodative lags
Near esophoria
Refractive error

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014