Correction of Myopia Evaluation Trial (COMET)

This study has been completed.
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00000113
First received: September 23, 1999
Last updated: March 23, 2010
Last verified: September 2009
  Purpose

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).


Condition Intervention Phase
Myopia
Device: Progressive Addition Lenses
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Correction of Myopia Evaluation Trial (COMET)

Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • Progression of myopia, determined by cycloplegic autorefraction

Secondary Outcome Measures:
  • Axial length measured by A-scan ultrasonography

Estimated Enrollment: 450
Study Start Date: September 1997
Study Completion Date: September 1998
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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000113

Locations
United States, Alabama
University of Alabama-Birmingham, School of Optometry
Birmingham, Alabama, United States, 35294-0010
United States, Massachusetts
New England College of Optometry
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141-3399
United States, Texas
University of Houston, College of Optometry
Houston, Texas, United States, 77204-6052
Sponsors and Collaborators
Investigators
Study Chair: Jane Gwiazda, PhD New England College of Optometry
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00000113     History of Changes
Other Study ID Numbers: NEI-9
Study First Received: September 23, 1999
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Eye Institute (NEI):
myopia
nearsightedness

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014