Clinical Trial: Correction of Myopia Evaluation Trial (COMET)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Correction of Myopia Evaluation Trial (COMET)

Brief 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.

To describe the natural history of juvenile-onset myopia in a group of children receiving conventional treatment (single vision lenses).

Detailed Summary:

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
Sponsor: Stony Brook University

Current Primary Outcome: Progression of myopia, determined by cycloplegic autorefraction

Original Primary Outcome:

Current Secondary Outcome: Axial length measured by A-scan ultrasonography

Original Secondary Outcome:

Information By: Stony Brook University

Dates:
Date Received: September 23, 1999
Date Started: September 1997
Date Completion:
Last Updated: April 14, 2016
Last Verified: April 2016