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Trial NCT00000113

Resource URI: http://static.linkedct.org/resource/trials/NCT00000113
linkedct:brief_title Correction of Myopia Evaluation Trial (COMET)
linkedct:condition <http://static.linkedct.org/resource/condition/8512>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 12 Years
linkedct:eligibility_minimum_age 6 Years
linkedct:end_date September 1998
linkedct:enrollment 450 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:id NCT00000113
rdfs:label Trial NCT00000113
linkedct:lastchanged_date September 16, 2009
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:location <http://static.linkedct.org/resource/location/147744>
linkedct:location <http://static.linkedct.org/resource/location/160823>
linkedct:location <http://static.linkedct.org/resource/location/177904>
linkedct:location <http://static.linkedct.org/resource/location/202704>
linkedct:nct_id NCT00000113
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Correction of Myopia Evaluation Trial (COMET)
linkedct:org_study_id NEI-9
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/25701>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000113>
linkedct:phase Phase 3
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16964>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/3123>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/12084>
linkedct:source National Eye Institute (NEI)
linkedct:start_date September 1997
linkedct:study_design Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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).
rdf:type linkedct:trials
linkedct:verification_date September 2009