Correction of Myopia Evaluation Trial (COMET)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000113
• Date of registration: 23/09/1999
• Primary sponsor: National Eye Institute (NEI)
• Public title: Correction of Myopia Evaluation Trial (COMET)
• Scientific title: Correction of Myopia Evaluation Trial (COMET)
• Date of first enrolment: September 1997
• Target sample size: 450
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000113
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jane Gwiazda, PhD
• Affiliation: New England College of Optometry

Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Myopia

Intervention(s)

Device: Progressive Addition Lenses

Primary Outcome(s)

Progression of myopia, determined by cycloplegic autorefraction

Secondary Outcome(s)

Axial length measured by A-scan ultrasonography

Secondary ID(s)

NEI-9

Source(s) of Monetary Support

Please refer to primary and secondary sponsors