This proposal is for the New England College of Optometry (NEWENCO) to serve as a clinical center in the Correction of Myopia Evaluation Trial (COMET). COMET is a prospective, randomized clinical trial designed to assess whether progressive addition lenses (PALs) slow the progression of juvenile-onset myopia, compared to conventional single vision lenses (SV). Seven hundred fifty children 6-12 years old with myopia (-1.25 to -4.5 D) in both eyes, who meet specific inclusion criteria and lack specific exclusion criteria will be enrolled. They will be identified primarily from elementary school vision screenings. All eligible children will be examined at baseline and at six-month intervals for at least three years of follow up to measure changes in refractive error and to update prescriptions. A standardized, common protocol will be used at all four centers. The primary outcome measure is progression of myopia, as measured by cycloplegic autorefraction. An additional outcome measure is axial elongation as measured by A-scan ultrasonography. These will be obtained by masked examiners. This application documents the ability of NEWENCO to screen about 7700 children for possible eligibility, to recruit at least 188 children within one academic year and to retain them for at least three years of follow up. Documentation is also provided that NEWENCO has the personnel, equipment, and facilities to conduct the study in accordance with the COMET Manual of Procedures (MOP). Complete details of the COMET rationale, design, and methods are contained in the MOP, which is submitted separately with the study chair and coordinating center applications. In addition to NEWENCO, the other clinical centers are located at Colleges of Optometry in Birmingham, Houston, and Philadelphia, with the Study Chair in Boston and the Coordinating Center at Stony Brook, NY.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY011752-08
Application #
6875561
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Everett, Donald F
Project Start
1997-03-01
Project End
2008-02-28
Budget Start
2005-03-01
Budget End
2006-02-28
Support Year
8
Fiscal Year
2005
Total Cost
$196,928
Indirect Cost
Name
New England College of Optometry
Department
Type
Schools of Optometry/Ophthalmol
DUNS #
076614874
City
Boston
State
MA
Country
United States
Zip Code
02115
Liu, Lei; Marsh-Tootle, Wendy; Harb, Elise N et al. (2016) A sloped piecemeal Gaussian model for characterising foveal pit shape. Ophthalmic Physiol Opt 36:615-631
Scheiman, Mitchell; Gwiazda, Jane; Zhang, Qinghua et al. (2016) Longitudinal changes in corneal curvature and its relationship to axial length in the Correction of Myopia Evaluation Trial (COMET) cohort. J Optom 9:13-21
Manny, Ruth E; Deng, Li; Gwiazda, Jane et al. (2016) Internal Astigmatism in Myopes and Non-myopes: Compensation or Constant? Optom Vis Sci 93:1079-92
Harb, Elise; Hyman, Leslie; Gwiazda, Jane et al. (2015) Choroidal Thickness Profiles in Myopic Eyes of Young Adults in the Correction of Myopia Evaluation Trial Cohort. Am J Ophthalmol 160:62-71.e2
Scheiman, Mitchell; Zhang, Qinghua; Gwiazda, Jane et al. (2014) Visual activity and its association with myopia stabilisation. Ophthalmic Physiol Opt 34:353-61
Gwiazda, Jane; Deng, Li; Manny, Ruth et al. (2014) Seasonal variations in the progression of myopia in children enrolled in the correction of myopia evaluation trial. Invest Ophthalmol Vis Sci 55:752-8
Deng, Li; Gwiazda, Jane; Manny, Ruth E et al. (2014) Limited change in anisometropia and aniso-axial length over 13 years in myopic children enrolled in the Correction of Myopia Evaluation Trial. Invest Ophthalmol Vis Sci 55:2097-105
Dias, Lynette; Manny, Ruth E; Weissberg, Erik et al. (2013) Myopia, contact lens use and self-esteem. Ophthalmic Physiol Opt 33:573-80
COMET Group (2013) Myopia stabilization and associated factors among participants in the Correction of Myopia Evaluation Trial (COMET). Invest Ophthalmol Vis Sci 54:7871-84
Harb, Elise; Hyman, Leslie; Fazzari, Melissa et al. (2012) Factors associated with macular thickness in the COMET myopic cohort. Optom Vis Sci 89:620-31

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