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Sponsors and Collaborators: |
Ohio State University National Eye Institute (NEI) |
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Information provided by: | Ohio State University |
ClinicalTrials.gov Identifier: | NCT00335049 |
At this time, we do not know what causes a child to become more nearsighted (myopic). STAMP will help us better understand nearsightedness in children.
Children will be randomly chosen to wear regular glasses (single vision lenses) or no-line bifocal glasses (progressive addition lenses) for the first year of the study. All children will wear regular glasses for the second year of the study. STAMP will compare how the eye changes shape in the two groups to help us understand why children become nearsighted. The two theories of myopia progression that are being evaluated are based on different factors. One theory is based on environmental factors such as extended near work while the other theory is based on genetically coded factors.
Condition | Intervention |
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Myopia |
Device: progressive addition spectacle lens (bifocal) Device: Single Vision Lenses (SVLs) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Study of Theories About Myopia Progression (STAMP) |
Estimated Enrollment: | 84 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PAL: Experimental
Progressive Addition Spectacle Lenses (PALs) with a +2.00 D add worn for first year off study. Single Vision Lenses worn for second year of study.
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Device: progressive addition spectacle lens (bifocal)
Progressive addition lenses (PAL) with a +2.00 D add.
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SVL: Placebo Comparator
Single Vision Lenses (SVLs) worn both years of the study.
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Device: Single Vision Lenses (SVLs)
Single vision spectacle lenses.
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Eligible children will be enrolled, randomized, and followed at six-month intervals for two years with all children wearing single vision lenses for the second year. At each visit, complete measurements of the components of the eye will be made to explain the mechanism responsible for the Progressive Addition Lens (PAL) treatment effect and why it occurs mainly during the first year of bifocal wear (Gwiazda et al. 2003). While hyperopic retinal blur (blur at the back of the eye) due to accommodative lag (poor focusing when doing close work) has been proposed as a possible mechanism driving myopia progression (Gwiazda et al. 1993), others have shown that accommodative lag accompanies rather than precedes the onset of myopia (Mutti et al., 2006).
This suggests that accommodative lag is a result of another possible mechanism resulting in myopia progression such as crystalline lens-induced ciliary-choroidal tension (a model in which the lens in the eye is stretched and is not as good at focusing up close) (Mutti et al., 2000). According to this proposed mechanism, high accommodative lag in myopia results from increased crystalline lens tension that is transmitted through the choroid (an outside layer of the eye). This tension results in restricted equatorial (the vertical dimension of the eye) eye growth with no axial (front to back) restriction to eye growth and yields a prolate ocular shape (an eye that is longer than it is wide) in myopes (Mutti et al., 2000).
Comparisons: Refractive error (glasses prescription), axial length (length of the eye), peripheral eye shape, accommodation (focusing ability), corneal shape (shape of the front of the eye), anterior chamber depth, crystalline lens thickness and curvatures (shape of the lens in the eye), central and peripheral higher-order aberrations (how well light focuses in the eye), and phoria (eye alignment) will be measured at six-month intervals. The primary study outcome is refractive error measured by cycloplegic autorefraction. Comparison of the biometric data collected both during the first year when the PAL intervention is present and during the second year when the PAL intervention is removed will allow us to differentiate between the two theories under consideration. We will also evaluate whether the modest PAL treatment effect that has been reported during the first year of PAL wear is permanent.
Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(The criteria below will be evaluated at a screening visit to find out if the child can participate)
Exclusion Criteria:
United States, Ohio | |
The Ohio State University College of Optometry | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | David A Berntsen, OD, MS | Ohio State University |
Principal Investigator: | Karla Zadnik, OD, PhD | Ohio State University |
Principal Investigator: | Donald O Mutti, OD, PhD | Ohio State University |
Responsible Party: | The Ohio State University ( Karla Zadnik, OD PhD / Principal Investigator ) |
Study ID Numbers: | 2005H0157, K12-EY015447 |
Study First Received: | June 7, 2006 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00335049 History of Changes |
Health Authority: | United States: Institutional Review Board |
myopia progression bifocal |
Eye Diseases Disease Progression Myopia Refractive Errors |
Disease Attributes Pathologic Processes Eye Diseases |
Disease Progression Myopia Refractive Errors |