Soft Bifocal Contact Lens Myopia Control - Clincal Center

描述（由申请人提供）：本提案为俄勒冈州立大学视光学院诊所网站进行软性双焦点隐形眼镜近视控制研究，这是一项随机临床试验，旨在解决市售软性双焦点隐形眼镜是否以及通过何种机制减缓近视儿童的眼睛生长。实验动物数据和大量但科学上有限的人类临床评估表明，改变外周离焦的隐形眼镜可能会减缓近视的进展。第一个目的是进行一项严格的前瞻性随机临床试验，以确定提供周围视网膜近视离焦的双焦点隐形眼镜是否以剂量依赖的方式作为添加功率的功能减缓儿童近视的进展。第二个目的是通过确定进展速度是否遵循对周围性近视视网膜离焦的剂量依赖性反应来评估周围性近视是否是眼睛生长的视觉信号。最终目的是确定任何近视进展减缓的结构相关性：任何眼睛生长减缓是局部和周围，中央凹，整体，还是局限于另一个眼象限。与第二个和第三个目标相关的分析将确定软性双焦点隐形眼镜如何影响眼睛的生长，并最终优化减缓儿童近视进展的视觉信号。在

DESCRIPTION (provided by applicant): This proposal is for The OSU College of Optometry Clinic Site to conduct the Soft Bifocal Contact Lens Myopia Control Study, a randomized clinical trial designed to address whether and by what mechanism commercially available soft bifocal contact lenses may slow eye growth in myopic children. Experimental animal data and numerous but scientifically limited human clinical evaluations suggest that contact lenses that alter peripheral defocus may slow the progression of myopia. The first aim is to conduct a rigorous prospective randomized clinical trial 'to determine if bifocal contact lenses that supply peripheral retinal myopic defocus slow myopia progression in children in a dose-dependent manner as a function of add power. The second aim is to evaluate whether peripheral myopia is a visual signal for eye growth by determining whether the rate of progression follows a dose-dependent response to peripheral myopic retinal defocus. The final aim is to determine the structural correlates of any slowing of myopia progression: is any slowing of eye growth local and peripheral, foveal, global, or confined to one more ocular quadrants. Analyses related to the second and third aims will determine how soft bifocal contact lenses affect growth of the eye and, ultimately, to optimization of the visual signals that slow myopia progression in children. In this trial, 294 children aged 7 to 11 years with myopia will be randomly assigned to wear soft bifocal contact lenses (Biofinity Multifocal with +1.50 add or +2.50 add; Cooper Vision, Fairfield, NY) or single vision contact lenses (Biofinity; Cooper Vision, Fairfield, NY). The primary outcome measure is change in cycloplegic spherical equivalent auto refraction over three years. Secondary outcomes are central and peripheral eye length. Covariates include the amount of peripheral defocus at distance and near while wearing a contact lens, distance peripheral refractive error without a contact lens, high and low contrast visual acuity at distance, high contrast near visual acuity, accommodative lag, pupil size, family refractive error history, a myopia risk factor survey, vision-specific quality of life, and contact lens wear compliance.