Soft Bifocal Contact Lens Myopia Control - Clincal Center

软双焦点隐形眼镜近视控制 - 临床中心

• 批准号: 8609228
• 负责人: Donald O. Mutti
• 金额: $ 48.97万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8609228
• 关键词: 11 year old; Address; Adherence; Advertisements; Affect; Child; Childhood; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Clinical trial protocol document; Confidentiality; Contact Lenses; Controlled Study; Data; Data Collection; Data Coordinating Center; Databases; Dose; Electronic Mail; Eligibility Determination; Enrollment; Ensure; Eye; Family; Family Sizes; Friends; Glass; Goals; Grant; Growth; Home environment; Human; Human Resources; Lead; Length; Letters; Manuals; Masks; Measures; Myopia; Newspapers; Ohio; Optometry; Outcome Measure; Pamphlets; Pediatric Research; Peripheral; Policies; Principal Investigator; Procedures; Protocols documentation; Publications; Pupil; Quality Control; Quality of life; Radio; Randomized; Randomized Clinical Trials; Recording of previous events; Refractive Errors; Retinal; Risk Factors; Schools; Shapes; Signal Transduction; Site; Surveys; Testing; Training; United States; Universities; Vision; Visit; Visual; Visual Acuity; aged; animal data; college; cycloplegic; follow-up; human subject protection; interest; primary outcome; prospective; public health relevance; research clinical testing; response; screening; secondary outcome; social; standard of care; web site

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.

描述(由申请人提供)：这项建议是由俄亥俄州立大学验光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，旨在研究商业上可获得的软性双焦点隐形眼镜是否以及通过什么机制可以减缓近视儿童的眼睛生长。动物实验数据和大量但科学上有限的人类临床评估表明，改变周边散焦的隐形眼镜可能会减缓近视的进展。第一个目标是进行一项严格的前瞻性随机临床试验，以确定供应周边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减缓儿童近视的进展，作为增加功率的函数。第二个目的是评估周围性近视是否是眼睛生长的视觉信号，通过确定周围性近视视网膜离焦后的进展速度是否遵循剂量依赖的反应。最终目标是确定近视进展减缓的结构性相关性：眼睛生长的任何减缓是局部和外围的、中心凹的、全局的，还是局限于一个以上的眼象限。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……里面 在这项试验中，294名7至11岁的近视儿童将被随机分配佩戴软性双焦点隐形眼镜(Biofinity多焦点+1.50Add或+2.50Add；Cooper Vision，Fairfield， 或单视隐形眼镜(Biofinity；库珀视觉，纽约费尔菲尔德)。主要的结果衡量标准是三年内睫状肌麻痹等效球镜自动屈光度的变化。次要结果是中央和外周眼球长度。协变量包括配戴隐形眼镜时在距离和近距离的周边散焦量、不戴隐形眼镜的距离周边屈光不正、远距离的高对比度视力和低对比度视力、高对比度近视力、调节滞后、瞳孔大小、家庭屈光不正病史、近视风险因素调查、特定视力的生活质量以及隐形眼镜的配戴依从性。