Spectacle Prescribing in Early Childhood (SPEC)

幼儿期眼镜处方 (SPEC)

• 批准号: 10176507
• 负责人: Erin M Harvey
• 金额: $ 88.04万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10176507
• 关键词: 1 year old; 3 year old; Academy; Address; Advisory Committees; African American; Age; Age-Months; Amblyopia; American; Asians; Astigmatism; Cataract; Child; Childhood; Clinical; Clinical Trials; Consensus; Data; Detection; Development; Device or Instrument Development; Early treatment; Equilibrium; Ethnic group; Evidence based treatment; Eye; Eye diseases; Eyeglasses; Guidelines; Hispanics; Home; Hyperopia; Infant; Literature; Measures; Medical; Native Americans; Ophthalmology; Outcome; Outcome Measure; Parents; Performance; Population Study; Preventive service; Protocols documentation; Public Health; Publishing; Recommendation; Refractive Errors; Risk Factors; School-Age Population; Strabismus; Toddler; Tribes; United States; Vision; Vision Screening; Visual; Visual Acuity; age group; base; care providers; clinical care; compliance behavior; early childhood; evidence base; evidence based guidelines; experience; improved; instrument; meetings; member; multi-ethnic; pediatrician; prospective; racial and ethnic; screening; screening guidelines; technology validation; vision development; wearable device; wearable sensor technology

PROJECT SUMMARY The benefits of early spectacle treatment for moderate refractive error in asymptomatic toddlers are not known. AAPOS spectacle prescribing guidelines for children less than 3 years of age are based on consensus and clinical experience because “there are no scientifically rigorous published data for guidance”. The United States Preventive Services Task Force concluded in 2017 that there is insufficient evidence to assess the balance of benefits of vision screening for children less than 3 years of age because data on the benefits of spectacle correction for refractive error in toddlers are lacking. The SPEC Trial addresses these important gaps in the literature with a focus on assessing the developmental and visual benefits of spectacle treatment for astigmatism in toddlers, and the factors associated with spectacle treatment compliance in this age group. SPEC is a prospective trial to determine if prescribing and providing spectacle correction for astigmatic toddlers (at 12 to < 24 months or 24 to < 36 months of age) meeting current consensus based prescribing guidelines result in better developmental and visual outcome compared to astigmatic children who are prescribed and provided spectacles at age 36 to < 40 months. Developmental outcomes will be measured using the Bayley Scales of Infant and Toddler Development, 3rd Edition. Visual acuity outcome will be measured using the Amblyopia Treatment Study HOTV Protocol. Spectacle treatment compliance will be measured using a wearable sensor attached to the spectacles. The results of the SPEC Trial will have important implications for screening and treatment of young astigmatic children. This study will generate evidence to inform parents, pediatricians, and eye care providers if prescribing spectacles for astigmatic toddlers will have a beneficial effect on their global development, and will allow clinicians to make evidence-based, rather than consensus-based, recommendations regarding treatment of astigmatism in toddlers. The SPEC Trial is also unique in that it includes objective measures of spectacle treatment compliance, and will provide much needed data on factors associated with spectacle treatment compliance in toddlers.

项目摘要 早期眼镜治疗无症状幼儿中度屈光不正的益处 不知道。3岁以下儿童的AAPOS眼镜处方指南 是基于共识和临床经验，因为“没有科学严谨的 发布的指导数据”。美国预防服务工作队在2005年得出结论， 2017年，没有足够的证据来评估视力筛查的益处， 3岁以下的儿童，因为关于眼镜矫正的益处的数据， 屈光不正的幼儿缺乏。SPEC试验解决了 重点评估眼镜的发育和视觉益处的文献 幼儿散光的治疗，以及与眼镜治疗相关的因素 在这个年龄段的配合。 SPEC是一项前瞻性试验，旨在确定是否处方和提供眼镜矫正， 符合当前标准的蹒跚学步儿童（12至< 24个月或24至< 36个月） 基于共识的处方指南导致更好的发育和视力结果 与在36岁至< 40岁时处方并提供眼镜的近视儿童相比， 个月将使用贝利婴儿量表测量发育结局， 幼儿发展，第三版。将使用弱视量表测量视力结局 治疗研究HOTV方案。将使用一个 可穿戴传感器附在眼镜上。 SPEC试验的结果将对筛查和治疗 年幼的孩子。这项研究将提供证据，告知父母，儿科医生， 和眼科护理提供者，如果处方眼镜的蹒跚学步的孩子将有一个有益的 影响其全球发展，并将使临床医生以证据为基础， 而不是基于共识的关于幼儿散光治疗的建议。的 SPEC试验的独特之处还在于它包括眼镜治疗的客观措施 合规性，并将提供与眼镜治疗相关的因素急需的数据 幼儿的依从性。