Myopia Control in Children with Low-Dose Atropine and Soft Bifocal Contact Lenses

使用低剂量阿托品和软双焦点隐形眼镜控制儿童近视

• 批准号: 10083805
• 负责人: Juan Huang
• 金额: $ 15万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10083805
• 关键词: Myopia; Control; Children; Low; Dose

 DESCRIPTION (provided by applicant): The goals of this career development award are three-fold: 1) to provide training to Juan Huang, PhD OD to become an independent clinician-scientist; 2) to investigate whether adding 0.01% low concentrate atropine to soft bifocal contact lens wear will result in a greater effect of slowing myopia progression than administering soft bifocal contact lens alone in children; and 3) to evaluate the relationship between short-term changes in choroidal thickness and long-term regulation of myopia progression and ocular growth. A five-year career development plan is proposed, including formal coursework in clinical and translational science, as well as collaboration with accomplished mentors who are experts in specific areas related to the proposed research project. The proposed study is aligned with NEI's objective to "evaluate the efficacy of potential treatments, such as pharmacological approaches, special spectacles, and contact lenses, for slowing the progression of myopia." Both atropine and soft bifocal contact lenses have been shown to slow myopia progression, and both can cause changes in choroidal thickness. But the relationship between these mechanisms is unclear. The central hypothesis to be tested is that atropine and soft bifocal contact lenses each exert their anti-progression actions through a common pathway that involves the choroid. If this is correct, then adding atropine treatment to soft bifocal contact lens wear will lead to a more effective slowing of myopia progression than prescribing soft bifocal contact lenses alone due to the additive effects in the common pathway. To test the hypothesis, I propose a clinical study, which would be an ancillary study of a multi-center, randomized clinical trial, the Bifocal Lenses In Nearsighted Kids (BLINK) Study (U10EY023208) chaired by my primary mentor. The BLINK Study compares myopia progression between subjects who wear single vision contact lenses and those wearing soft bifocal contact lenses. I will enroll an additional 49 subjects that are age-matched with the participants who are wearing +2.50D add soft bifocal contact lenses in the BLINK Study. The subjects I enroll will wear +2.50D add soft bifocal contact lenses in combination with daily administration of one drop of 0.01% atropine in each eye for three years. The rates of myopia progression and axial elongation will be compared to the rates in participants who are receiving treatment with +2.50D add soft bifocal contact lenses alone in the BLINK Study. Two specific aims will be addressed: Aim 1: To test whether the combined treatment of 0.01% atropine and soft bifocal contact lens wear produces slower myopia progression and axial elongation compared to soft bifocal contact lenses alone over 3 years. Aim 2: To test whether early changes in choroidal thickness can be used as predictors of long-term myopia progression / axial elongation. The results of this study will have significant implications for future studies to develop and test new therapeutic regimes that optimize the effect of myopia control through combined pharmacological and optical interventions. The outcomes will also aid in understanding the potential role of short-term changes of choroidal thickness in long- term regulation of myopia progression and ocular growth.

 描述（由申请人提供）：该职业发展奖的目标有三个方面：1）为Juan Huang，PhD OD提供培训，使其成为独立的临床医生-科学家; 2）研究在软性双焦接触透镜配戴中添加0.01%低浓度阿托品是否比单独使用软性双焦接触透镜对儿童的近视进展有更大的减缓作用;评估脉络膜厚度的短期变化与近视进展和眼球生长的长期调节之间的关系。提出了一个五年的职业发展计划，包括临床和转化科学的正式课程，以及与完成导师谁是与拟议的研究项目相关的特定领域的专家合作。这项拟议的研究与NEI的目标一致，即“评估潜在治疗方法的有效性，如药理学方法，特殊眼镜和隐形眼镜，以减缓近视的进展。“阿托品和软性双焦点隐形眼镜都被证明可以减缓近视的进展，两者都可以引起脉络膜厚度的变化。但这些机制之间的关系尚不清楚。待检验的中心假设是阿托品和软性双焦点角膜接触镜均通过涉及脉络膜的共同途径发挥其抗进展作用。如果这是正确的，那么在软性双焦点接触透镜配戴中加入阿托品治疗将导致 由于共同途径中的累加效应，与单独处方软性双焦点隐形眼镜相比，更有效地减缓近视进展。为了验证这一假设，我提出了一项临床研究，这将是一项多中心、随机临床试验的辅助研究，即由我的主要导师主持的近视儿童双焦点镜片（BLINK）研究（U10 EY 023208）。BLINK研究比较了配戴单光角膜接触镜和配戴软性双焦点角膜接触镜的受试者之间的近视进展。我将额外入组49例受试者，这些受试者与BLINK研究中配戴+2.50 D add软性双焦点角膜接触镜的受试者年龄匹配。我入组的受试者将配戴+2.50D加性软性双焦点角膜接触镜，每只眼睛每天滴入一滴0.01%阿托品，持续3年。将近视进展率和眼轴延长率与BLINK研究中仅接受+2.50 D附加软性双焦点角膜接触镜治疗的受试者的近视进展率和眼轴延长率进行比较。将讨论两个具体目的：目的1：测试与单独配戴软性双焦点接触镜相比，0.01%阿托品和软性双焦点接触镜透镜配戴联合治疗3年是否会减缓近视进展和眼轴延长。目的2：测试脉络膜厚度的早期变化是否可以用作长期近视进展/眼轴延长的预测因子。这项研究的结果将对未来的研究具有重要意义，以开发和测试新的治疗方案，通过联合药理学和光学干预来优化近视控制的效果。这些结果还将有助于理解脉络膜厚度的短期变化在近视进展和眼生长的长期调节中的潜在作用。