Myopia control in children with low-dose atropine and soft bifocal contact lenses

 描述(由申请者提供)：这个职业发展奖的目标有三个：1)为Juan Huang提供培训，使其成为一名独立的临床科学家；2)研究在配戴软双焦点隐形眼镜时添加0.01%低浓度阿托品是否比单戴软双焦点隐形眼镜更能有效地减缓儿童的近视进展；以及3)评估脉络膜厚度的短期变化与长期调节近视进展和眼睛生长的关系。提出了一项为期五年的职业发展计划，包括临床和转化科学方面的正式课程，以及与与拟议研究项目相关的特定领域的专家、经验丰富的导师的合作。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进展，而且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。需要检验的中心假设是阿托品和软性双焦点隐形眼镜各自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，那么在软性双焦点隐形眼镜配戴中加入阿托品治疗将导致 由于共同路径中的相加效应，比单独使用软性双焦点隐形眼镜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，由我的主要导师主持的双焦点透镜在近视儿童(BLINK)研究(U10EY023208)。这项眨眼研究比较了戴单眼隐形眼镜和戴软性双焦点隐形眼镜的受试者的近视进展。我将另外招募49名年龄与BLINK研究中戴+2.50D ADD软性双焦隐形眼镜的参与者匹配的受试者。我登记的受试者将配戴+2.50D的软性双焦点隐形眼镜，并每天每只眼睛滴一滴0.01%阿托品，为期三年。在BLINK研究中，近视进展率和眼轴延长率将与仅接受+2.50D附加软性双焦点隐形眼镜治疗的参与者的近视进展率和眼轴延长率进行比较。目标1：测试戴0.01%阿托品和戴软性双焦点隐形眼镜的联合治疗是否比单独佩戴软性双焦点隐形眼镜在3年内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作为预测远期近视进展/眼轴延长的指标。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，通过联合药物和光学干预来优化近视控制的效果。这些结果也将有助于理解脉络膜厚度的短期变化在近视进展和眼睛生长的长期调节中的潜在作用。

 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.