Optical aberration and visual performance in highly aberrated eyes

描述(申请人提供)：最近基于实验室的研究集成了眼部波前传感和眼科镜片车削的进步，证明了定制的波前引导软性隐形眼镜可以为高度像差的眼睛设计和制造。这些镜片提供了更好的舒适性、视网膜图像质量和视觉效果，而不是常规的高度像差眼睛的硬性镜片矫正。不幸的是，目前向患者提供这种镜片所需的过程既耗时又复杂，在临床上是可行的，也不符合成本效益。要以安全和高效的方式将这项实验室工作转化为临床实践，需要：1)开发有效的方法来预测控制镜片移动；2)开发有效的设计流程，根据所需的镜片移动和所需的光学和视觉性能水平智能地实施个人光学矫正；以及3)研究这些定制镜片的纵向有效性和安全性。这项为期5年的赠款的具体目标如下所示，并将在高度屈光不正的样本人群中直接解决这些问题。将检验以下假设：1.由角膜曲线匹配和传统稳定方法组成的多分量稳定技术可以用于预测和有效地将定制波前引导的软性隐形眼镜的光学区与高度像差的眼睛的光学部分对准。2.可以开发一种时间和成本高效的智能设计过程，将测量的透镜移动、期望的视网膜图像质量和期望的视觉性能定量地集成到定制透镜的设计中。3.当以日常佩戴的方式佩戴时，波前引导的软透镜矫正在光学质量、视觉性能、舒适性和佩戴时间方面提供了持续的改善，并显著提高了生活质量。这里提出的工作对NIH/NEI的使命至关重要，因为当成功完成后，它将把实验室研究转化为临床护理，减少视力损害并提高高度屈光眼患者的生活质量。与公共卫生相关：在多个独立的研究实验室环境中，已经在小范围内证明了定制波前引导的软性隐形眼镜可以补偿个人高度像差眼睛的低阶像差(球面、柱面)和高阶像差(彗差、三叶形、球面像差等)。这些早期的工作表明，定制软性隐形眼镜可以设计成达到或超过目前黄金标准硬性矫正形式的性能。然而，软性隐形眼镜技术的这些进步是以设计和制造过程中的高度复杂性为代价的，使得目前形式的定制隐形眼镜不可能在临床上大规模部署。这就提出了一个问题：为了让定制波前引导的软性隐形眼镜获得临床实用价值，必须克服哪些障碍？这些障碍可以概括为三个字：稳定、优化和示范。这笔赠款的具体目的将是：1)开发方法，使定制软性隐形眼镜能够在眼睛上实现可预测的稳定；2)研究方法，允许有效和智能地优化定制隐形眼镜治疗，以减轻视觉上削弱水平的光学像差的影响；3)展示定制软性隐形眼镜在日常佩戴模式下的功效。对这些问题的检查将产生必要的知识和工具，以便在当前的临床文化中利用这一有前途的新技术。据推测，这些目标的成功完成将导致能够在光学性能、视觉性能、舒适性和生活质量方面实现可量化改善的方法，这些个人由于疾病、创伤或先前的手术干预而患上高度屈光不正的眼睛。1

DESCRIPTION (provided by applicant): Recent laboratory-based research integrating advances in ocular wavefront sensing and ophthalmic lens lathing has demonstrated that custom wavefront-guided soft contact lenses can be designed and manufactured for the highly aberrated eye. These lenses provide improved comfort, retinal image quality and visual performance over rigid lens corrections routinely prescribed for the highly aberrated eye. Unfortunately the processes required to provide such a lens to the patient are currently time consuming and too complex to be clinically viable or cost effective. To translate this laboratory work into clinical practice in a safe and efficient manner requires: 1) development of efficient methods to predictably control lens movement; 2) development of an efficient design process to intelligently implement individual optical corrections based on required lens movement and desired optical and visual performance levels; and 3) studies examining longitudinal efficacy and safety of these custom lenses. The specific aims of this 5 year grant are listed below and will directly address these issues in a sample population of highly aberrated eyes. The following hypotheses will be tested: 1. A multi-component stabilization technique comprised of corneal curve matching and traditional stabilization methods can be used to predictably and efficiently align the optical zone of a custom wavefront-guided soft contact lens to the optics of the highly aberrated eye. 2. A time and cost efficient, intelligent design process can be developed that quantitatively integrates measured lens movement, desired retinal image quality and desired visual performance into the design of a custom lens. 3. When worn in a daily wear manner, wavefront guided soft lens corrections provide a sustained improvement in optical quality, visual performance, comfort and wear time with a quantifiable increase in quality of life. The work proposed here is central to the mission of the NIH/NEI in that when successfully completed, it will translate laboratory research into clinical care that reduces visual impairment and improves the quality of life of individuals with highly aberrated eyes. PUBLIC HEALTH RELEVANCE: Custom wavefront guided soft contact lenses that compensate for both low order aberrations (sphere, cylinder) and high order aberrations (coma, trefoil, spherical aberration, etc) of the individual highly aberrated eye have been demonstrated on a small scale within multiple independent research laboratory settings. These early works show that custom soft contact lenses can be designed to meet or exceed the performance of current gold standard rigid forms of correction. However, these advances in soft lens technology come at the price of significant complexity in the design and manufacture process, making large-scale clinical deployment of custom contact lenses in their current form impossible. This raises the question: what obstacles must be overcome in order for custom wavefront guided soft contact lenses to attain clinical relevance? These obstacles can be summarized in three words: stabilization, optimization and demonstration. The specific aims in this grant will: 1) develop methods to allow for predictable stabilization of a custom soft contact lens on the eye; 2) examine methods that allow for the efficient and intelligent optimization of customized contact lens treatments that mitigate the effects of visually debilitating levels of optical aberration and 3) demonstration of the efficacy of custom soft contact lenses in a daily wear modality. Examination of these issues will result in the knowledge and tools necessary to capitalize on this promising new technology in the current clinical culture. It is hypothesized that successful completion of these aims will lead to methods allowing quantifiable improvements in optical performance, visual performance, comfort and quality of life for the individual that, due to disease, trauma or prior surgical intervention, suffers from highly aberrated optics of the eye. 1