Wavefront guided customized soft contact lens for highly aberrated eyes

这个快速通道小企业研究项目的最终目标是提高人们的视力， 具有显著改变角膜形状的异常角膜状况，例如圆锥角膜和角膜 移植角膜形状异常的患者， 和更高阶的像差。即使采用最佳球柱校正， 未校正的残余高阶像差导致视觉质量的临床显著下降。 校正高阶像差一直是具有挑战性的，这是由于不能测量高度像差和不能测量高度像差。 以及制造具有不规则（非旋转对称）表面的接触透镜 profile.该研究项目旨在通过开发商业级， 大动态范围波前传感器，结合自由曲面加工技术制作波前波导 定制软性隐形眼镜在第一阶段，我们将展示自由曲面加工的可行性 本发明涉及一种产生不规则（非旋转对称）透镜表面轮廓的技术， 顺序像差（阶段1目标1），并通过以下方式最大限度地减少透镜在眼睛上的不可预测的平移和旋转 定制与角膜的不规则前表面匹配的透镜的后表面（阶段1 Aim 2）。在第二阶段，目标1，我们将开发一个商业级的大动态范围波前传感器， 具有用于波前分析和接触透镜设计的用户友好的软件。在第二阶段，目标2，我们将评估 通过最小化以下因素的不利影响来最大化波前引导透镜的视觉益处的方法 残余透镜移动对校正性能的影响。然后，在第二阶段，目标3，我们将比较视觉 这种定制的软性接触透镜（CustomEyes）的效果与那些设计适合的软性接触镜片的效果一致 圆锥角膜眼睛，但与传统的球柱镜，以确定临床可行性和真正的 波前引导定制软透镜在圆锥角膜患者中提供的视觉益处。

The ultimate goal of this Fast Track small business research project is to improve the vision of people who have abnormal corneal conditions that substantially alter the corneal shape such as keratoconus and corneal transplant. Patients with abnormal corneal shapes have substantially larger magnitudes of both lower-order and higher-order aberrations compared to normals. Even with optimal sphero-cylindrical correction, the uncorrected residual higher order aberrations cause a clinically significant degradation in visual quality. Correcting the higher order aberrations has been challenging due to both the inability to measure highly aberrated eyes and to manufacture a contact lens with an irregular (non-rotationally symmetrical) surface profile. This research project is designed to address these current barriers by developing a commercial grade, large dynamic range wavefront sensor, together with freeform machining technology to fabricate wavefrontguided customized soft contact lenses. In Phase 1, we will demonstrate the feasibility of freeform machining technology to create an irregular (non-rotationally symmetrical) lens surface profile capable of correcting higher order aberrations (Phase 1 Aim 1) and minimizing unpredictable translation and rotation of the lens on eye by customizing the back surface of the lens matched to the irregular anterior surface of the cornea (Phase 1 Aim 2). In Phase 2, Aim 1, we will develop a commercial-grade large dynamic range wavefront sensor equipped with user-friendly software for wavefront analysis and contact lens design. In Phase 2, Aim 2, we will evaluate methods to maximize the visual benefit with the wavefront-guided lens by minimizing the adverse impact of residual lens movement on correction performance. Then, in Phase 2, Aim 3, we will compare the visual outcomes with this customized soft contact lens (CustomEyes) to those with soft contact lenses designed to fit keratoconic eyes but with conventional sphero-cylindrical optics to determine the clinical feasibility and the true visual benefit provided by the wavefront guided customized soft lens in keratoconus patients.