Non-Linear Optical femtosecond laser device to alter corneal curvature and stiffness.

非线性光学飞秒激光装置可改变角膜曲率和硬度。

• 批准号: 10392214
• 负责人: Michael Karavitis
• 金额: $ 25.57万
• 依托单位: M2-COR, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10392214
• 关键词: Address; Adverse effects; Affect; American; Amplifiers; Area; Astigmatism; Caliber; Chemicals; Clinical; Clinical Research; Collagen; Contact Lenses; Cornea; Corneal Topography; Devices; Dimensions; Disease; Disease Progression; Epithelial; Exposure to; Eye; Fiber; Frequencies; Funding; Generations; Geometry; Goals; Hand; Hyperopia; Implant; Individual; Infection; Keratoconus; Keratoplasty; Laser In Situ Keratomileusis; Lasers; Lateral; Legal patent; Light; Mechanics; Methods; Modeling; Myopia; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Pathological Dilatation; Patients; Penetration; Persons; Phase; Physiologic pulse; Postoperative Pain; Presbyopia; Procedures; Process; Protocols documentation; Recovery; Refractive Errors; Research; Riboflavin; Risk; Safety; Small Business Innovation Research Grant; Speed; Surgeon; System; Technology; Testing; Thick; Thinness; Transplantation Surgery; Ultraviolet Rays; United States; Vision; Visual; base; commercialization; corneal epithelium; cost; crosslink; design; free radical oxygen; instrument; lens; new technology; photoactivation; prototype; regenerative; standard care; two-photon

We have recently shown that photo-activation of riboflavin and mechanical stiffening of the cornea can be achieved using 760 nm infrared Femtosecond laser light through a two photon, nonlinear optical (NLO) process. The primary advantage of NLO over the existing technology is that cross linking occurs only within the two-photon focal volume of the FS laser light, providing precise control over the area, depth and geometry of the mechanically stiffened cornea that can be easily tailored to the patient's corneal topography. We have further patented an FS laser delivery system and shown that can vary the two-photon focal volume by changing the numerical aperture (NA) of the focusing lens to greatly expand the lateral and axial dimensions of the CXL region up to 150 μm of the corneal thickness. This greatly speeds up the NLO process, providing a more rapid procedure compared to that of standard treatments. We have also established that using regeneratively amplified FS laser pulses, mechanical stiffening of rabbit corneas can be achieved with an overall power of <46.1 mW, below the ANSI thermal limits for laser exposure to the eye. Additionally, we have shown in a live rabbit model that our NLO CXL device can crosslink a 4 mm diameter central corneal region in 5 minutes and produce 1-2 diopters of corneal flattening. We have further developed an FS corneal epithelial micromachining method to enhance penetration of chemicals through the epithelium without producing epithelial damage before or after the procedure, thus avoiding the major adverse effects of standard protocols. With this novel technology now in hand, we are ready to develop a clinical prototype that will allow for the testing of this device to treat keratoconus and low degrees of myopia, hyperopia, presbyopia and astigmatism.

我们最近发现核黄素的光活化和机械硬化 使用 760 nm 红外飞秒激光通过双光子可以实现角膜， 非线性光学（NLO）过程 NLO 相对于现有技术的主要优点。 技术的特点是交联仅发生在 FS 的双光子焦体积内 激光，提供对面积、深度和几何形状的精确控制 机械硬化的角膜，可以轻松地根据患者的角膜进行定制 我们还获得了 FS 激光传输系统的专利，并证明其可以变化。 通过改变聚焦透镜的数值孔径（NA）来获得双光子焦体积 极大地将 CXL 区域的横向和轴向尺寸扩展至角膜的 150 μm 这大大加快了 NLO 过程，提供了更快速的过程。 与标准治疗相比，我们还确定了使用再生疗法。 放大的 FS 激光脉冲，可以通过 总功率<46.1 mW，低于激光照射眼睛的 ANSI 热限值。 此外，我们在活体兔子模型中展示了我们的 NLO CXL 设备可以交联 4 毫米直径的角膜中央区域在5分钟内产生1-2屈光度的角膜变平。 我们进一步开发了 FS 角膜上皮微加工方法来增强 化学物质穿透上皮而不在之前或之前产生上皮损伤 程序后，从而避免了标准协议的主要不利影响。 现在掌握了新技术，我们已准备好开发一个临床原型，该原型将允许 测试该装置治疗圆锥角膜和低度近视、远视、老花眼 和散光。