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.

我们最近表明，核黄素的光激活和机械僵硬 可以使用两次光子的760 nm感染飞秒激光光通过两个光子来实现角膜 非线性光学（NLO）过程。 NLO比现有的主要优势 技术是交叉链接仅发生在FS的两光子焦点量中 激光灯，提供对区域，深度和几何形状的精确控制 机械僵硬的角膜，可以轻松量身定制为患者的角膜 地形。我们已进一步申请了FS激光输送系统，并显示可能会有所不同 通过将聚焦镜头的数值孔径（Na）更改为两光子焦点量 大大扩大CXL区域的横向和轴向尺寸，至150μm角膜 厚度。这大加速了NLO过程，提供了更快的过程 与标准治疗相比。我们还确定使用再生 放大的FS激光脉冲，可以通过 总体功率<46.1兆瓦，低于ANSI热限，可激光暴露于眼睛。 此外，我们在活兔模型中显示了我们的NLO CXL设备可以交叉链接A 4 毫米直径的中央角膜区域在5分钟内，产生1-2个角膜扁平的折叠剂。 我们进一步开发了一种FS角膜上皮微加工方法来增强 化学物质通过上皮渗透而不产生上皮损伤或 该过程后，避免了标准方案的主要不利影响。与此 现在，新技术掌握了，我们准备开发一个临床原型，将允许 该设备的测试以治疗近视，近视，长老会的圆锥角膜和低度 和散光。