Permanent Contact Lenses

描述（由申请人提供）：全球估计有23亿人患有屈光不正，如近视、远视和散光。虽然眼镜、传统隐形眼镜和激光手术矫正能够充分治疗大多数患病人群，但它们并非没有自己的并发症和问题。用生物集成永久接触透镜增强天然角膜将提供屈光矫正，其安全性和便利性水平是目前市售产品无法实现的。生物整合型永久性接触透镜的优点包括：1）通过快速手术植入，双眼可能不到20分钟，不需要去除任何基质组织2）可逆性和调节的可能性。接触透镜虽然被描述为“永久性的”，但如果需要，仍然可以通过将其从Bowman膜上剥离来移除和更换接触透镜，因此如果需要，允许在矫正中进行调整。3)更强的抗感染能力，因为接触透镜不需要频繁的手动操作，并且被上皮细胞覆盖，上皮细胞是人体的第一道免疫防御线。4)可能降低患者的成本。接触透镜可以使用寿命，并且不需要像LASIK的情况那样使用昂贵的激光。KeraMed Inc.已经开发了一种新颖的永久性接触透镜，其被设计为易于植入和生物相容。我们的目标是通过体外和体内动物实验来测试永久性角膜接触镜的生物相容性和保持力。如果我们的项目成功，我们将朝着改善人类视力和生活质量迈出重要一步。公共卫生意义：我们正在开发一种永久性接触透镜，可以安全快速地植入矫正屈光不正。这种“永久性”接触透镜也被设计为可移除的，并且在必要时可更换。

DESCRIPTION (provided by applicant): An estimated 2.3 billion people worldwide suffer from refractive errors such as myopia, hyperopia, and astigmatism. While glasses, traditional contact lenses, and laser surgical correction are capable of adequately treating a majority of the afflicted population, they are not without their own complications and problems. Augmentation of the natural cornea with a bio-integrated permanent contact lens would provide refractive correction with a level of safety and convenience unachievable by currently marketed products. Advantages of a bio-integrated permanent contact lens would include: 1) Implantation by a quick procedure, probably less than 20 minutes for both eyes, which does not require the removal of any stromal tissue 2) Potential for reversibility and adjustment. The contact lens although it is described as "permanent" can still be removed and replaced if necessary by peeling it away from Bowman's membrane, thus allowing adjustments in correction if necessary. 3) Greater resistance to infection because the contact lens does not require frequent manual manipulation and is covered by epithelium, the body's first line of immune defense. 4) Potentially lower cost for the patient. The contact lens could last a lifetime and does not require the use of expensive lasers as in the case of LASIK. KeraMed Inc. has developed a novel permanent contact lens which is designed to be easily implantable and bio-compatible. Our goal is to test the biocompatibility and retention of permanent contact lenses through both in vitro and vivo animal experiments. If our project is successful, we will have made a significant step towards improving human vision and quality of life. PUBLIC HEALTH SIGNFICANCE: We are developing a permanent contact lens which can be implanted safely and quickly for the correction of refractive errors. This "permanent" contact lens is also designed to be removable and replaceable if necessary.