In vivo high-definition 3D corneal imaging

角膜是我们视觉系统的最外层窗口，容易受到各种感染和疾病的影响。 角膜疾病是视力缺陷和失明的主要原因之一，被认为是第二大原因。 这是发展中国家失明的主要原因。全世界有近500万双眼角膜盲患者， 据估计，全球有2300万人患有单侧角膜失明。以保守 据估计，角膜疾病影响了美国近30万人，富克斯的营养不良影响了 40岁以上的人占4%。鉴于角膜疾病的广泛流行和几乎不可能 进行活检，需要高清角膜成像来辅助临床诊断，评估 疾病和治疗。此外，角膜是全世界最常见的移植组织。 Gabor域光学相干显微镜（GDOCM）是一种高分辨率、无损伤的成像技术 它可以在3D环境下观察体内的微观结构。初步数据表明，GDOCM具有以下特点 与现有角膜成像技术（包括镜面和共焦显微镜）相比的主要优势：1） 视野增加10- 100倍-这将导致角膜组织的更准确定性，因为更大的 可以评估面积; 2）同时测量角膜厚度，定量内皮细胞密度， 以及识别由于角膜疾病引起的形态变化-这将导致全面的角膜评估 3）在半透明角膜细胞镶嵌的细胞水平上的3D成像能力-这 将能够详细了解疾病的体积进展。 我们已经组建了一个非常强大的临床研究团队来合作这项提案， 在他们的帮助下，我们已经确定了我们的双成像技术的临床应用的四个用例， 角膜的体积细胞分辨率。我们设想，在未来的双OCT（光学相干 断层扫描）和GDOCM仪器将提供图像引导 帮助临床医生评估和治疗角膜疾病和其他影响 眼睛的前部，包括糖尿病和青光眼。

The cornea, the outermost window of our visual system, is vulnerable to various types of infections and diseases. Corneal disease is one of the leading causes of visual deficiency and blindness, and is considered the second major cause of blindness in developing countries. There are nearly 5 million bilaterally corneal blind persons worldwide, and an estimated 23 million people affected by unilateral corneal blindness globally. In a conservative estimate, corneal diseases affect nearly 300,000 people in the United States, with Fuchs’ dystrophy affecting 4% of people aged over 40. Given the large prevalence of corneal disease and the near-impossibility of performing biopsy, high-definition corneal imaging is needed to assist clinical diagnosis, evaluate progression of diseases, and treatment. Additionally, the cornea is the most commonly transplanted tissue worldwide. Gabor-domain optical coherence microscopy (GDOCM) is a high-resolution, non-invasive imaging technology that can visualize microscopic structures in vivo in 3D. Preliminary data suggest that GDOCM has the following key advantages over existing corneal imaging techniques, which include specular and confocal microscopy: 1) 10-100x increase in field of view – this will lead to more accurate qualification of the corneal tissue, since a larger area can be assessed; 2) simultaneous measure of corneal thickness, quantification of endothelial cell density, as well as identification of morphological variations due to corneal disease – this will lead to full corneal evaluation in one instrument; 3) 3D imaging capability at the cellular level of the mosaic of translucent corneal cells – this will enable a detailed understanding the volumetric progression of the diseases. We have assembled an exceptionally strong team of clinical investigators to collaborate on this proposal, and with their help we have identified four use cases for clinical application of our dual-imaging technology to image the cornea with volumetric cellular-resolution. We envision that in the future the dual OCT (optical coherence tomography) and GDOCM instrument enabled by this Phase II SBIR proposal will provide an image-guidance method to assist clinicians in the assessment and treatment of corneal diseases and other diseases affecting the anterior segment of the eye, including diabetes and glaucoma.