SBIR-STTR Award

Macular edema(ME) is a common cause of significant visual loss in a wide variety of ocular condition, including age-related macular degeneration (AMD) and diabetic retinopathy (DR). The early detection and classification of ME is of special importance in DR, since the optimum treatment depends on position, type, and extension of the ME. Our long term goal is to develop a clinically useful tool to map macula thickness, to screen for clinically significant macular edema, and to provide high resolution images of retinal cross-sections at any arbitrary retinal locations. In the proposed technique, the rapid transverse imaging mode of the scanning laser ophthalmoscope (SLO) will be combined with high depth resolution and sectioning capability of the optical coherence tomography (OCT). This instrument will be able to image the retina in three dimensions, delineate ME boundaries, and quantify ME volume. During Phase l of this study, we will focus our effort on proof of feasibility. We will modify a breadboard system based on a Topographic Scanning System TopSS(Laser Diagnostic Technologies, Inc.) perform in vivo measurements on a few normal subjects and a few ME patients, develop 3-D image processing software, and identify potential problems and improvements for Phase II work

Macular edema (ME) is a common cause of significant visual loss in a wide variety of ocular conditions. The early detection and classification of ME is of special importance in diabetic retinopathy (DR), the leading cause of new cases of legal blindness among working age Americans. It is important to distinguish between different types of ME in DR, since the optimum treatment depends on position, type, and extension of the ME. Furthermore, the optimum treatment time is when visual acuity not yet significantly affected. Therefore, there is a need for an instrument that is capable of detecting and locating ME in its early stage and of quantifying its extension in three dimensions. The confocal scanning laser ophthalmoscope (CSLO) and optical coherence tomography (OCT) are both clinically usefully retinal imaging techniques developed in the last decade. But neither technique in its current state is an effective clinical tool in managing ME. The long-term goal of this study is to provide a new technique that combines the advantages of CSLO and OCT. During Phase I of this study, the rapid transverse scanning and imaging mode of the CSLO was successfully combined with the increased depth resolution and sectioning capability of OCT. An instrument capable of recording 3D data sets of the human macula was developed. Recording time of a 256x128x64 pixel data set is only 1.2 seconds. The function of the instrument was demonstrated in a feasibility test in normal subjects and patients with ME. Retinal thickness maps were successfully generated and the reproducibility determined. ME could be located and imaged in three dimensions. In Phase II of this study, sensitivity, reproducibility, imaging depth and robustness of the instrument will be further improved. Close to production version prototypes will be developed and constructed. Extensive normative and clinical studies will be performed to optimize the detection and management of ME associated with age related macular degeneration and DR.

Thesaurus Terms:
biomedical equipment development, diabetic retinopathy, diagnosis design /evaluation, early diagnosis, edema, eye disorder diagnosis, ophthalmoscopy, optical tomography, retina disorder, three dimensional imaging /topography confocal scanning microscopy, glaucoma, glaucoma test, mathematical model bioimaging /biomedical imaging, clinical research, human subject, patient oriented research, vision test