Intrasurgical Optical Coherence Tomography

DESCRIPTION provided by applicant Each year over million ophthalmic surgeries are performed worldwide Indications for ophthalmic surgery include potentially blinding diseases such as cataracts diabetic retinopathy macular disease and retinal detachment Surgeons performing these delicate procedures are challenged by the translucent nature of tissues in the eye making it nearly impossible to visualize microstructural changes during surgery Optical coherence tomography OCT is a non contact optical imaging modality that provides high resolution cross sectional images of the various layers of the anterior and posterior eye OCT is also commonly used to aid in ophthalmic surgical planning and post operative assessment and more recently has been used perioperatively Intraoperative OCT offers the surgeon the ability to see the microstructure of the eye in a way not possible with conventional surgical microscopes By improving tissue visualization and providing surgical feedback intraoperative OCT will enhance surgical precision decrease surgical trauma aid in surgical decision making and ultimately improve functional and anatomical outcomes Bioptigen is at the forefront of intrasurgical OCT imaging technology with the only OCT system on the market with an FDA approved indication for intrasurgical imaging Currently intrasurgical imaging is performed using a hand held probe or by mounting such a probe to the surgical microscope In this proposal we describe the development of an intraoperative OCT system integrated directly into the optical train of the surgical microscope In Phase I we will complete development of the SMI and integrate it with our OCT engine technology We will also verify the optical performance of the SMI In Phase II Bioptigen will focus on the development of surgery specific software Initial testing and evaluation of the intraoperative OCT system will also be performed in Phase II in collaboration with the Cole Eye Institute at the Cleveland Clinic This initial testing will includ laboratory feasibility testing quality assessment and ergonomic evaluation Following initial testing our collaborators will perform simulated surgical procedures with intraoperative OCT Feedback from these initial tests and simulated surgeries will be used to iterate on system design in preparation for human clinical studies Ultimately the commercialization of intraoperative OCT technology will bring state of the art OCT imaging technology to the surgical bedside improving the quality of care for millions of patients each year PUBLIC HEALTH RELEVANCE What cannot be seen cannot be treated $ B is spent in the US alone on secondary procedures related to cataract operations The Cleveland Clinic has shown that in of retinal surgeries membranes are left behind or subsurface damage goes unnoticed Image guidance in the form of high resolution intrasurgical optical coherence tomography or andquot optical ultrasound andquot has dramatic potential to improve outcomes minimize surgical risks and shave billions of dollars off the cost of ophthalmic healthcare