SBIR-STTR Award

Each year, over 20 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 Statement:


Public Health Relevance:
What cannot be seen cannot be treated. $1B is spent in the US alone on secondary procedures related to cataract operations. The Cleveland Clinic has shown that in 30%-50% 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 "optical ultrasound," has dramatic potential to improve outcomes, minimize surgical risks, and shave billions of dollars off the cost of ophthalmic healthcare.

Project Terms:
Algorithms; Animals; Anterior; arm; Automobile Driving; base; Cataract; Cataract Extraction; Clinic; Clinical; Clinical Research; Collaborations; commercialization; Complement; Computer software; cost; Decision Making; design; Development; Diabetic Retinopathy; Disease; disorder of macula of retina; Electronics; Environment; ergonomics; Evaluation; evaluation/testing; Eye; FDA approved; Feedback; flexibility; Hand; Healthcare; Human; Image; Image Analysis; Imagery; imaging modality; Imaging technology; improved; Industry; innovation; Institutes; intraoperative imaging; Laboratories; Left; Marketing; Membrane; Microscope; Modeling; Nature; Operating Rooms; operation; Operative Surgical Procedures; optic imaging; Optical Coherence Tomography; Optics; Outcome; Patients; Performance; Phase; Postoperative Period; Preparation; Procedures; public health relevance; Quality of Care; research study; Resolution; Retinal; Retinal Detachment; Risk; Simulate; Speed (motion); Structure; Surgeon; System; Technology; Testing; Time; Tissues; tool; Training; Trauma; Ultrasonography; Visualization software; Vitrectomy

Each year, over 20 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 Statement:


Public Health Relevance:
What cannot be seen cannot be treated. $1B is spent in the US alone on secondary procedures related to cataract operations. The Cleveland Clinic has shown that in 30%-50% 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 "optical ultrasound," has dramatic potential to improve outcomes, minimize surgical risks, and shave billions of dollars off the cost of ophthalmic healthcare.

NIH Spending Category:
Bioengineering; Diagnostic Radiology; Eye Disease and Disorders of Vision

Project Terms:
Algorithms; Animals; Anterior; arm; Automobile Driving; base; Cataract; Cataract Extraction; Clinic; Clinical; Clinical Research; Collaborations; commercialization; Complement; Computer software; cost; Decision Making; design; Development; Diabetic Retinopathy; Disease; disorder of macula of retina; Electronics; Environment; ergonomics; Evaluation; evaluation/testing; Eye; FDA approved; Feedback; flexibility; Hand; Health; Healthcare; Human; Image; Image Analysis; image guided; Imagery; imaging modality; Imaging technology; improved; Industry; innovation; Institutes; intraoperative imaging; Laboratories; Left; Marketing; Membrane; Microscope; Modeling; Nature; Operating Rooms; operation; Operative Surgical Procedures; optic imaging; Optical Coherence Tomography; Optics; Outcome; Patients; Performance; Phase; Postoperative Period; Preparation; Procedures; Quality of Care; research study; Resolution; Retinal; Retinal Detachment; Risk; Speed (motion); Structure; Surgeon; System; Technology; Testing; Time; Tissues; tool; Training; Trauma; Ultrasonography; Visualization software; Vitrectomy