SBIR-STTR Award

Dry Eye disease is an affliction that impacts as many much as 20% of the U.S. population over age 50, and is even more prevalent in the Asia Pacific. Dry eye therapies are currently a $1.7B market, growing at 10% annually. Treatment is primary palliative, involving warm compresses and eye drops. TearScience recently released LipiFlow to thermally improve meibomian gland function. Corneal dystrophies include disease and injury of the epithelium, stroma and endothelium. 2.5M Americans suffer from eye injury each year. There are 80,000 corneal transplants and grafts annually. Keratoconus affects 1 in 2000. 35M Americans wear contact lenses and approximately 3M Americans undergo some sort of refractive surgery each year. The contact lens industry is $3B retail industry, and investment in surgical procedures and devices for management of disease and for refractive correction continues to be strong. Yet with the prevalence of these outer anterior disease states, the capabilities of spectral domain optical coherence tomography have yet to define a role. The objective of this proposal is to develop an imaging handpiece that is more suited to clinically useful imaging of the cornea, the tear film, and the tissue ultrastructure of the inner eyelid, conjunctiva and sclera. The notable design objective is to provide optics suited to imaging curved surfaces with a wide field of view. In accomplishing this objective, there are three separable technical challenges: 1. Invert the scanned focal field to match the surface of the cornea; 2. Equalize the optical path lengths so that a spherical surface is imaged to a plane at constant image depth; 3. Introduce optical elements that allow such a design to be compact and cost effective. The anticipated outcome of the Phase I activities is a working prototype of an anterior segment scanner uniquely suited to imaging the outer anterior segment structures which will have been verified through bench testing and validated through small animal imaging. This work will pave the way to product development and commercialization of the outer anterior segment probe. That product will provide a new diagnostic tool to support the evaluation and treatment of glandular and muscular dysfunctions and dry eye disease. Additionally, the product will improve imaging of the cornea surface with significant potential to aid in the diagnosis and treatment of corneal dystrophies, keratoconus and wound healing with true limbus-to-limbus capabilities. Further, this product will offer a new view to the irido-corneal angle for assessment of narrow angle glaucoma.

Public Health Relevance:
Dry Eye disease is an affliction that impacts as many much as 20% of the U.S. population over age 50, 2.5M Americans suffer from eye injury each year, 35M Americans wear contact lenses, and approximately 3M Americans undergo some sort of refractive surgery each year. Spectral Domain Optical Coherence Tomography (SDOCT) is a technology that is used for imaging the eye to aid in diagnosis of some diseases of the eye, but it has yet to be tailored specifically to imaging the tear film, cornea, and other structures in th front of the eye that are associated with dry eye and refractive errors. Bioptigen is proposing the development of a new scanner for SDOCT systems that will enable high quality imaging of these structures and could greatly aid in research on these structures of the eye and in the diagnosis of diseases and treatment of injuries of the front of the eye.

Public Health Relevance Statement:
Dry Eye disease is an affliction that impacts as many much as 20% of the U.S. population over age 50, 2.5M Americans suffer from eye injury each year, 35M Americans wear contact lenses, and approximately 3M Americans undergo some sort of refractive surgery each year. Spectral Domain Optical Coherence Tomography (SDOCT) is a technology that is used for imaging the eye to aid in diagnosis of some diseases of the eye, but it has yet to be tailored specifically to imaging the tear film, cornea, and other structures in th front of the eye that are associated with dry eye and refractive errors. Bioptigen is proposing the development of a new scanner for SDOCT systems that will enable high quality imaging of these structures and could greatly aid in research on these structures of the eye and in the diagnosis of diseases and treatment of injuries of the front of the eye.

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

Project Terms:
Affect; Age; Am 80; American; Angle-Closure Glaucoma; Animals; Anterior; Arts; Asia; base; Canis familiaris; commercialization; conjunctiva; Contact Lenses; Cornea; Corneal dystrophy; cost effective; design; Development; Devices; Diagnosis; Diagnostic; Disease; disease diagnosis; Disease Management; Elements; Endothelium; Epithelium; Evaluation; Eye; Eye diseases; eye dryness; Eye Injuries; Eyedrops; Eyelid structure; Film; Functional disorder; Government; Housing; Image; improved; Industry; Injury; Investments; Keratoconus; Keratoplasty; Length; Marble; Marketing; Mechanics; meibomian gland; Meniscus structure of joint; Molds; Muscle; novel diagnostics; Operative Surgical Procedures; optic imaging; Optical Coherence Tomography; Optics; Oryctolagus cuniculus; Outcome; palliative; Pathology; Performance; performance tests; Persons; Phase; Population; Prevalence; product development; prototype; Refractive Errors; Research; Role; Scanning; Sclera; Small Business Innovation Research Grant; Sorting - Cell Movement; Specific qualifier value; Structure; Surface; System; Technology; Testing; Time; Tissues; tool; Work; Wound Healing