The exponential increase of diabetics and the elderly in the U.S. has at least tripled cataract surgeries in just two decades. As many as half of these surgeries will lead to posterior capsular opacification (PCO), which requires follow-up surgery using Nd:YAG laser capsulotomy. Without this additional surgery, patients can suffer permanent vision loss. In many countries laser capsulotomy is not available, and PCO results in blindness. PCO is the number one complication of cataract surgery, and has resulted in >$250 million in annual costs for the U.S. Medicare system alone. Costs will exceed $1 billion by 2050. PCO adds patient care and cost burden beyond the cataract surgery itself. The number of diagnosed diabetics in the U.S. has far out-paced predictions, and this group experiences high rates of cataract formation, with more-difficult recovery from surgery. As the aging population requires more of these surgeries and diabetes becomes an epidemic, costs will escalate significantly. Clearly, PCO procedures are a significant patient care problem and are escalating healthcare costs. PCO is not even an option in many parts of the world, where patients experience vision loss due to lack of resources. It is thus important to eliminate the need for PCO. Ideally, no follow-up surgery would be required after the initial cataract removal. PCO results from attachment/migration of lens epithelial cells (LECs) behind the intraocular lens (IOL). These cells cause the opacification of the posterior lens capsule that impairs vision and requires follow up laser therapy. An IOL that eliminates PCO would eliminate the need for laser capsulotomy-greatly reducing associated risks and costs. The ideal device would not use potentially harmful pharmacologic agents that can result in inflammation or other complications. Sharklet Technologies Inc. proposes to develop a new device designed to inhibit LEC attachment/migration behind the IOL, and to team with industry to market the device in the U.S. and worldwide. The device is a Sharklet-patterned membrane (PM) integrated onto an IOL. Made of the same material as the IOL, the PM provides two critical support elements: a square edge that prevents equatorial LECs from migrating along the posterior surface of the capsular bag, and the Sharklet pattern that further inhibits attachment and migration of LECs from the periphery of the capsular bag into the visual axis. The overall project goal is to validate, prototype, and pre-manufacture the PM/IOL integrated device, with validation of the PM concept in Phase I and integration of the PM/IOL during Phase II. Phase I goals are to 1) establish proof-of-concept that the Sharklet pattern reduces the mechanisms of LEC attachment and migration via in vitro testing with LECs, and 2) validate that the PM reduces PCO in vivo in rabbit eyes. Sharklet's preliminary data and expert, multi-disciplinary team sets the stage for a successful Phase I proof-of- concept project designed to lead to Phase II work focused on PM/IOL integrated prototype suitable for pre- manufacturing studies and testing in a statistically powered animal study prior to clinical studies in Phase III.

Public Health Relevance

A serious complication of cataract surgery, called secondary cataract, occurs in 25% to 50% of cataract surgeries, requiring follow-up laser surgery that represents an additional risk to patients and over $300 million in added medical costs per year in the U.S alone. Sharklet Technologies, Inc. proposes to develop a novel micro-patterned membrane designed to be integrated into a next-generation intraocular lens that has added functionality to prevent secondary cataract formation. Based on the success of this multi-phase SBIR project, the novel device we envision is expected to have a significant impact on improving patient care worldwide and reducing healthcare costs, which are rising steadily in the U.S. due to growing patient populations with increased cataract susceptibility.

National Institute of Health (NIH)
National Eye Institute (NEI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Wujek, Jerome R
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Sharklet Technologies, Inc.
United States
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Kramer, Gregory D; Werner, Liliana; MacLean, Kyle et al. (2015) Evaluation of stability and capsular bag opacification with a foldable intraocular lens coupled with a protective membrane in the rabbit model. J Cataract Refract Surg 41:1738-44