I-Corps: Low-cost, handheld, manual cataract surgery device

The broader impact/commercial potential of this I-Corps project lies in its potential to address the leading cause of avoidable blindness. A total of 253 million people suffer from blindness or visual impairment, and 89% live in low- and middle-income countries (LMICs). Cataract surgery has been shown to improve physical and mental health, income, productivity, and quality of life, but it remains the leading cause of blindness globally.

The limitations of phacoemulsification have prevented broad implementation across emerging markets, causing disadvantaged patients and those with mature cataracts to receive manual small incision cataract surgery (MSICS). MSICS involves removal of the whole, intact cataract through a large incision. This 6-7 mm incision leads to increased recovery time and astigmatism.

Issues with affordability and acceptability of treatment delays care-seeking behavior, causing development of mature cataracts, and sometimes leading to blindness and significant functional limitations. By enabling non-ultrasonic fragmentation of even mature cataracts through a 3 mm incision in a time- and cost-efficient manner, the proposed technology has the potential to improve the acceptability and accessibility of cataract surgery in LMICs, increase the surgical volume and capacity of eye care systems, and provide improved visual and financial outcomes for the 21 million patients receiving cataract surgery annually in LMICs.

This I-Corps project represents a novel approach to address vision loss and blindness due to cataracts. Globally, 12.6 million people are blind and 52.6 million have moderate-to-severe visual impairment due to cataracts. Cataract surgery is a simple, sight-restoring procedure where the clouded lens of the eye is removed and replaced with a synthetic lens.

Cataract-related visual impairment is concentrated in low-and middle-income countries (LMICs), and is expected to grow dramatically with the aging population. The current phacoemulsification procedure involving ultrasonic cataract emulsification through a 3 mm incision is not ideal for emerging markets due to the length, cost, significant capital expense, recurring costs, and maintenance.

Moreover, phacoemulsification is not optimal for treating ultra-hard, late-stage cataracts found in LMICs which require increased ultrasound power. The proposed technology consists of a low-cost, handheld, manual cataract surgery device which addresses the limitations of phacoemulsification and has the potential to achieve comparable or improved safety and efficacy.

The device is deployed through a 3 mm incision and can capture and safely fragment all cataract sizes and hardnesses. It eliminates the need for capital equipment, maintenance, and electricity. Importantly, the device fits into the existing training and surgical workflow in emerging markets.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.