PROJECT SUMMARY/ABSTRACT
Glaucoma, which is often referred to as the "silent thief of sight," gradually steals vision without early warning
signs or pain, and it remains the leading cause of blindness worldwide. Currently, the only known method to slow
the progression of glaucoma is to reduce intraocular pressure (IOP), which helps to minimize permanent damage
to the optic nerve. However, IOP levels can fluctuate over both daily and seasonal periods, with the greatest
peaks often occurring during sleep or in a supine position. In turn, vision loss may occur during sleep, without
the patient being aware of it, even if their IOP levels are normal during daytime measurements taken in clinical
or home settings. Assessing the 24-hour pattern of IOP on a regular basis, daily, weekly, and monthly can be
highly beneficial for patients with glaucoma or those who are at risk of developing the condition, which is however
lacking in standard clinical practice. Although wearable ocular tonometers, such as the Triggerfish lens
(Sensimed, Inc.), aim to continuously monitor IOP in both clinical and home settings, their long-term use in
human eyes is currently limited, particularly during sleep, due to various side effects such as foreign body
sensation, eye pain, superficial punctate keratitis, corneal epithelial defects, and conjunctival erythema. To
address this unmet need, we propose to develop and optimize a unique class of smart soft contact lenses that
build upon existing commercial brands of soft contact lenses, without altering their intrinsic properties, including
lens power, biocompatibility, softness, transparency, wettability, oxygen transmissibility, and overnight
wearability. We anticipate that the smart soft contact lenses will offer a number of advantages over existing
wearable ocular tonometers, including superior safety, user comfort, lens fit, visual field, ease of use, overnight
wearability, and measurement accuracy. To this end, we will produce various prototypes of the smart soft contact
lenses and then iteratively conduct a comprehensive set of in vitro, ex vivo, and in vivo tests to assess several
key features. These include: (1) durability against perpetual cycles of mechanical loads such as flipping, folding,
and stretching, chemical treatments such as cleaning and disinfecting, and other possible user mishandling such
as dehydration, overheating, or overcooling; (2) in vitro cell viability on human corneal cells; (3) ex vivo sensing
performance in enucleated pig eyes; (4) in vivo sensing performance in dogs (without euthanasia); and (5) clinical
validity in human eyes, both in-clinic and at-home settings. We will compare the measurement results with those
obtained from the in-clinic, portable, and wearable types of current ocular tonometers such as the Goldmann
applanation tonometry (GAT), I-Care Home (I-Care, Inc.), and Triggerfish lens (Sensimed, Inc.). We envision the
smart soft contact lenses to provide continuous, 24-hour monitoring of IOP that is well-tolerated by the majority
of glaucoma patients and those suspected to have the condition. Successful outcomes of this project may also
present opportunities to broaden the use of smart soft contact lenses beyond glaucoma management, opening
the door to the continuous monitoring of other chronic ocular diseases, such as cataract and age-related macular
degeneration.