Non-Invasive Intraocular Pressure Monitoring Soft Contact Lens

Novel low-cost device for accurate, non-invasive IOP monitoring using a mobile phone

Intraocular pressure contact lens
Intraocular contact lens prototype. Photo credit: ³ÉÈË´óƬ.

Background

Glaucoma is a heterogenous group of eye diseases caused by increases in intraocular pressure (IOP) that damage the optic nerve. It is the second leading cause of blindness globally and the leading cause of irreversible blindness. Global estimates of the prevalence of glaucoma were 76 million in 2020 and this is expected to increase to 111.8 million by 2040. The effects of glaucoma are gradual and progress undetected. Vision loss from glaucoma is irreversible so early detection and continuous monitoring are essential to slow the progression of disease. Goldmann applanation tonometry (GAT) is the gold standard for monitoring IOP levels. The challenge with this technique is that it requires local anesthetic, it must be performed by a trained professional and only a few readings are obtained annually. The IOP is known to fluctuate throughout the day and is impacted by several factors including changes in heart rate and body position. Additionally, the shape of the eye changes with changing IOP and this can be exploited to develop novel IOP monitoring tools. These facts support the need for an at home IOP monitoring system that provides longitudinal data. Continuous monitoring devices that accurately detect IOP fluctuations, can detect glaucoma, track its progression, and allow a more individualized therapeutic response.

Technology Overview

Queen’s researchers have developed multiple novel designs of soft contact lensesfor continuous measurement of IOP. These designs are protected by two separate patent applications with two granted US patents off the initial patent application. One set of designs contains strain-amplifying microchannels, closed or open to the atmosphere, which contain an indicator solution partially filling the microchannel. As IOP changes it alters the contact lens and causes the indicator to move through the microchannel and these changes are captured by smartphone camera. These changes are quantified by AI and accurately reflect the IOP in mmHg. The other design includes microstructures/markers in the lenses which deform in response to changes in the curvature of the lens as a result of changes in IOP. The distance between two or more markers or a change in the size and shape of a marker can be captured in digital images at two or more time periods. These changes correspond to changes in IOP.

Both contact lenses will be worn throughout the day and will be used with a smartphone camera to take images of the contact lens periodically. Machine learning algorithms in the smartphone app capture changes in the microchannel fluid and provide an absolute IOP value using (1)change in IOP in mmHg or (2)the ratio of x length and y length of contact lens microstructures. Information can be read at any time of day in either an upright or reclined position.

 Schematic of proposed lens design
Figure 1(a) Schematic of proposed lens design where the shape of the microstructures change in response to a change in IOP. (b) An illustration of the contact lens developed to monitor the IOP utilizing micro-fluidics. Changes in IOP trigger changes in corneal curvature which deforms the embedded microchannel and displaces the indicator fluid. Reference markers are used to calibrate displacement measurements. Image capture and analysis allow for calculation of changes in IOP.

IOP measurement system showing contact lens and mobile app
Figure 2 - IOP Measurement system. The microchannel contact lens-based monitoring device was evaluated to test the accuracy of the contact lenses to capture changes in IOP. Fresh enucleated porcine eyes were selected due to their similar shape and properties to the human eye. Water was inserted into the sclera of the eye using a syringe pump to manually increase IOP between 10 and 34 mm Hg. The IOP was monitored with a Miller Micro-Tio Pressure Catheter Transducer threaded into the other side of the sclera. 

Example of the fluid indicator moving to different locations at different intraocular pressure levels
Figure 3 - Example of the fluid indicator moving to different locations at different intraocular pressure levels. To track fluctuations in the IOP throughout the day, when the IOP increases the indicator fluid must travel in an anterograde direction and with decreases in IOP the fluid must travel in a retrograde direction. To study this, IOP was cycled between 10 and 40 mm Hg for a total of four cycles and the indicator fluid monitored. There was an initial decrease in indicator travel distance after the first cycle, but in subsequent cycles the indicator fluid returned to 92% of the original position for the outer tracking point and 85% for the inner tracking point.

Two charts showing the fluctuations of intraocular pressure data
Figure 4 - Ability of devices to measure fluctuating IOP. IOP was cycled between 10 and 40 mm Hg four times. The ability of the indicator fluid to return to the same positions when the pressure was decreased and increased was recorded. The indicator fluid was able to return over 92% of the way back to the original position after each cycle. 

Further details

Campigotto A, Leahy S, Zhao G, Campbell RJ, Lai Y. Non-invasive Intraocular pressure monitoring with contact lens. Br J Ophthalmol. 2020 Sep;104(9):1324-1328. 

Benefits

  • System enables acquisition of many IOP measurements over a day and longer
  • Non-invasive and inexpensive technique
  • High sensitivity, providing robust IOP measurements
  • Reproducible results with different eye shapes and sizes
  • Able to overcome variations in eye physiology

Applications

 Continuous intra-ocular pressure measurement.

Opportunity

Seeking licensing partners, research and development partners or venture funding

Patents

  • Lens Design Family 1 US 10,772,502 B2 - titled Non-Invasive Intraocular Pressure Monitor
  • US 11,684,258 B2 - titled Non-Invasive Intraocular Pressure Monitor
  • Canada patent pending serial No. 2,961,142 - titled Non-Invasive Intraocular Pressure Monitor
  • Lens Design Family 2 US patent application serial No. 17/614,157 – titled Intraocular Pressure Monitoring Contact Lens
  • EP patent application serial No. 20812566.6 – titled Intraocular Pressure Monitoring Contact Lens
  • Canada patent application serial No. 3,141,766 – titled Intraocular Pressure Monitoring Contact Lens

IP Status

Patented

Seeking

  • Development partner, 
  • Seeking investment, 
  • University spinout

Posted/updated

December 14, 2021 / December 11, 2023 (updated Technology Overview, Patents, Seeking)