Clinical Study of the IOPTx™ System - an Electroceutical Wearable to Lower Intraocular Pressure

ABSTRACT

Purpose: To investigate the safety and efficacy of the IOPTx™ system – a novel wearable, electroceutical treatment to lower intraocular pressure. Methods: Patients wear the customized contact lens and spectacles of the IOPTx™ system and undergo three 15-minute randomized stimulation trials at different stimulus amplitudes with 15 minutes of rest in between. The parameters for the stimulation trials include a frequency of 50 Hz, a pulse width of 100 µs, and current amplitudes between 90–150 µA. The optometrist measures the intraocular pressure (IOP) before, immediately after, and 15 minutes after the trial, and performs topography, a slit eye examination, and specular microscopy before and after the entire study to check the health of the eye and confirm the safety of the system. Results: The IOPTx™ system successfully modulates a patient’s IOP. By testing various currents, we create individual tuning curves examining the effect of the stimulation amplitude on the change in IOP. Each patient may have an optimal dose-response curve and by normalizing to this value, the IOPTx™ system decreased IOP by an average of 17.7% with fifteen minutes of therapy. No Adverse Events or Adverse Device Effects occurred.Conclusions: The results of this clinical case series provide preliminary evidence of efficacy and safety of the IOPTx™ system and its potential usefulness to lower IOP in glaucoma and ocular hypertension.

KEYWORDS:

• Glaucoma
• electroceutical
• stimulation
• IOP
• wearable device

Acknowledgments

The authors would like to thank Brett Collar for fabricating the custom contact lens sandwich, Curtis Slaubaugh for developing the GUI, and Jorge Tort for taking IOP measurements.

Declaration of interest

GOA, MIF, and PPI received personal fees and other from Bionode LLC. JVS and GS received other from Bionode LLC. JW, QY, GOA, GS, and PPI have a patent issued and licensed (Wireless Glaucoma Therapy).

Additional information

Funding

This study was funded by a grant from Bionode, LLC.