1. Clinical Study of the IOPTx™ System - an Electroceutical Wearable to Lower Intraocular Pressure.
- Author
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Shah, Jay V., Albors, Gabriel O., Williams, Jack, Yuan, Quan, Milla, Elena, Firestone, Murray I., Simón, Gabriel, and Irazoqui, Pedro P.
- Subjects
INTRAOCULAR pressure ,OCULAR hypotony ,OCULAR hypertension ,EYE examination ,EYE protection ,REST ,SYSTEM safety ,FILTERING surgery - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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