Equinox Balance Goggles: The Effects of Local Orbital Pressure Changes on Intraocular Pressure
John Berdahl, M.D.
Technology for controlling the pressure within the eye is currently limited to ophthalmic drops, laser treatments, or surgical procedures including microinvasive glaucoma stents and very invasive procedures that create an alternative drainage pathway in the eye. None of these methods can predict how much, if any, the pressure within the eye may be changed. The Balance Goggles function by simply adding vacuum or pressure around the orbit of the eye, resulting in a normalization of the pressure differential in optic nerve diseases such as glaucoma, idiopathic intracranial hypertension (IIH), hypotony, and visual impairment and intraocular pressure (VIIP).
Dr. John Berdahl and colleagues are currently conducting a human research trial in the United States with a negative pressure application to the orbit of the eye with our product, Balance Goggles. The current study has been deemed Non-Significant Risk and is evaluating the safety of the Balance Goggles on up to 50 human patients with clinically normal eyes. The study will evaluate safety of wearing the Balance Goggles during a 30-minute time period with the negative pressure application on only one eye as compared to their control eye without a pressure application.
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This study is to confirm the safety and efficacy of the Balance Goggles on humans when subjected to a change in pressure of the microenvironment of the eye. We are currently completing a Non-Significant Risk study in the United States with up to 50 human subjects. They will be subjected to a negative pressure application of -15 ± 3 mmHg in their right eye while the left eye will have no pressure application and will be considered the control eye. Subjects will wear the goggles for exactly 30 minutes, at which time measurements of the retina and optic nerve will be taken.
We will measure the safety of the Balance Goggles by measuring intraocular pressure (IOP), tear break up time (TBUT), refraction, keratometry, axial length, biomicroscopy, and performing a peripheral retinal exam both prior to a negative pressure application and after the pressure application. We will also measure optical coherence tomography (OCT) of the optic nerve prior, during, and after administering the change in orbital pressure to determine the ability of our device to potentially change the morphology of the optic nerve head. Additionally, we will assess qualitative measures such as comfort prior, during and after administration of the pressure change treatments.
Current FDA approved methods for measuring IOP, include tonometry, which involves using air or physically touching the eye to acquire a pressure measurement. These include non-contact tonometry (commonly referred to as the “puff of air” test), or contact tonometries which include applanation of the cornea by a handheld machine or using a Goldmann applanation. Measuring IOP with these methods has one major drawback, they flatten the cornea by using air or a physical touch that gives the pressure reading an inaccurate, artificial measure of the actual pressure within the eye. Having a patient wear the Balance Goggles would not allow for an IOP measurement, due to the goggle impeding the ability to take a pressure reading. From these studies, we will be measuring how the addition of the vacuum to the study eye will correlate to a change in pressure of the microenvironment around the orbit and safety of the device assessed by adverse events. We hypothesize that by changing the pressure in the microenvironment, this will decouple the IOP from the CSF and will allow for normal axonal transport and physiology of the optic nerve.
Data will be analyzed in house by Dr. John Berdahl, Jamie Beckman, and George Tsai, comparing IOP, OCT, TBUT, refraction, keratometry, axial length, and peripheral retinal exam data. Outcomes that would confirm our hypotheses would include a significant change in IOP and cup to disc ratio. Secondary confirmations would include no significant change in TBUT, refraction, keratometry, axial length, and peripheral retinal exam. Once we are able to prove the ability to manipulate the pressure of the microenvironment in a consistent manner, we will use this data to start future clinical trials for glaucoma, IIH, hypotony, and VIIP.
Upon successful completion of the Non-Significant Risk studies, we will begin FDA trials in the United States for glaucoma, hypotony, IIH, and VIIP. The data from the Non-Significant Risk study will allow us to properly construct a proof-of-concept. Once trials have been completed, Equinox will commercialize the Balance Goggles in the United States and outside countries.
This technology has the potential to benefit glaucoma patients who cannot take currently approved medications. By using these goggles to decrease the pressure within the eye, patients may avoid surgery or the side effects of medication.