Abstract
BACKGROUND: This is a first-in-human study to determine the efficacy and tolerability of a new method of treating glaucoma using a low-power, low-frequency, focused therapeutic ultrasound for glaucoma (TUG) device designed to trigger an inflammatory reaction in the anterior chamber angle and trabecular meshwork to enhance outflow. The use of the device is anticipated for mild or moderate open-angle glaucoma as an enhancement to outflow. METHODS: In a two-branch clinical trial, a total of 26 primary open-angle glaucoma patients underwent a procedure consisting of the external application of the TUG device. In branch 1, nine of these patients were naïve to pharmaceutical treatment or had been off of medication for over 6 months. In branch 2, 17 patients were treated after a medication washout period. All patients in the study were followed for 12 months. RESULTS: In branch 1, there was a decrease in intraocular pressure averaging over 20% lasting at least a year in 74% of the eyes with non-normotensive open-angle glaucoma. In branch 2, an average of two visits while on medication provided the comparison intraocular pressure (IOP) to the effect of the TUG treatment after washout. It was seen that the intraocular pressure over the year post-treatment was equal to or better than the pharmaceutical control in close to 80% of measurements. CONCLUSION: A novel device for lowering intraocular pressure is described with a potential for adding to our armamentarium for treating glaucoma. This is a small cohort study which indicates beneficial trends. TRIAL REGISTRATION NUMBER: The study was a registered clinical trial, #ISRCTN50904302.