Application of Negative Pressure by the Ocular Pressure Adjusting Pump to Provide a Sustained Reduction in IOP.

Abstract

To evaluate the sustainability of IOP reduction with continuous negative pressure application over an extended duration with use of the Ocular Pressure Adjusting Pump. Prospective, controlled, open-label, randomized, single site, pilot study. Subjects with primary open-angle glaucoma (OAG) were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. The study eye negative pressure setting was programmed for 60% of the baseline IOP. Subjects wore the Ocular Pressure Adjusting Pump for 8 consecutive hours and IOP measurements occurred at 2-hour intervals for a total of 5 IOP measurements (08:00, 10:00, 12:00, 14:00, 16:00). Nine subjects successfully enrolled and completed the study. The mean programmed negative pressure setting was -12.0mmHg. At baseline, the mean IOP in the study eye was 21.4 ± 4.3mmHg. The mean IOP reduction in the study eye at hours 0, 2, 4, 6, and 8 was 8.1 (37%), 6.4 (28%), 6.3 (29%), 7.3 (34%) and 6.7 (31%), respectively. All IOP measurements during negative pressure application were reduced from baseline. There were no serious adverse events. The Ocular Pressure Adjusting Pump provides a sustained reduction in IOP while the device is worn with negative pressure applied with an IOP reduction exceeding 25% across 8hours of continuous wear.