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

PURPOSE: To evaluate the sustainability of IOP reduction with continuous negative pressure application over an extended duration with use of the Ocular Pressure Adjusting Pump.

METHODS

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).

RESULTS

Nine subjects successfully enrolled and completed the study. The mean programmed negative pressure setting was -12.0 mmHg. At baseline, the mean IOP in the study eye was 21.4 ± 4.3 mmHg. 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.

CONCLUSION

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 8 hours of continuous wear.