Eight hrs safety evaluation of a multi-pressure dial in eyes with glaucoma: Prospective, open-label, randomized study
Clinical Ophthalmology Oct 05, 2019
Samuelson TW, Ferguson TJ, Radcliffe NM, et al. - In patients with open-angle glaucoma, researchers conducted this prospective, controlled open-label, randomized, single-site study to test the safety and tolerability of the multi-pressure dial (MPD) with a continuous 8-hr duration. In this anlysis, 20 eyes of 10 individuals with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of −10 mmHg in one eye for 8 (continuous) hours and ambient atmospheric pressure in the contralateral eye. No statistically significant changes were observed in intraocular pressure, best-corrected visual acuity or tear break-up time immediately following the 8-hr study period or at the 1-week follow-up visit. According to findings, the MPD showed favorable safety with key parameters remaining stable after an 8-hr wear with negative pressure. Negative pressure application through the MPD was well tolerated by study participants. The positive results show the safety of sustained negative pressure delivery over a constant, uninterrupted 8-hour period.
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