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Abstract #108573 Published in IGR 23-4
Negative Pressure Application via a Multi-Pressure Dial to Lower IOP in Patients with Suspected Glaucoma or Open-Angle Glaucoma
Samuelson TW; Ferguson TJ; Brubaker JW; Bacharach J; Gallardo MJ; Chaglasian M; Comer G; Yoo PJournal of Glaucoma 2023; 32: 708-720
PRCIS: The multi-pressure dial applies localized periocular negative pressure to safely and effectively lower IOP and represents the first non-invasive, non-pharmacologic device for IOP reduction. OBJECTIVE: To evaluate the safety and effectiveness of the Multi-Pressure Dial (MPD) system, a device that applies periocular negative pressure to lower intraocular pressure (IOP). SETTING: 6 investigational sites, United States. DESIGN: Prospective, assessor-masked, randomized controlled trial. METHODS: Subjects with suspected glaucoma, ocular hypertension (OHTN), and open-angle glaucoma (OAG) with baseline IOP ≥13 mmHg and ≤32 mmHg 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. The primary effectiveness endpoint was the proportion of study eyes versus control eyes achieving an IOP reduction ≥20% at Day 90. Secondary endpoints included the proportion of eyes achieving an IOP reduction ≥25% at Day 90 as well as the proportion of eyes achieving an IOP reduction ≥20% at Days 30 and 60. RESULTS: 116 eyes of 58 subjects completed the study. At the Day 90 visit, 89.7% (n=52) of study eyes versus 3.4% (n=2) of control eyes achieved an IOP reduction ≥20% ( P <0.001). At Day 90, 77.6% (n=45) of study eyes achieved a ≥25% IOP reduction compared to 1.7% (n=1) of control eyes ( P <0.001). The most commonly reported adverse events were lid (17.2% study eye, 7.8% control eye) and periorbital edema (14.1% study eye, 10.9% control eye). CONCLUSION: This trial demonstrates that the MPD safely and effectively lowers IOP in a group of patients that included glaucoma suspects, OHTN, and patients with OAG.
Minnesota Eye Consultants, Minneapolis, MN, USA Vance Thompson Vision, Sioux Falls, SD, USA Sacramento Eye Consultants, Sacramento, CA, USA North Bay Eye Associates, Sonoma County, CA, USA El Paso Eye Surgeons, El Paso, TX, USA University of Texas Health Sciences Center, San Antonio, TX, USA Illinois College of Optometry, Chicago, IL, USA Southern California College of Optometry, Fullerton, CA, USA Equinox Ophthalmic, Inc., Newport Beach, CA, USA.
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