Short-Term Safety Evaluation of a Multi-Pressure Dial: A Prospective, Open-label, Non-randomized Study

• DOI: 10.1007/s40123-019-0181-y
• Publication Date: 2019-03-27T19:42:29Z
• Authors: Vance M. Thompson; Tanner J. Ferguson; Iqbal Ike K. Ahmed; Thomas W. Samuelson; Russell J. Swan; Mitch Ibach; John P. Berdahl
• Keywords: Tolerability; Fundus (uterus)

Prospective, open-label, non-randomized, single site study to assess the safety and tolerability of a multi-pressure dial. 30 healthy subjects received application negative pressure (–15 mmHg) in one eye for minutes ambient atmospheric contralateral eye. To evaluate safety, primary outcome measures included best corrected visual acuity (BCVA), intraocular (IOP) changes from baseline, slit-lamp dilated fundus examination findings, rate adverse events. Exploratory analyses this also evaluated baseline measurement tear break-up time (TBUT) RNFL thickness measured by OCT. In addition screening, underwent testing on day 0 returned 1 week after initial visit clinical testing. The follow-up did not include use dial (MPD) but repeated No events were reported study. After short-term wear MPD 0, there was minimal statistically significant increase half line (LogMAR) BCDVA eyes; present at week. There no observed cup-disk ratio TBUT reduction both fellow eyes following study, significance has yet be determined. MPD, which consists pair goggles connected handheld, programmable pump, well tolerated enrolled Key parameters remained stable exposure. favorable results support profile promote further investigation device as potential treatment glaucoma. Equinox Ophthalmic, Inc. (Newport Beach, CA).