Negative Pressure Application via a Multi-Pressure Dial to Lower IOP in Patients with Suspected Glaucoma or Open Angle Glaucoma.

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). CONCLUSIONS: 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.

Contrast Sensitivity in Early to Intermediate Age-Related Macular Degeneration (AMD).

PURPOSE: Previous studies indicated that advanced age-related macular degeneration (AMD) affects contrast sensitivity (CS) in humans. The CS results for early/intermediate AMD patients are contradictory. The purpose of this study was to determine if CS testing discriminates early/intermediate AMD patients with normal acuity from normal patients. METHODS: Forty-nine subjects (25 control and 24 early/intermediate AMD patients) were chosen for this project. The age (p = .16) and acuity (p = .34) was not significantly different between the groups. The average simplified AREDS AMD grade for the AMD patients was 2.75 ± 1.03. Three CS functions employing a descending method of limits were measured at the fovea (1. stationary stimulus and, 2. 16 Hz counter-phase stimulus under photopic conditions and 3. the stationary stimulus viewed through a 2 log unit neutral density filter (mesopic condition, background luminance of 1 cd/m2)) and at 4 deg right or left of the fovea with a horizontally oriented sine wave grating (5 deg diameter) viewed on a VPixx monitor (luminance of 100 cd/m2). RESULTS: The early AMD patients were no different from the control patients for any test condition. The intermediate AMD patients were significantly different from the control patients for the mesopic CS function (p = .05). Post-hoc 2-sample t-tests for the intermediate AMD patients were significantly different from the control patients under the stationary photopic and mesopic conditions for the 1.5 cycle per degree stimulus. CONCLUSIONS: Group differences in CS were only found in intermediate AMD patients. The loss in CS increased for the intermediate AMD patients under low light levels. Thus, CS may not be the optimal test to discriminate early AMD from control patients so other tests measured under dark adapted conditions should be investigated.