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Abstract #126658 Published in IGR 25-2
Negative Pressure Application by the Ocular Pressure Adjusting Pump to Lower Intraocular Pressure in Normal-Tension Glaucoma: HERCULES Study
Ferguson TJ; Samuelson TW; Herndon L; Terveen DC; Bacharach J; Brubaker JW; Berdahl JP; Radcliffe NMAmerican Journal of Ophthalmology 2025; 275: 121-134
PURPOSE: To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of the ocular pressure adjusting pump in subjects with normal-tension glaucoma (NTG). DESIGN: Prospective, multicenter, masked, randomized, fellow-eye controlled trial. SUBJECTS, PARTICIPANTS, AND/OR CONTROLS: Subjects with NTG with an IOP ≥12 mm Hg and ≤21 mm Hg were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. METHODS: Subjects wore the device overnight for 1 year and the applied negative pressure was programmed by subtracting a reference IOP of 6 mm Hg from the baseline IOP. MAIN OUTCOME MEASURES: The primary effectiveness endpoint was the proportion of eyes achieving an IOP reduction ≥20% at Week 52 during the day. The secondary endpoint was the proportion of eyes achieving a nocturnal IOP reduction ≥20% at Week 52. Exploratory endpoints included mean IOP reduction in clinic and in the sleep lab. RESULTS: A total of 186 eyes were randomized across 11 sites. 120 eyes successfully completed all visits across 52 weeks without protocol deviations. At Week 52, 88.3% (n = 53) of study eyes vs 1.7% (n = 1) of control eyes met the primary endpoint. For the secondary endpoint, 96.7% (n = 58) of study eyes vs 5.0% (n = 3) met the endpoint. For exploratory IOP analysis, the mean nocturnal IOP reduction at Week 52 was 8.0 mm Hg (39.1%) from a baseline of 20.4 ± 2.5 mm Hg to 12.4 ± 2.7 mm Hg. There were no serious adverse events. The most commonly reported adverse events were lid (11.8% study, 1.1% control) and periorbital edema (12.9%, 1.1%). CONCLUSIONS: The ocular pressure adjusting pump safely and effectively lowers both daytime and nocturnal IOP in patients with NTG.
From the Vance Thompson Vision (T.J.F., D.C.T., and J.P.B.), Sioux Falls, South Dakota, USA. Electronic address: tannerferg@gmail.com.
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