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. 2021 Jun;10(2):349-358.
doi: 10.1007/s40123-021-00343-4. Epub 2021 Apr 19.

Short-term Evaluation of Negative Pressure Applied by the Multi-Pressure Dial System to Lower Nocturnal IOP: A Prospective, Controlled, Intra-subject Study

Jeffrey L Goldberg  1 , Jesus Jiminez-Roman  2 , Alejandra Hernandez-Oteyza  3 , Hugo Quiroz-Mercado  4
Affiliations

Short-term Evaluation of Negative Pressure Applied by the Multi-Pressure Dial System to Lower Nocturnal IOP: A Prospective, Controlled, Intra-subject Study

Jeffrey L Goldberg et al. Ophthalmol Ther. 2021 Jun.

Abstract

Introduction: The purpose of this study was to investigate the short-term safety and feasibility of negative pressure application by the Multi-Pressure Dial (MPD) System to lower nocturnal intraocular pressure (IOP) in subjects with open-angle glaucoma (OAG).

Methods: A prospective, controlled, intra-subject study of 22 eyes from 11 subjects at a single site was performed. All subjects had a history of OAG and were currently using a topical prostaglandin. For each subject, the eye with the highest IOP in the supine position was selected as the treatment eye (TE) and the contralateral eye served as the control eye (CE). The negative pressure for the TE was set to 60% of the baseline IOP value with no negative pressure in the CE. IOP measurements were collected at three prespecified time points overnight in the supine position with active negative pressure. The primary outcome measure was mean IOP with the application of negative pressure.

Results: At the three overnight time points, the mean (± standard deviation) baseline IOP prior to negative pressure application was 22.2 ± 2.5 mmHg in the TE and 21.8 ± 2.5 mmHg in the CE. With the application of 60% negative pressure to the TE and no active negative pressure to the CE, the mean IOP was 14.2 ± 2.2 and 19.5 ± 2.4 mmHg, respectively. The mean percentage IOP reduction in the TE was 35% (p < 0.001). There were two minor adverse events, both unrelated to device wear, and there were no IOP spikes ≥ 10 mmHg.

Conclusion: The MPD can safely and effectively lower nocturnal IOP in the supine position. The MPD holds promise as a potential new, non-invasive treatment option for the control of nocturnal IOP.

Keywords: Multi-pressure dial; Multi-pressure glaucoma management; Nocturnal IOP; Normal-tension glaucoma; Open-angle glaucoma.

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Figures

Fig. 1
Fig. 1
The Excursion Multi-Pressure Dial system. The pneumatonometer is inserted through the open, distal end of the access port and gently placed against the tono-pen cover on the cornea to obtain an intraocular pressure measurement
Fig. 2
Fig. 2
The mean intraocular pressure (IOP) results for all three time points for the treatment eye and control eye. Of note, the negative pressure (NP) setting for the control eye was 0 mmHg. The far right group of bars shows the mean IOP across all three time points for the treatment eye and control eye
Fig. 3
Fig. 3
Comparison of the percentage of IOP reduction in the treatment eye and control eye for each subject (subjects 1–11). It is noted that 9 of the 11 subjects achieved a > 30% IOP reduction in the treatment eye with the application of negative pressure
See this image and copyright information in PMC

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