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Randomized Controlled Trial
. 2020 Nov 13;9(12):19.
doi: 10.1167/tvst.9.12.19. eCollection 2020 Nov.

Evaluation of the IOP-Lowering Effect of a Multi-Pressure Dial at Different Negative Pressure Settings

Russell J Swan  1 , Tanner J Ferguson  2 , Manjool Shah  3 , Kelly W Muir  4 , Thomas W Samuelson  5 , Iqbal Ike K Ahmed  6 , Richard L Lindstrom  5 , Nathan M Radcliffe  7 , John P Berdahl  1
Affiliations
Randomized Controlled Trial

Evaluation of the IOP-Lowering Effect of a Multi-Pressure Dial at Different Negative Pressure Settings

Russell J Swan et al. Transl Vis Sci Technol. .

Abstract

Purpose: To evaluate the intraocular pressure (IOP)-lowering effect of a multi-pressure dial (MPD) at targeted negative pressure settings.

Methods: Prospective, intrasubject controlled study of 65 healthy subjects randomized to receive no negative pressure for 60 minutes or negative pressure application at designated levels of 25%, 50%, and 75% of baseline IOP for 20 minutes each. The main outcome measure was mean IOP with application of negative pressure.

Results: In the study eye group, from a baseline IOP of 15.8 ± 3.6 mm Hg, the mean IOP was 13.5 ± 3.4, 11.5 ± 3.1, and 10.2 ± 2.7 mm Hg with negative pressure settings of 25%, 50% and 75%, respectively. In the control eye group, from a baseline IOP of 15.5 ± 3.0 mm Hg, the mean IOP values at the same time points, without negative pressure, were 15.6 ± 3.0, 15.5 ± 2.5 and 15.3 ± 2.4 mm Hg. The difference between the mean IOPs of the two groups was significantly different at all negative pressure settings (P < 0.001) in comparison with baseline. There was one minor adverse event, a corneal abrasion, that was unrelated to device wear.

Conclusions: Negative pressure application to the periocular space with a multi-pressure dial can produce titratable IOP reduction while the device is worn with active negative pressure. To our knowledge, this technology represents the first nonpharmacologic, nonlaser, nonsurgical method for IOP reduction.

Translational relevance: This represents the first study demonstrating the IOP-lowering ability of the multi-pressure dial, a device that uses a novel IOP-lowering strategy by delivering negative pressure to the periocular region.

Keywords: CSF pressure; MPD; multi-pressure dial; multi-pressure glaucoma management; normal tension glaucoma; open-angle glaucoma; severe open-angle glaucoma.

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Conflict of interest statement

Disclosure: R.J. Swan, Equinox Ophthalmic, Inc. (C); T.J. Ferguson, Equinox Ophthalmic, Inc. (C); M. Shah, None; K.W. Muir, None; T.W. Samuelson, Equinox Ophthalmic, Inc. (C); I.I.K. Ahmed, Equinox Ophthalmic, Inc. (C); R.L. Lindstrom, Equinox Ophthalmic, Inc. (C); N.M. Radcliffe, Equinox Ophthalmic, Inc. (C); J.P. Berdahl, Equinox Ophthalmic, Inc. (I)

Figures

Figure 1.
Figure 1.
Excursion MPD, an adaptation of the MPD that allows for IOP measurement while negative pressure is active, which includes the goggles and the pressure-modulating pump with crush-resistant tubing that permits independent negative pressure settings for each eye.
Figure 2.
Figure 2.
How the pneumatonometer is inserted through the access port on the Excursion MPD, a modified version of the MPD that facilitates IOP measurement during wear via pneumatonometry across a Tono-Pen tip cover acting as a membrane.
Figure 3.
Figure 3.
The comparison of the mean IOP via pneumatonometry during the study period in both the study and control eye. The baseline value (far left) represents the IOP measurements obtained before wear of the MPD. Only the study eye underwent application of negative pressure. NP = negative pressure; MPD OFF indicates the device was not being worn by the subject during IOP measurement. *The difference between the study and control eye at these time points (25%, 50%, 75%) was statistically significantly different (P < 0.001) than the IOP difference between the study and control eye before the application of negative pressure.
See this image and copyright information in PMC

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