Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study

Tanner J Ferguson,1 Nathan M Radcliffe,2 Sarah H Van Tassel,3 Brandon J Baartman,4 Vance M Thompson,4 Richard L Lindstrom,4,5 Mitch J Ibach,4,5 John P Berdahl4 1Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA; 2New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA; 3Department of...

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Autores principales:	Ferguson TJ, Radcliffe NM, Van Tassel SH, Baartman BJ, Thompson VM, Lindstrom RL, Ibach MJ, Berdahl JP
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	multi-pressure dial open-angle glaucoma normal-tension glaucoma nocturnal iop multi-pressure glaucoma management Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/9b7ae5d47920444996b515c1d335b85b
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spelling	oai:doaj.org-article:9b7ae5d47920444996b515c1d335b85b2021-12-02T08:55:54ZOvernight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study1177-5483https://doaj.org/article/9b7ae5d47920444996b515c1d335b85b2020-09-01T00:00:00Zhttps://www.dovepress.com/overnight-safety-evaluation-of-a-multi-pressure-dial-in-eyes-with-glau-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Tanner J Ferguson,1 Nathan M Radcliffe,2 Sarah H Van Tassel,3 Brandon J Baartman,4 Vance M Thompson,4 Richard L Lindstrom,4,5 Mitch J Ibach,4,5 John P Berdahl4 1Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA; 2New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA; 3Department of Ophthalmology, Weill Cornell Medicine, New York, NY, USA; 4Vance Thompson Vision, Sioux Falls, SD, USA; 5Minnesota Eye Consultants, Minnesota, MN, USACorrespondence: Tanner J Ferguson Email tannerferg@gmail.comPurpose: To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days.Design: Prospective, open-label, randomized, single-site study.Subjects: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of − 10 mmHg in one eye (study eye) worn overnight for 7 consecutive days.Methods: Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period.Results: Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p< 0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects’ current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable.Conclusion: The MPD can safely and comfortably be worn overnight. The decrease in IOP of > 20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.Keywords: multi-pressure dial, open-angle glaucoma, normal-tension glaucoma, nocturnal IOP, multi-pressure glaucoma managementFerguson TJRadcliffe NMVan Tassel SHBaartman BJThompson VMLindstrom RLIbach MJBerdahl JPDove Medical Pressarticlemulti-pressure dialopen-angle glaucomanormal-tension glaucomanocturnal iopmulti-pressure glaucoma managementOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 2739-2746 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	multi-pressure dial open-angle glaucoma normal-tension glaucoma nocturnal iop multi-pressure glaucoma management Ophthalmology RE1-994
spellingShingle	multi-pressure dial open-angle glaucoma normal-tension glaucoma nocturnal iop multi-pressure glaucoma management Ophthalmology RE1-994 Ferguson TJ Radcliffe NM Van Tassel SH Baartman BJ Thompson VM Lindstrom RL Ibach MJ Berdahl JP Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study
description	Tanner J Ferguson,1 Nathan M Radcliffe,2 Sarah H Van Tassel,3 Brandon J Baartman,4 Vance M Thompson,4 Richard L Lindstrom,4,5 Mitch J Ibach,4,5 John P Berdahl4 1Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA; 2New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA; 3Department of Ophthalmology, Weill Cornell Medicine, New York, NY, USA; 4Vance Thompson Vision, Sioux Falls, SD, USA; 5Minnesota Eye Consultants, Minnesota, MN, USACorrespondence: Tanner J Ferguson Email tannerferg@gmail.comPurpose: To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days.Design: Prospective, open-label, randomized, single-site study.Subjects: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of − 10 mmHg in one eye (study eye) worn overnight for 7 consecutive days.Methods: Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period.Results: Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p< 0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects’ current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable.Conclusion: The MPD can safely and comfortably be worn overnight. The decrease in IOP of > 20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.Keywords: multi-pressure dial, open-angle glaucoma, normal-tension glaucoma, nocturnal IOP, multi-pressure glaucoma management
format	article
author	Ferguson TJ Radcliffe NM Van Tassel SH Baartman BJ Thompson VM Lindstrom RL Ibach MJ Berdahl JP
author_facet	Ferguson TJ Radcliffe NM Van Tassel SH Baartman BJ Thompson VM Lindstrom RL Ibach MJ Berdahl JP
author_sort	Ferguson TJ
title	Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study
title_short	Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study
title_full	Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study
title_fullStr	Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study
title_full_unstemmed	Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study
title_sort	overnight safety evaluation of a multi-pressure dial in eyes with glaucoma: prospective, open-label, randomized study
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/9b7ae5d47920444996b515c1d335b85b
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Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study

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