8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study

Thomas W Samuelson,1 Tanner J Ferguson,2 Nathan M Radcliffe,3 Richard Lewis,4 Justin Schweitzer,5 Russell Swan,5 John P Berdahl5 1Minnesota Eye Consultants, Minneapolis, MN, USA; 2Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA; 3Department of Ophthalmology, New York Eye and Ear Infirmary o...

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Autores principales:	Samuelson TW, Ferguson TJ, Radcliffe NM, Lewis R, Schweitzer J, Swan R, Berdahl JP
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	multi-pressure dial normal-tension glaucoma open-angle glaucoma glaucoma treatment Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/78c1a52b083a4c04a6ca84d5726b41de
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spelling	oai:doaj.org-article:78c1a52b083a4c04a6ca84d5726b41de2021-12-02T09:04:42Z8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study1177-5483https://doaj.org/article/78c1a52b083a4c04a6ca84d5726b41de2019-10-01T00:00:00Zhttps://www.dovepress.com/8-hrs-safety-evaluation-of-a-multi-pressure-dial-in-eyes-with-glaucoma-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Thomas W Samuelson,1 Tanner J Ferguson,2 Nathan M Radcliffe,3 Richard Lewis,4 Justin Schweitzer,5 Russell Swan,5 John P Berdahl5 1Minnesota Eye Consultants, Minneapolis, MN, USA; 2Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA; 3Department of Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA; 4Sacramento Eye Consultants, Sacramento, CA, USA; 5Vance Thompson Vision, Sioux Falls, SD, USACorrespondence: Tanner J FergusonCole Eye Institute, Cleveland Clinic, Cleveland OH, USAEmail tannerferg@gmail.comPurpose: To investigate the safety and tolerability of the multi-pressure dial with a continuous 8-hr duration in subjects with open-angle glaucoma.Design: Prospective, controlled open-label, randomized, single site study.Subjects: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with a multi-pressure dial and randomized to negative pressure application of −10 mmHg in one eye for 8 (continuous) hours and ambient atmospheric pressure in the contralateral eye.Methods: Main safety outcome measures include best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were administered both hourly during the 8-hr study period and immediately following the study period.Results: There were no statistically significant changes in IOP, BCVA or TBUT immediately following the 8-hr study period or at the 1-week follow-up visit. Patient-reported tolerability was favorable with a mean response of 1.8 ± 0.4 (scale → 1=best, 10 = worst). Subjects also reported positive interest in the MPD as a glaucoma therapy with a mean response of 1.8 ± 0.5 (scale → 1=best, 10 = worst). One adverse event was reported (headache) and resolved at conclusion of the Day 0 visit.Conclusion: The MPD demonstrated favorable safety with key parameters remaining stable after an 8-hr wear with negative pressure. Negative pressure application through the MPD was well tolerated by subjects enrolled in the study. The favorable findings demonstrate the safety of sustained delivery of negative pressure over a continuous, uninterrupted 8-hr duration.Keywords: multi-pressure dial, normal-tension glaucoma, open-angle glaucoma, glaucoma treatmentSamuelson TWFerguson TJRadcliffe NMLewis RSchweitzer JSwan RBerdahl JPDove Medical Pressarticlemulti-pressure dialnormal-tension glaucomaopen-angle glaucomaglaucoma treatmentOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 13, Pp 1947-1953 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	multi-pressure dial normal-tension glaucoma open-angle glaucoma glaucoma treatment Ophthalmology RE1-994
spellingShingle	multi-pressure dial normal-tension glaucoma open-angle glaucoma glaucoma treatment Ophthalmology RE1-994 Samuelson TW Ferguson TJ Radcliffe NM Lewis R Schweitzer J Swan R Berdahl JP 8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study
description	Thomas W Samuelson,1 Tanner J Ferguson,2 Nathan M Radcliffe,3 Richard Lewis,4 Justin Schweitzer,5 Russell Swan,5 John P Berdahl5 1Minnesota Eye Consultants, Minneapolis, MN, USA; 2Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA; 3Department of Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA; 4Sacramento Eye Consultants, Sacramento, CA, USA; 5Vance Thompson Vision, Sioux Falls, SD, USACorrespondence: Tanner J FergusonCole Eye Institute, Cleveland Clinic, Cleveland OH, USAEmail tannerferg@gmail.comPurpose: To investigate the safety and tolerability of the multi-pressure dial with a continuous 8-hr duration in subjects with open-angle glaucoma.Design: Prospective, controlled open-label, randomized, single site study.Subjects: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with a multi-pressure dial and randomized to negative pressure application of −10 mmHg in one eye for 8 (continuous) hours and ambient atmospheric pressure in the contralateral eye.Methods: Main safety outcome measures include best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were administered both hourly during the 8-hr study period and immediately following the study period.Results: There were no statistically significant changes in IOP, BCVA or TBUT immediately following the 8-hr study period or at the 1-week follow-up visit. Patient-reported tolerability was favorable with a mean response of 1.8 ± 0.4 (scale → 1=best, 10 = worst). Subjects also reported positive interest in the MPD as a glaucoma therapy with a mean response of 1.8 ± 0.5 (scale → 1=best, 10 = worst). One adverse event was reported (headache) and resolved at conclusion of the Day 0 visit.Conclusion: The MPD demonstrated favorable safety with key parameters remaining stable after an 8-hr wear with negative pressure. Negative pressure application through the MPD was well tolerated by subjects enrolled in the study. The favorable findings demonstrate the safety of sustained delivery of negative pressure over a continuous, uninterrupted 8-hr duration.Keywords: multi-pressure dial, normal-tension glaucoma, open-angle glaucoma, glaucoma treatment
format	article
author	Samuelson TW Ferguson TJ Radcliffe NM Lewis R Schweitzer J Swan R Berdahl JP
author_facet	Samuelson TW Ferguson TJ Radcliffe NM Lewis R Schweitzer J Swan R Berdahl JP
author_sort	Samuelson TW
title	8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study
title_short	8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study
title_full	8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study
title_fullStr	8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study
title_full_unstemmed	8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study
title_sort	8 hrs safety evaluation of a multi-pressure dial in eyes with glaucoma: prospective, open-label, randomized study
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/78c1a52b083a4c04a6ca84d5726b41de
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8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study

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