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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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          Abstract

          Purpose

          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.

          Related collections

          Most cited references 10

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          Cerebrospinal fluid pressure in glaucoma: a prospective study.

          To assess whether a low cerebrospinal fluid pressure (CSF-P) is associated with open-angle glaucoma in eyes with normal intraocular pressure (IOP). Prospective, interventional study. The study included 43 patients with open-angle glaucoma (14 with a normal IOP, and 29 with an elevated IOP) and 71 subjects without glaucoma. All patients underwent standardized ophthalmologic and neurologic examinations and measurement of lumbar CSF-P. Cerebrospinal fluid pressure and IOP. Lumbar CSF-P was significantly (P<0.001) lower in the normal IOP glaucoma group (9.5+/-2.2 mmHg) than in the high IOP glaucoma group (11.7+/-2.7 mmHg) or the control group (12.9+/-1.9 mmHg). The trans-lamina cribrosa pressure difference (IOP minus CSF-P) was significantly (P<0.001) higher in the normal IOP glaucoma group (6.6+/-3.6 mmHg) and the high-IOP glaucoma group (12.5+/-4.1 mmHg) than in the control group (1.4+/-1.7 mmHg). The extent of glaucomatous visual field loss was negatively correlated with the height of the CSF-P and positively correlated with the trans-lamina cribrosa pressure difference. In the control group, CSF-P was significantly correlated with both systolic blood pressure (P = 0.04) and IOP (P<0.001). The trans-lamina cribrosa pressure difference was not significantly associated with blood pressure (P = 0.97). In open-angle glaucoma with normal IOP, CSF-P is abnormally low, leading to an abnormally high trans-lamina cribrosa pressure difference. Pathogenetically, a low CSF-P in normal-IOP glaucoma may be similar to a high IOP in high-IOP glaucoma. Consequently, the glaucomatous visual field defect is positively correlated with the trans-lamina cribrosa pressure difference and inversely correlated with the CSF-P. In nonglaucomatous subjects, CSF-P, blood pressure, and IOP are significantly associated with each other. Copyright (c) 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma.

            To compare cerebrospinal fluid (CSF) pressure in patients with primary open-angle glaucoma (POAG) with that in nonglaucomatous patients. Case-control study. Thirty-one thousand, seven hundred and eighty-six subjects underwent lumbar puncture (LP) between 1996 and 2007 at the Mayo Clinic, Rochester, Minnesota. Of these, 28 patients who had POAG and 49 patients who did not have POAG were analyzed. Retrospective review of medical records. Comparison of the 2 groups and factors associated with CSF pressure were analyzed by univariate and multivariate analyses. Demographics (age and gender), medical history, medication use, indication for LP, intraocular pressure (IOP), optic disc cup-to-disc ratio, visual field assessment, and CSF pressure. The mean CSF pressure +/- standard deviation was 13.0+/-4.2 mmHg in nonglaucoma patients and 9.2+/-2.9 mmHg in POAG patients (P<0.00005). The CSF pressure was lower in POAG patients regardless of indication for LP or age. Linear regression analysis showed that cup-to-disc ratio correlated independently with IOP (P<0.0001), CSF pressure (P<0.0001), and the translaminar pressure difference (P<0.0001). Multivariate analysis demonstrated that larger cup-to-disc ratio (P<0.0001) was associated with lower CSF pressure. Cerebrospinal fluid pressure is significantly lower in POAG patients compared with that in nonglaucomatous controls. These data support the notion that CSF pressure may play an important contributory role in the pathogenesis of POAG.
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              Chronic experimental glaucoma in primates. II. Effect of extended intraocular pressure elevation on optic nerve head and axonal transport.

              Intraocular pressure (IOP) elevations lasting from 2 to 42 days were produced in 13 primate eyes by anterior chamber injections of autologous, fixed red blood cells. The retina, optic nerve head, and optic nerves were studied by electron microscopy, and ganglion cell rapid axonal transport was examined after IOP elevations for various durations. Transport of axonal material was blocked at the scleral lamina cribrosa by IOP elevations to 50 mm Hg. With IOP elevation for less than 1 week, return to normal IOP restored normal transport in some axons. However, in other axons IOP elevation for less than 1 week intiated ganglion cell degeneration. The process of cellular death involved a rapid ascending degeneration from nerve head to brain, followed 3 to 4 weeks later by descending degeneration of the ganglion cell body and its attached axon. Axons of the superior and inferior optic nerve head and nerve seem to be damaged more extensively than those in the nasal and temporal optic nerve. Two to four days after IOP elevation, axons of the superficial optic nerve head were swollen with accumulating axonal material, leading to histologic disk edema. In those eyes with IOP elevation longer than 1 week, the loss of anterior disk nerve fibers combined with posterior and lateral movement of the lamina cribrosa lead to an increase in optic disk cupping. Astrocytes and capillaries of the optic nerve head seem to tolerate elevated IOP well and were relatively spared.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                OPTH
                clinop
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove
                1177-5467
                1177-5483
                02 October 2019
                2019
                : 13
                : 1947-1953
                Affiliations
                [1 ]Minnesota Eye Consultants , Minneapolis, MN, USA
                [2 ]Cole Eye Institute, Cleveland Clinic , Cleveland, OH, USA
                [3 ]Department of Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai , New York, NY, USA
                [4 ]Sacramento Eye Consultants , Sacramento, CA, USA
                [5 ]Vance Thompson Vision , Sioux Falls, SD, USA
                Author notes
                Correspondence: Tanner J Ferguson Cole Eye Institute, Cleveland Clinic , ClevelandOH, USA Email tannerferg@gmail.com
                Article
                217736
                10.2147/OPTH.S217736
                6778771
                © 2019 Samuelson et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 2, Tables: 3, References: 20, Pages: 7
                Categories
                Original Research

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