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      Clinical Efficacy and Safety of the EX-PRESS Filtration Device in Patients with Advanced Neovascular Glaucoma and Proliferative Diabetic Retinopathy

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          Abstract

          Background: The prognosis of conventional filtration surgery in eyes with neovascular glaucoma (NVG) is limited due to increased fibrovascular proliferation or bleeding. This study aims to evaluate the safety and efficacy of the EX-PRESS filtration device in the management of NVG associated with proliferative diabetic retinopathy (PDR). Methods: In this retrospective case series, we reviewed the medical records of patients diagnosed as having NVG associated with PDR who underwent EX-PRESS filtration surgery. The main outcome measures were: postoperative intraocular pressure (IOP), the percent of IOP drop, the number of glaucoma medications, visual acuity, and complications of surgery. Successful surgery was defined as an IOP <22 mm Hg and >5 mm Hg with or without additional glaucoma surgery, and no loss of light perception or less than a 2-line decrease on the Snellen chart of the best corrected visual acuity (BCVA). Results: Five patients (5 eyes) were included in this study. The mean preoperative IOP was 33.4 ± 5.9 mm Hg compared to an IOP of 17.0 ± 3.0 mm Hg at the last follow-up ( p = 0.003). The mean number of preoperative anti-glaucoma medications was 3.8 ± 0.4 compared to 2.2 ± 1.5 ( p = 0.06) at the last follow-up visit. Final visual acuity improved or stabilized within 1 Snellen line in all 5 patients. Three patients had a “hypertensive phase” (defined as an IOP >21 mm Hg during the first 6 postoperative months) which resolved within 2 months. Two patients developed a hyphema that resolved spontaneously. None of the patients experienced any serious complications. Conclusion: EX-PRESS filtration device has a good IOP-lowering effect and a low rate of complications in patients with advanced NVG associated with PDR. In addition, there was no loss of light perception or no line decrease of the BCVA.

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          Most cited references26

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          Initial clinical experience with the Ahmed Glaucoma Valve implant.

          We studied the Ahmed Glaucoma Valve implant, an aqueous shunting device that has a unidirectional valve mechanism designed to prevent postoperative hypotony in eyes with intractable glaucoma. In this multicenter, prospective clinical trial, we studied 60 eyes (60 patients) with increased intraocular pressure or glaucoma that had not responded to medical treatment, laser photocoagulation, or previous glaucoma surgery, in which the Ahmed Glaucoma Valve implant was placed to decrease intraocular pressure. Success was defined as intraocular pressure less than 22 mm Hg and greater than 4 mm Hg for two months or longer, intraocular pressure that was lowered by at least 20% from preoperative values (in eyes with preoperative intraocular pressures less than 22 mm Hg), and no additional glaucoma surgery or visually devastating complications. Cumulative probability of success at 12 months was 78%. Eight (13%) of 60 eyes had intraocular pressure less than 5 mm Hg the first postoperative day. Two other eyes had shallow anterior chambers, which required anterior chamber reformation. The major complications associated with the use of the valve were serous choroidal detachments in 13 eyes (22%), blockage of the tube in six eyes (10%), malposition of the tube in four eyes (7%), a suprachoroidal hemorrhage in one eye (2%), and corneal graft rejections in three (19%) of 16 eyes with corneal grafts. Although the 12-month success with the Ahmed Glaucoma Valve implant is similar to that reported for other drainage devices, the complications associated with overfiltration in the immediate postoperative period appear to be less frequent than with other valved drainage devices. Randomized, prospective studies to compare the Ahmed Glaucoma Valve implant with other drainage devices are needed to make clinical comparisons of the different devices.
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            A clinical study of the Ahmed glaucoma valve implant in advanced glaucoma.

            To assess clinical outcomes and establish the incidence and management of a hypertensive phase (HP) (defined as intraocular pressure [IOP] > 21 mmHg in the first 6 postoperative months) in patients with Ahmed glaucoma valve implant. Retrospective noncomparative case series. A total of 85 patients were included in the current study, including consecutive patients who had intractable glaucoma and underwent Ahmed valve implant insertion at the University Glaucoma Center, Tampa, Florida (DWR and WEL) and the Massachusetts Eye and Ear Infirmary (PAN) between January 1993 and June 1997. Only patients with a minimum of 6 months' follow-up were included. Ahmed glaucoma valve implant insertion to control intractable glaucoma was performed. Success was defined as IOP less than 22 mmHg and greater than 4 mmHg on the last two visits, a decrease of no more than two lines in the visual acuity and no additional surgical interventions to control IOP. The cumulative probability of success at 12 months was 77%. A total of 26 patients (30.6%) failed during the study period, and 70 patients (82%) exhibited HP. Hypertensive phase peaked at 1 month after the operation and stabilized at 6 months. There were 34 patients (48%) with HP who were controlled with additional medications: 14 (20%) with needling and 5-fluorouracil injections and 20 (28%) who needed secondary surgical intervention. There were 8 patients (9.4%) who exhibited hypotony (< 5 mmHg) on postoperative day 1 and 3 (3.5%) at 3 months. Visual acuity returned to baseline between 3 and 6 months after the operation. The major complications associated with the valve were hyphema in 14 cases (16.5%), suprachoroidal hemorrhage in 4 cases (4.7%), end-plate exposure in 10 cases (11.7%), tube exposure in 6 cases (7%), tube block in 4 cases (4.7%), loss of vision in 5 cases (5.8%), and corneal graft failure in 4 (30%) of 13 cases with clear grafts. The overall success rate is comparable to that of prior studies using different implants. The majority of the patients exhibit an HP that peaks at 1 month, with gradual stabilization over 6 months. One third of the patients needed secondary surgical intervention to control the HP. The incidence of postoperative hypotony and flat or shallow anterior chambers is very low after Ahmed glaucoma valve insertion.
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              Increased level of vascular endothelial growth factor in aqueous humor of patients with neovascular glaucoma.

              This study aimed to quantitate and compare the concentration of vascular endothelial growth factor (VEGF) in aqueous humor samples from patients with neovascular glaucoma (NVG), primary open-angle glaucoma (POAG), and cataract, as well as in serum samples of healthy human subjects. The authors collected aqueous humor samples by using their previously published technique of limbal paracentesis. The authors determined the concentration of VEGF by using a competitive enzyme immunoassay system and four-parameter logistic curve fitting and performed statistical analysis by using the Mann-Whitney-Wilcoxon test. The authors detected VEGF in 12 of 12 samples from patients with NVG (mean +/- standard error of the mean, 29.267 +/- 7.350 ng/ml), 15 of 28 samples from patients with POAG (0.726 +/- 0.204 ng/ml), 4 of 20 aqueous humor samples from patients with cataract (0.257 +/- 0.043 ng/ml), and 16 of 16 human serum samples (20.246 +/- 1.568 ng/ml). The mean concentration of VEGF in aqueous humor of patients with NVG was 40- and 113-fold higher than that in patients with POAG and cataract, respectively, and the difference was statistically significant (P 0.05). The authors' findings show that patients with NVG had a significantly increased level of VEGF in the aqueous humor and implicate VEGF as an important factor in the pathogenesis of intraocular neovascularization in these patients. The authors discuss the possible role of the ciliary epithelium, in addition to retina, in the production of VEGF and the complementary function of basic fibroblast growth factor and other growth factors.
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                Author and article information

                Journal
                COP
                COP
                10.1159/issn.1663-2699
                Case Reports in Ophthalmology
                S. Karger AG
                1663-2699
                2018
                January – April 2018
                23 January 2018
                : 9
                : 1
                : 67-75
                Affiliations
                [_a] aDepartment of Ophthalmology, Hillel Yaffe Medical Center, affiliated to the Rappaport Faculty of Medicine, The Technion, Hadera, Israel
                [_b] bDepartment of Ophthalmology, Baruch Padeh Medical Center, affiliated to the Faculty of Medicine, Bar Ilan University, Galilee, Israel
                [_c] cDepartment of Ophthalmology, Rabin Medical Center, Beilinson Hospital, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
                Author notes
                *Rana Hanna, MD, Department of Ophthalmology, Hillel Yaffe Medical Center, Hadera (Israel), E-Mail ranaoph@gmail.com
                Author information
                https://orcid.org/0000-0003-2082-2872
                Article
                479363 PMC5892338 Case Rep Ophthalmol 2018;9:61–69
                10.1159/000479363
                PMC5892338
                29643784
                ccfcdd9c-c612-4c8d-8eaa-aad097d49be1
                © 2018 The Author(s). Published by S. Karger AG, Basel

                This article is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC). Usage and distribution for commercial purposes requires written permission. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                : 15 March 2017
                : 10 July 2017
                Page count
                Figures: 2, Tables: 2, Pages: 9
                Categories
                Case Report

                Vision sciences,Ophthalmology & Optometry,Pathology
                Proliferative diabetic retinopathy,Neovascular glaucoma,EX-PRESS device

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