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      Impact of a Glaucoma Severity Index on Results of Trabectome Surgery: Larger Pressure Reduction in More Severe Glaucoma

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          Abstract

          Purpose

          To stratify outcomes of trabectome-mediated ab interno trabeculectomy (AIT) by glaucoma severity using a simple and clinically useful glaucoma index. Based on prior data of trabectome after failed trabeculectomy, we hypothesized that more severe glaucoma might have a relatively more reduced facility compared to mild glaucoma and respond with a larger IOP reduction to trabecular meshwork ablation.

          Methods

          Patients with primary open angle glaucoma who had undergone AIT without any other same session surgery and without any second eye surgery during the following 12 months were analyzed. Eyes of patients that had less than 12 months follow up or were diagnosed with neovascular glaucoma were excluded. A glaucoma index (GI) was created to capture glaucoma severity based on visual field, number of preoperative medications, and preoperative IOP. Visual field (VF) was separated into 3 categories: mild, moderate, and advanced (assigned 1, 2, and 3 points, respectively). Preoperative number of medications (meds) was divided into 4 categories: ≤1, 2, 3 or ≥4, and assigned with a value of 1 to 4. Baseline IOP (IOP) was divided into 3 categories: <20 mmHg, 20–29 mmHg, and greater than 30 mmHg and assigned with 1 to 3 points. GI was defined as IOP × meds × VF and separated into 4 groups: <6 (Group 1), 6–12 (Group 2), >12–18 (Group 3) and >18 (Group 4). Linear regression was used to determine if there was an association between GI group and IOP reduction after one year or age, gender, race, diagnosis, cup to disc (C/D) ratio, and Shaffer grade.

          Results

          Out of 1340 patients, 843 were included in the analysis. The GI group distribution was GI1 = 164, GI2 = 202, GI3 = 260, and GI4 = 216. Mean IOP reduction after one year was 4.0±5.4, 6.4±5.8, 9.0±7.6, 12.0±8.0 mmHg for GI groups 1 to 4, respectively. Linear regression showed that IOP reduction was associated with GI group after adjusting for age, gender, race, diagnosis, cup to disc ratio, and Shaffer grade. Each GI group increase of 1 was associated with incremental IOP reductions of 2.95±0.29 mmHg. Success rate at 12 months was 90%, 77%, 77%, and 71% for GI groups 1 to 4. The log-rank test suggested significant differences between GI groups.

          Conclusion

          A simple glaucoma index, GI, was created to capture glaucoma severity and a relative resistance to treatment. A higher GI was associated with a larger IOP reduction in trabectome surgery. This indicates that there is a role for AIT beyond mild glaucoma and ocular hypertension.

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          Most cited references17

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          Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract.

          To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma. Prospective, randomized, open-label, controlled, multicenter clinical trial. A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) ≤24 mmHg controlled on 1 to 3 medications were randomized to undergo cataract surgery with iStent implantation (treatment group) or cataract surgery only (control). Fifty additional subjects were enrolled to undergo cataract surgery with iStent implantation under protocol expansion. Data in this report are based on the first 240 eyes enrolled. Implantation of the iStent trabecular micro-bypass stent in conjunction with cataract surgery or cataract surgery only. The primary efficacy measure was unmedicated IOP ≤21 mmHg at 1 year. A secondary measure was unmedicated IOP reduction ≥20% at 1 year. Safety measures included best-corrected visual acuity (BCVA), slit-lamp observations, complications, and adverse events. The study met the primary outcome, with 72% of treatment eyes versus 50% of control eyes achieving the criterion (P<0.001). At 1 year, IOP in both treatment groups was statistically significantly lower from baseline values. Sixty-six percent of treatment eyes versus 48% of control eyes achieved ≥20% IOP reduction without medication (P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects. Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            Risk factors for progression of visual field abnormalities in normal-tension glaucoma.

            To uncover risk factors for the highly variable individual rates of progression in cases of untreated normal-tension glaucoma. Visual field data were assembled from 160 subjects (160 eyes) enrolled in the collaborative normal-tension glaucoma study during intervals in which the eye under study was not receiving intraocular pressure-lowering treatment during prerandomization and postrandomization intervals. Analyses included multivariate analysis of time-dependent Cox proportional hazard, Kaplan-Meier analysis of "survival" without an increment of visual field worsening, and comparison of slopes of change in mean deviation global index over time. Most migraine occurred in women, but analysis demonstrated that gender and presence of migraine contribute separately to the overall risk. The risk ratio for migraine, adjusted for the other variables was 2.58 (P =.0058), for disk hemorrhage was 2.72 (P =.0036), and for female gender 1.85 (P =.0622). The average fall in the mean deviation index was faster in nonmigrainous women than in nonmigrainous men (P =.05). Suggesting genetic influence, Asians had a slower rate of progression (P =.005), and the few black patients enrolled had a tendency for faster progression. However, self-declared history of family with glaucoma or treated for glaucoma did not affect the rate of progression. Neither age nor the untreated level of intraocular pressure affected the rate of untreated disease progression, despite their known influence on prevalence. Whereas risk factors for prevalence help select populations within which to screen for glaucoma, the factors that affect the rate of progression help decide the expected prognosis of the individual's untreated disease and thereby the frequency of follow-up and aggressiveness of the therapy to be undertaken.
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              • Article: not found

              The structure and function relationship in glaucoma: implications for detection of progression and measurement of rates of change.

              To evaluate the relationship between change in estimated retinal ganglion cell (RGC) counts and change in measures of functional and structural damage in glaucoma, from cross-sectional data. The study included 397 eyes of 397 patients with glaucoma, suspects, and healthy individuals. All eyes underwent testing with standard automated perimetry (SAP) and spectral-domain optical coherence tomography (SD-OCT). Estimates of retinal ganglion cell (RGC) counts were obtained from SAP and SD-OCT using a previously derived algorithm. Smoothing spline curves were fitted to investigate the relationship between functional/structural parameters and RGC counts. The first derivatives (i.e., slopes) of these curves were obtained to investigate the relationship between changes in these measures. A nonlinear relationship was observed between SAP mean deviation (MD) and RGC counts. The same amount of RGC loss corresponded to largely different amounts of MD change depending on the stage of the disease. For SDOCT average retinal nerve fiber layer (RNFL) thickness, a linear relationship was seen with RGC counts throughout most of the spectrum of disease, but reaching a plateau in advanced glaucoma. Changes in RGC counts for eyes with early damage corresponded to small changes in MD, but to relatively larger changes in RNFL thickness. For eyes with advanced disease, changes in RGC counts produced relatively larger changes in MD but only small or no changes in average RNFL thickness. The analysis and interpretation of rates of SAP and SD-OCT change, as indicators of the velocity of neural damage in glaucoma, should take into account the severity of the disease.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                23 March 2016
                2016
                : 11
                : 3
                : e0151926
                Affiliations
                [001]Department of Ophthalmology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America
                Casey Eye Institute, UNITED STATES
                Author notes

                Competing Interests: NAL has received honoraria for wetlabs and lectures as a MIGS trainer from Neomedix Inc. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

                Conceived and designed the experiments: RTL NAL JSS. Performed the experiments: RTL PR NAL. Analyzed the data: RTL HP YD NAL JSS. Contributed reagents/materials/analysis tools: NAL JSS. Wrote the paper: RTL PR HP YD JSS NAL.

                Article
                PONE-D-15-47670
                10.1371/journal.pone.0151926
                4805208
                27008637
                e2e07eae-816c-42a2-a86b-70fef589fc0b
                © 2016 Loewen et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 30 October 2015
                : 7 March 2016
                Page count
                Figures: 6, Tables: 4, Pages: 12
                Funding
                This work was funded by a Research to Prevent Blindness Departmental Grant and an Individual Grant from the Department of Ophthalmology, University of Pittsburgh. The sponsor or funding organization had no role in the design or conduct of this research.
                Categories
                Research Article
                Medicine and Health Sciences
                Ophthalmology
                Eye Diseases
                Glaucoma
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Biology and Life Sciences
                Anatomy
                Head
                Eyes
                Medicine and Health Sciences
                Anatomy
                Head
                Eyes
                Biology and Life Sciences
                Anatomy
                Ocular System
                Eyes
                Medicine and Health Sciences
                Anatomy
                Ocular System
                Eyes
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                Surgical and Invasive Medical Procedures
                Ophthalmic Procedures
                People and Places
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                Steroids
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Minimally Invasive Surgery
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Musculoskeletal System Procedures
                Trabeculectomy
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                All relevant data are within the paper and its Supporting Information files.

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