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      Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

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          Abstract

          Background:

          This study compared the efficacy of the EX-PRESS ® glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.

          Methods:

          Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication.

          Results:

          The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.

          Conclusion:

          This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma.

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          Most cited references20

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          The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma.

          Mae Gordon, Julia A Beiser, James Brandt … (2002)
          The Ocular Hypertension Treatment Study (OHTS) has shown that topical ocular hypotensive medication is effective in delaying or preventing the onset of primary open-angle glaucoma (POAG) in individuals with elevated intraocular pressure (ocular hypertension) and no evidence of glaucomatous damage. To describe baseline demographic and clinical factors that predict which participants in the OHTS developed POAG. Baseline demographic and clinical data were collected prior to randomization except for corneal thickness measurements, which were performed during follow-up. Proportional hazards models were used to identify factors that predicted which participants in the OHTS developed POAG. In univariate analyses, baseline factors that predicted the development of POAG included older age, race (African American), sex (male), larger vertical cup-disc ratio, larger horizontal cup-disc ratio, higher intraocular pressure, greater Humphrey visual field pattern standard deviation, heart disease, and thinner central corneal measurement. In multivariate analyses, baseline factors that predicted the development of POAG included older age, larger vertical or horizontal cup-disc ratio, higher intraocular pressure, greater pattern standard deviation, and thinner central corneal measurement. Baseline age, vertical and horizontal cup-disc ratio, pattern standard deviation, and intraocular pressure were good predictors for the onset of POAG in the OHTS. Central corneal thickness was found to be a powerful predictor for the development of POAG.
          Article 0 comments Cited 415 times – based on 0 reviews     Review now
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            Glaucoma is second leading cause of blindness globally

            Sharon Kingman (2004)
            Article 0 comments Cited 182 times – based on 0 reviews     Review now
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              Intraocular pressure fluctuation a risk factor for visual field progression at low intraocular pressures in the advanced glaucoma intervention study.

              Joseph Caprioli, Laura Coleman (2008)
              To investigate the relationship of intraocular pressure (IOP) fluctuation and mean IOP to visual field (VF) progression in patients enrolled in the Advanced Glaucoma Intervention Study (AGIS). Retrospective analysis of a prospective randomized clinical trial. Three hundred one eyes of 301 patients enrolled in the AGIS were included. Eyes with more than one surgical intervention were excluded. Worsening of the VF was detected with pointwise linear regression. Long-term IOP fluctuation was defined as the standard deviation of IOP (millimeters of mercury) at all visits after initial intervention until the time of VF worsening or end of follow-up, whichever came first. A multivariate linear regression model was performed to identify predictors of VF progression. Terciles of mean IOP were identified, and the average IOP fluctuation in each stratum was calculated. Terciles of long-term IOP fluctuation were similarly evaluated. The proportion of eyes showing VF progression in each stratum was determined and compared. Visual field progression. Visual field progression was detected in 78 eyes (26%). There were statistically significant differences, between progressing and nonprogressing eyes, for mean IOP (P = 0.006), IOP fluctuation (P<0.001), mean length of follow-up (P = 0.013), mean number of VFs (P = 0.005), and mean number of medications (P = 0.006). Three variables were associated with a higher probability of VF progression: greater IOP fluctuation (P = 0.009), argon laser trabeculoplasty (P = 0.004), and older age (P = 0.05). In this model, mean IOP was of borderline statistical significance (P = 0.09). Within the lower and upper terciles of mean IOP, IOP fluctuation was associated with VF progression in the low mean IOP group (P = 0.002) but not in the high mean IOP group (P = 0.2). When subjects were stratified according to IOP fluctuation, there was a statistically significant difference between lower and upper terciles of IOP fluctuation with respect to progression (P = 0.05). There was a weak correlation between mean IOP and IOP fluctuation (r(2) = 0.025, P = 0.01). In the AGIS, long-term IOP fluctuation is associated with VF progression in patients with low mean IOP but not in patients with high mean IOP.
              Article 0 comments Cited 133 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Ophthalmol
                Journal ID (publisher-id): Clinical Ophthalmology
                Title: Clinical Ophthalmology (Auckland, N.Z.)
                Publisher: Dove Medical Press
                ISSN (Print): 1177-5467
                ISSN (Electronic): 1177-5483
                Publication date Collection: 2011
                Publication date (Print): 2011
                Publication date (Electronic): 29 April 2011
                Volume: 5
                Pages: 527-533
                Affiliations
                [1 ]Academic Medical Centre, Ophthalmology Department, Amsterdam, The Netherlands
                [2 ]Cemka-Eval, Bourg la Reine, Paris, France
                [3 ]Alcon France, Rueil-Malmaison, Paris, France
                [4 ]Conservatoire National des Arts et Métiers, Paris, France
                Author notes
                Correspondence: Gilles Berdeaux, Alcon France, 4 rue Henri Sainte Claire Deville, 92500 Rueil-Malmaison, France, Tel +33 14 710 4860, Fax +33 14 710 2770, Email gilles.berdeaux@ 123456alconlabs.com
                Article
                Publisher ID: opth-5-527
                DOI: 10.2147/OPTH.S18565
                PMC ID: 3096614
                PubMed ID: 21607021
                SO-VID: 5f77ad88-d5a9-4424-8331-563d5c2316eb
                Copyright © © 2011 de Jong et al, publisher and licensee Dove Medical Press Ltd.
                License:

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                History
                Date received : 22 April 2011
                Categories
                Subject: Original Research

                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: glaucoma filtration device,trabeculectomy,primary open-angle glaucoma,intraocular pressure,medication
                Data availability:
                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: glaucoma filtration device, trabeculectomy, primary open-angle glaucoma, intraocular pressure, medication

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