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De Jong 2009
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58c45cab7db23a0334ce5175
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4 References
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Primary study
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Ex-PRESS minishunt under scleral flap compared to standard trabeculectomy
Authors
»
De Jong LA
Journal
»
Investigative Ophthalmology and Visual Science
Year
»
2006
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The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: A prospective randomized study
Authors
»
de Jong LA
Journal
»
Advances in therapy
Year
»
2009
Links
»
Pubmed
DOI
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Introduction: The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. Methods: This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a scleral flap, or trabeculectomy. The main outcome measures were: mean intraocular pressure (IOP), postoperative medication use, visual acuity, and incidence of complications. Complete success was defined as an IOP of >4 mmHg and ≤18 mmHg without the use of antiglaucoma medications. A more stringent target of IOP >4 mmHg and ≤15 mmHg was also noted. Results: There were 78 patients (80 eyes) with primary open-angle, pseudoexfoliative, or pigmentary glaucoma enrolled in the study. A total of 84.6% of patients receiving Ex-PRESS and 60.0% of patients receiving trabeculectomy (P=0.0230) achieved complete success. The respective proportions of patients achieving an IOP >4 mmHg and ≤15 mmHg were 76.9% and 50.0% (P=0.0193). At 1-year follow-up, complete success rates were 81.8% for Ex-PRESS and 47.5% for trabeculectomy (P=0.0020), and 71.7% and 37.5% (P=0.0070), respectively, for the more stringent target. There was a similar level of postoperative interventions and complications for each group. Conclusions: In open-angle glaucoma, the Ex-PRESS mini glaucoma shunt implanted under a superficial scleral flap produces significantly higher success rates, and a similar complication rate, compared with trabeculectomy. The Ex-PRESS is a safe and effective device for treating open-angle glaucoma. © 2009 Springer Healthcare Communications.
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Primary study
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Cost-effectiveness of the Ex-PRESS glaucoma filtration device in the Netherlands
Authors
»
De Jong L
,
Lafuma A
,
Aguade AS
,
Clement O
,
Berdeaux G
Journal
»
Value in Health
Year
»
2011
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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
Authors
»
de Jong L
,
Lafuma A
,
Aguadé AS
,
Berdeaux G
Journal
»
Clinical ophthalmology (Auckland, N.Z.)
Year
»
2011
Links
»
Pubmed
DOI
PubMed Central
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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. © 2011 de Jong et al, publisher and licensee Dove Medical Press Ltd.
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Randomized controlled trial (RCT)