Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial
Voskanyan L, Garcia-Feijoo J, Belda JI, Fea A, Jünemann A, Baudouin C (2014)
Publication Type: Journal article
Publication year: 2014
Journal
Book Volume: 31
Pages Range: 189-201
Journal Issue: 2
DOI: 10.1007/s12325-014-0095-y
Abstract
Micro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain.In this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit.Sixty-six percent of subjects achieved IOP <=18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP <= 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects.In this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.
Authors with CRIS profile
Involved external institutions
Universidad Complutense de Madrid (UCM)
Spain (ES)
University of Turin / Università degli Studi di Torino (UNITO)
Italy (IT)
Quinze-Vingts National Ophtalmology Hospital / Centre hospitalier national d’ophtalmologie des Quinze-Vingts
France (FR)
Hospital Universitario de Torrevieja
Spain (ES)
S.V. Malayan's Eye Center
Armenia (AM)
Spain (ES)
University of Turin / Università degli Studi di Torino (UNITO)
Italy (IT)
Quinze-Vingts National Ophtalmology Hospital / Centre hospitalier national d’ophtalmologie des Quinze-Vingts
France (FR)
Hospital Universitario de Torrevieja
Spain (ES)
S.V. Malayan's Eye Center
Armenia (AM)
How to cite
APA:
Voskanyan, L., Garcia-Feijoo, J., Belda, J.I., Fea, A., Jünemann, A., & Baudouin, C. (2014). Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial. Advances in Therapy, 31(2), 189-201. https://doi.org/10.1007/s12325-014-0095-y
MLA:
Voskanyan, Lilit, et al. "Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial." Advances in Therapy 31.2 (2014): 189-201.
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