Prospective, Unmasked Evaluation of the iStent®Inject System for Open-Angle Glaucoma: Synergy Trial
Autor: | Christophe Baudouin, Lilit Voskanyan, Antonio Maria Fea, Julian Garcia-Feijoo, Anselm Jünemann, Jose I. Belda |
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Jazyk: | angličtina |
Rok vydání: | 2014 |
Předmět: |
Adult
Male Intraocular pressure medicine.medical_specialty Minimally invasive glaucoma surgery Open angle glaucoma genetic structures medicine.medical_treatment Glaucoma Trabeculectomy Cohort Studies Ophthalmology medicine Humans Pharmacology (medical) cardiovascular diseases Prospective Studies Prospective cohort study Open-angle glaucoma Glaucoma Drainage Implants Antihypertensive Agents Original Research Aged Medicine(all) Aged 80 and over Glaucoma drainage implant business.industry Ab interno General Medicine Cataract surgery Middle Aged equipment and supplies medicine.disease eye diseases Surgery Clinical trial Treatment Outcome iStent inject Female sense organs business Glaucoma Open-Angle Trabecular bypass |
Zdroj: | Advances in Therapy |
ISSN: | 1865-8652 0741-238X |
Popis: | Introduction 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. Methods 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. Results 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. Conclusion 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. Electronic supplementary material The online version of this article (doi:10.1007/s12325-014-0095-y) contains supplementary material, which is available to authorized users. |
Databáze: | OpenAIRE |
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