Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study
| Autor: | Günther Grabner, Iqbal Ike K. Ahmed, Tarek Shaarawy, S. Grisanti, Tsontcho Ianchulev, Salvatore Grisanti, Carl Erb, Helmut Höh, Magda Rau, Pravoslava Guguchkova, Herbert A. Reitsamer, Julian Garcia-Feijoo |
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| Rok vydání: | 2015 |
| Předmět: |
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medicine.medical_specialty Intraocular pressure genetic structures Open angle glaucoma Visual Acuity/physiology medicine.medical_treatment Gonioscopy Glaucoma Ciliary Body/surgery Glaucoma Open-Angle/drug therapy/physiopathology/surgery Prosthesis Implantation Tonometry Ocular Refractory Ophthalmology Intraocular Pressure/drug effects/physiology medicine Glaucoma surgery Humans Single-Blind Method cardiovascular diseases Prospective Studies Treatment Failure Glaucoma Drainage Implants Adverse effect Hyphema Aged Antihypertensive Agents/therapeutic use business.industry Middle Aged equipment and supplies Prognosis medicine.disease eye diseases ddc:616.8 Surgery surgical procedures operative Female Stents sense organs business Uveitis |
| Zdroj: | American Journal of Ophthalmology, Vol. 159, No 6 (2015) pp. 1075-1081.e1 |
| ISSN: | 0002-9394 |
| DOI: | 10.1016/j.ajo.2015.02.018 |
| Popis: | Purpose To evaluate the safety and efficacy of a supraciliary micro-stent (CyPass Micro-Stent; Transcend Medical, Menlo Park, California, USA) for surgical treatment of glaucoma in patients refractory to topical medications. Design Multicenter, single-arm interventional study. Methods Patients with open-angle glaucoma (Shaffer Grade 3 and 4) and uncontrolled medicated intraocular pressure (IOP) >21 mm Hg at baseline and candidates for conventional glaucoma surgery were enrolled. Glaucoma medications were discontinued at surgery and resumed at investigator discretion. CyPass Micro-Stent implantation was completed in all patients using a standard clear corneal approach. Adverse events, postoperative IOP changes, and need for IOP-lowering medications during the first 12 postoperative months (12M) were monitored. Results Sixty-five eyes were enrolled, and 55 were available at 12M, accounting for loss to follow-up and early termination. Baseline IOP was 24.5 ± 2.8 mm Hg, and the mean number of medications recorded was 2.2 ± 1.1. There were no serious intraoperative events or major adverse events (eg, retinal or choroidal detachment, persistent uveitis, persistent hyphema, hypotony maculopathy). The most common adverse events included IOP increases >30 mm Hg beyond 1 month (11%, 7/65), transient hyphema (6%, 4/65), and cataract progression (12%, 5/41 phakic eyes). Mean IOP was 16.4 ± 5.5 mm Hg at 12 months—a 34.7% reduction ( P P = .002). In eyes originally indicated for conventional glaucoma surgery, no secondary surgery was performed in 83% (53/64). Conclusion Supraciliary stenting with the CyPass Micro-Stent effectively lowers IOP as a surgical treatment for glaucoma, precluding the need for more invasive glaucoma surgery in >80% of patients at 1 year, thereby reducing postoperative glaucoma surgical complications. |
| Databáze: | OpenAIRE |
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