Julian García-Feijoo1, Magda Rau2, Swaantje Grisanti3, Salvatore Grisanti4, Helmut Höh5, Carl Erb6, Pravoslava Guguchkova7, Iqbal Ahmed8, Günther Grabner9, Herbert Reitsamer9, Tarek Shaarawy10, Tsontcho Ianchulev11. 1. Instituto de Investigación, Biomedica Hospital Clinico San Carlos, UCM, Oftared, Madrid, Spain. 2. Eye Clinic, Cham, Germany. 3. University Clinic Schleswig-Holstein, Luebeck, Germany. 4. Eye Hospital, Luebeck, Germany. 5. Eye Hospital at the Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Germany; Teaching Hospital of the Ernst-Moritz-Arndt University of Greifswald, Greifswald, Germany. 6. Eye Clinic Wittenbergplatz, Berlin, Germany. 7. Eye Clinic of Sofia, Sofia, Bulgaria. 8. University of Toronto, Toronto, Canada. 9. Paracelsus Medical University, Salzburg, Austria. 10. University of Geneva, Geneva, Switzerland. 11. University of California at San Francisco, San Francisco, California. Electronic address: sianchulev@transcendmedical.com.
Abstract
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 < .0001). Mean medication usage also decreased from baseline to a mean of 1.4 ± 1.3 medications at 12M (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.
RCT Entities:
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 < .0001). Mean medication usage also decreased from baseline to a mean of 1.4 ± 1.3 medications at 12M (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.
Authors: Daniel C Terveen; Steven R Sarkisian; Steven D Vold; Deepan Selvadurai; Blake K Williamson; Deborah G Ristvedt; Adam R Bleeker; Kavita Dhamdhere; Jaime E Dickerson Journal: Int Ophthalmol Date: 2022-10-13 Impact factor: 2.029
Authors: José Ignacio Fernández-Vigo; Julián García-Feijóo; José María Martínez-de-la-Casa; Javier García-Bella; Pedro Arriola-Villalobos; Cristina Fernández-Pérez; José Ángel Fernández-Vigo Journal: BMC Ophthalmol Date: 2016-04-18 Impact factor: 2.209