Cutting Edge Glaucoma - Issue 2

42 • CUTTING EDGE - GLAUCOMA this study [46]. At the time of initiation of this study, the gelatin stent was very new on the market and no best practices were established, so the study results also reflect the investigators’ learning curve with the surgery [46] and the variation in pre- and postoperative regimens associated with typical clinical settings. Another potential limitation is the fact that < 5% of the study population was of Asian and Black/African ethnicity (reported to have a higher risk of failure with trabeculec- tomy) [48–50]. Nevertheless, the results of this study demonstrate a favorable risk/benefit profile when compared with those published for more invasive surgeries like tube/trabeculectomy. Our findings are generalizable to eyes with POAG uncontrolled with topical hypotensive agents and provide evidence that can help clinical decision making. As first surgical intervention, the gelatin implant was effective over 2 years in reducing both IOP and medication needs in patients with moderate POAG uncontrolled topically, with an acceptable safety profile. Used alone or in combination with cataract surgery, the gelatin implant lends itself to use earlier in the treatment paradigm, offering a minimally invasive surgical alter- native for patients with target IOP in the mid-low teens who are uncontrolled on topical therapy or whose quality of life is low on topical polytherapy, as well as those who are non-adherent or intolerant to topical therapy. Acknowledgments The authors would like to recognize the contributions of Zhanying Bai, M.S. and Charlie Wu, M.S. (employees of Allergan) for their support with the statistical analyses and programming, Andrew Shirlaw, M.S. (employee of Allergan) for his contribution to study project management, as well as Mini Balaram, M.D. (employee of Allergan) for her contribution to the manuscript development. Writing/editorial assistance was provided to the authors by Michele Jacob, Ph.D., CMPP, of Evidence Scientific Solutions, Inc. (Philadelphia, Pennsylvania) and funded by Allergan plc (Dublin, Ireland). All authors met the ICMJE authorship criteria. Neither hono- raria nor payments were made for authorship. APEX Study Group Ejaz Ansari, M.D. (Maidstone Hospital, Eye, Ear, and Mouth Unit, Maidstone Kent, England). Leon Au, M.D. (Department of Eye Research, Manchester Royal Eye Hospital, Manchester, England). Keith Barton, M.D., CP FCRS, FRCOphth (Moorfields Eye Hospital, London, England). H. Burkhard Dick, M.D., Ph.D., FEBOS-CR (University Eye Clinic Bochum, Bochum, Germany). Luis Cadarso, M.D. (Ophthalmology Department, Clínica Oftalmológica Dr. Cadarso, Pontevedra, Spain). Antonio Fea, M.D. (Instituto di Fisiopatologia Clinica, Clinica Oculistica, Universita’ di Torino, Torino, Italy). Fritz Hengerer, M.D. (Klinik für Augenheilkunde, Frankfurt, Germany). Helmut Höh, M.D., FEBO (Department of Ophthalmology, DietrichBonhoeffer-Klinikum, Neubrandenburg, Germany). Cosme LavinDapena, M.D. (Hospital Universitario La Paz, Madrid, Spain). Kin Sheng Lim, MBChB, M.D., FRCOphth (Ophthalmology Department, St Thomas’ Hospital, London, England). Giorgio Marchini, M.D. (University Eye Clinic, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy). Imran Masood, M.D. (Birmingham Midland Eye Theaters, West Midlands, England). Georg Mossböck, M.D. (Medical University Graz, Graz, Austria). Madhu Nagar, M.D. (Clinical Research Team, Pinderfields Hospital, Wakefield, England). Marco Nardi, M.D. (University of Pisa, Pisa, Italy). Herbert Reitsamer, M.D. (Department of Ophthalmology and Optometry, University Clinic Salzburg, SALK/Paracelsus Medical University, Salzburg, Austria). Marek Rękas, M.D., Ph.D. (Ophthalmology Department of the Military Health Service Institute, Warsaw, Poland). Tarek Shaarawy, M.D. (University of Geneva, Geneva, Switzerland). Ingeborg Stalmans, M.D., Ph.D. (Department of Ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium). Miguel M.D., Teus, (Hospital Universitario Principe de Asturias, Madrid, Spain). Clemens Vass, M.D. (Vienna University, Vienna, Austria). Funding information This study was funded by Allergan plc (Dublin, Ireland; formerly AqueSys, Inc.). Compliance with ethical standards Conflict of interest Herbert Reitsamer has received consulting honoraria from Allergan. Chelvin Sng has received consulting honoraria from Allergan, Glaukos (San Clemente, California), Alcon (Fort Worth Texas), and Santen Pharmaceuticals (Osaka, Japan). Vanessa Vera has received consulting honoraria from Allergan. Keith Barton has received consulting honoraria from Alcon, Allergan, and Glaukos. Ingeborg Stalmans has received consulting honoraria from Allergan. Markus Lenzhofer declares that he has no conflict of interest. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from all individual participants included in the study.