Supraciliary micro-stent implantation for open-angle glaucoma failing topical therapy: 1-year results of a multicenter study

Julian García-Feijoo; Magda Rau; Swaantje Grisanti; Salvatore Grisanti; Helmut Höh; Carl Erb; Pravoslava Guguchkova; Iqbal Ahmed; Günther Grabner; Herbert Reitsamer; Tarek Shaarawy; Tsontcho Ianchulev

doi:10.1016/j.ajo.2015.02.018

Supraciliary micro-stent implantation for open-angle glaucoma failing topical therapy: 1-year results of a multicenter study

Julian García-Feijoo, Magda Rau, Swaantje Grisanti, Salvatore Grisanti, Helmut Höh, Carl Erb, Pravoslava Guguchkova, Iqbal Ahmed, Günther Grabner, Herbert Reitsamer, Tarek Shaarawy, Tsontcho Ianchulev

Research output: Contribution to journal › Article › peer-review

78 Scopus citations

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.

Original language	English
Pages (from-to)	1075-1081.e1
Journal	American Journal of Ophthalmology
Volume	159
Issue number	6
DOIs	https://doi.org/10.1016/j.ajo.2015.02.018
State	Published - 1 Jun 2015
Externally published	Yes

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10.1016/j.ajo.2015.02.018

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García-Feijoo, J., Rau, M., Grisanti, S., Grisanti, S., Höh, H., Erb, C., Guguchkova, P., Ahmed, I., Grabner, G., Reitsamer, H., Shaarawy, T., & Ianchulev, T. (2015). Supraciliary micro-stent implantation for open-angle glaucoma failing topical therapy: 1-year results of a multicenter study. American Journal of Ophthalmology, 159(6), 1075-1081.e1. https://doi.org/10.1016/j.ajo.2015.02.018

@article{2bc63ab77a80413cb9b39501c5b2e789,

title = "Supraciliary micro-stent implantation for open-angle glaucoma failing topical therapy: 1-year results of a multicenter study",

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.",

author = "Julian Garc{\'i}a-Feijoo and Magda Rau and Swaantje Grisanti and Salvatore Grisanti and Helmut H{\"o}h and Carl Erb and Pravoslava Guguchkova and Iqbal Ahmed and G{\"u}nther Grabner and Herbert Reitsamer and Tarek Shaarawy and Tsontcho Ianchulev",

note = "Funding Information: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Julian Garc{\'i}a-Feijo{\'o} received a consulting fee from Transcend Medical, Inc, Menlo Park, California and his institution received a grant from Transcend Medical, Inc for participation in this study. He has also received consulting fees from Glaukos Corporation, Laguna Hills, California; Ivantis, Inc, Irvine, California; Alcon, Inc, H{\"u}nenberg, Switzerland; Merck & Co, Inc, Whitehouse Station, New Jersey; Bausch & Lomb, Rochester, New York; and Sensimed SA, Lausanne, Switzerland; grants from Glaukos Corporation; Ivantis, Inc; Alcon, Inc; Merck & Co, Inc; Bausch & Lomb; Sensimed SA; Sylentis SA, Madrid, Spain; Pfizer, Inc, New York, New York; Allergan, Inc, Irvine, California; Laboratoires Th{\'e}a, Clermont-Ferrand, France; and SOLX, Inc, Waltham, Massachusetts; and speaker fees from Alcon, Inc; Merck & Co, Inc; and Abbott Medical Optics, Inc, Milpitas, California. Magda Rau has received consulting fees from Transcend Medical, Inc, and her institution has received fees for clinical advisory services and clinical research from Transcend Medical, Inc and other companies. Helmut H{\"o}h's institution received research grants from Transcend Medical, Inc for the DUETTE study and other clinical trials. He has also received research grants from Glaukos Corporation; AqueSys Inc, Aliso Viejo, California; Novartis AG, Basel, Switzerland; Hoya Corporation, Tokyo, Japan; Oculentis BV, Eerbeek, Netherlands; Afidera GmbH, Berlin, Germany; and Bayer AG, Leverkusen, Germany. Carl Erb received reimbursement from Transcend Medical, Inc for study-related travel. Pravoslava Guguchkova received a consulting fee from Transcend Medical, Inc, and her institution has received clinical research funds from other companies. Iqbal Ahmed has received consulting fees (C), speakers honoraria (S), or research grant support (R) from Transcend Medical, Inc (C,R); Abbott Medical Optics, Inc (C,S,R); AdeTherapeutics, Inc, Sakatoon, Saskatchewan, Canada (C); ACE Vision Group, Inc, Silver Lake, Ohio (C); Alcon, Inc (C,S,R); Allergan, Inc (C,S,R); Aquesys, Inc (C,R); Carl Zeiss Meditec AG, Jena, Germany (C,S,R); Clarity Medical Systems, Inc, Pleasanton, California (C,S); Endo Optiks, Inc, Little Silver, New Jersey (C); ForSight Labs, LLC, Menlo Park, California (C); Glaukos Corporation (C,R); InnFocus, Inc, Miami, Florida (C); Iridex Corporation, Mountain View, California (C); Ivantis, Inc (C,R); Liquidia Technologies, Inc, Research Triangle Park, North Carolina (C); Mastel Precision Surgical Instruments, Inc, Rapid City, South Dakota (S); MicroSurgical Technology, Inc, Redmond, Washington (S); Neomedix Corporation, Tustin, California (S); New World Medical, Inc, Rancho Cucamonga, California (R); Ono Pharmaceutical Co, Ltd, Osaka, Japan (C); Santen Pharmaceutical Co, Ltd, Osaka, Japan (C); Sensimed SA (C); SOLX, Inc (C,R); Strōma Medical Corporation, Laguna Beach, California (C); and TrueVision Systems, Inc, Santa Barbara, California (C). Herbert Reitsamer's institution received a grant from Salzburg State Clinic (SALK) for the DUETTE study, and he has received consulting fees from Transcend Medical, Inc; AqueSys, Inc; Aliophtha AG, Binningen Switzerland; and Novartis AG. Tsontcho Ianchulev is an employee of Transcend Medical, Inc in the role of Chief Medical Officer, for which he receives salary; other financial interests for TI are Wavetec Inc (inventor/advisor/equityholder); SafeOp Surgical, Inc, Stamford, Connecticut (board member); Kurobe Pharmaceuticals Inc, Tampa, Florida (board member); Tullis Health Investors, Greenwich, Connecticut (venture partner); PME Ventures, San Francisco, California (partner); and ForSight Vision5, Menlo Park, California (clinical advisor). This study and preparation of this article was sponsored and funded by Transcend Medical, Inc . All authors attest that they meet the current ICMJE requirements to qualify as authors. Publisher Copyright: {\textcopyright} 2015 Elsevier Inc.",

year = "2015",

month = jun,

day = "1",

doi = "10.1016/j.ajo.2015.02.018",

language = "English",

volume = "159",

pages = "1075--1081.e1",

journal = "American Journal of Ophthalmology",

issn = "0002-9394",

publisher = "Elsevier USA",

number = "6",

}

García-Feijoo, J, Rau, M, Grisanti, S, Grisanti, S, Höh, H, Erb, C, Guguchkova, P, Ahmed, I, Grabner, G, Reitsamer, H, Shaarawy, T & Ianchulev, T 2015, 'Supraciliary micro-stent implantation for open-angle glaucoma failing topical therapy: 1-year results of a multicenter study', American Journal of Ophthalmology, vol. 159, no. 6, pp. 1075-1081.e1. https://doi.org/10.1016/j.ajo.2015.02.018

TY - JOUR

T1 - Supraciliary micro-stent implantation for open-angle glaucoma failing topical therapy

T2 - 1-year results of a multicenter study

AU - García-Feijoo, Julian

AU - Rau, Magda

AU - Grisanti, Swaantje

AU - Grisanti, Salvatore

AU - Höh, Helmut

AU - Erb, Carl

AU - Guguchkova, Pravoslava

AU - Ahmed, Iqbal

AU - Grabner, Günther

AU - Reitsamer, Herbert

AU - Shaarawy, Tarek

AU - Ianchulev, Tsontcho

N1 - Funding Information: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Julian García-Feijoó received a consulting fee from Transcend Medical, Inc, Menlo Park, California and his institution received a grant from Transcend Medical, Inc for participation in this study. He has also received consulting fees from Glaukos Corporation, Laguna Hills, California; Ivantis, Inc, Irvine, California; Alcon, Inc, Hünenberg, Switzerland; Merck & Co, Inc, Whitehouse Station, New Jersey; Bausch & Lomb, Rochester, New York; and Sensimed SA, Lausanne, Switzerland; grants from Glaukos Corporation; Ivantis, Inc; Alcon, Inc; Merck & Co, Inc; Bausch & Lomb; Sensimed SA; Sylentis SA, Madrid, Spain; Pfizer, Inc, New York, New York; Allergan, Inc, Irvine, California; Laboratoires Théa, Clermont-Ferrand, France; and SOLX, Inc, Waltham, Massachusetts; and speaker fees from Alcon, Inc; Merck & Co, Inc; and Abbott Medical Optics, Inc, Milpitas, California. Magda Rau has received consulting fees from Transcend Medical, Inc, and her institution has received fees for clinical advisory services and clinical research from Transcend Medical, Inc and other companies. Helmut Höh's institution received research grants from Transcend Medical, Inc for the DUETTE study and other clinical trials. He has also received research grants from Glaukos Corporation; AqueSys Inc, Aliso Viejo, California; Novartis AG, Basel, Switzerland; Hoya Corporation, Tokyo, Japan; Oculentis BV, Eerbeek, Netherlands; Afidera GmbH, Berlin, Germany; and Bayer AG, Leverkusen, Germany. Carl Erb received reimbursement from Transcend Medical, Inc for study-related travel. Pravoslava Guguchkova received a consulting fee from Transcend Medical, Inc, and her institution has received clinical research funds from other companies. Iqbal Ahmed has received consulting fees (C), speakers honoraria (S), or research grant support (R) from Transcend Medical, Inc (C,R); Abbott Medical Optics, Inc (C,S,R); AdeTherapeutics, Inc, Sakatoon, Saskatchewan, Canada (C); ACE Vision Group, Inc, Silver Lake, Ohio (C); Alcon, Inc (C,S,R); Allergan, Inc (C,S,R); Aquesys, Inc (C,R); Carl Zeiss Meditec AG, Jena, Germany (C,S,R); Clarity Medical Systems, Inc, Pleasanton, California (C,S); Endo Optiks, Inc, Little Silver, New Jersey (C); ForSight Labs, LLC, Menlo Park, California (C); Glaukos Corporation (C,R); InnFocus, Inc, Miami, Florida (C); Iridex Corporation, Mountain View, California (C); Ivantis, Inc (C,R); Liquidia Technologies, Inc, Research Triangle Park, North Carolina (C); Mastel Precision Surgical Instruments, Inc, Rapid City, South Dakota (S); MicroSurgical Technology, Inc, Redmond, Washington (S); Neomedix Corporation, Tustin, California (S); New World Medical, Inc, Rancho Cucamonga, California (R); Ono Pharmaceutical Co, Ltd, Osaka, Japan (C); Santen Pharmaceutical Co, Ltd, Osaka, Japan (C); Sensimed SA (C); SOLX, Inc (C,R); Strōma Medical Corporation, Laguna Beach, California (C); and TrueVision Systems, Inc, Santa Barbara, California (C). Herbert Reitsamer's institution received a grant from Salzburg State Clinic (SALK) for the DUETTE study, and he has received consulting fees from Transcend Medical, Inc; AqueSys, Inc; Aliophtha AG, Binningen Switzerland; and Novartis AG. Tsontcho Ianchulev is an employee of Transcend Medical, Inc in the role of Chief Medical Officer, for which he receives salary; other financial interests for TI are Wavetec Inc (inventor/advisor/equityholder); SafeOp Surgical, Inc, Stamford, Connecticut (board member); Kurobe Pharmaceuticals Inc, Tampa, Florida (board member); Tullis Health Investors, Greenwich, Connecticut (venture partner); PME Ventures, San Francisco, California (partner); and ForSight Vision5, Menlo Park, California (clinical advisor). This study and preparation of this article was sponsored and funded by Transcend Medical, Inc . All authors attest that they meet the current ICMJE requirements to qualify as authors. Publisher Copyright: © 2015 Elsevier Inc.

PY - 2015/6/1

Y1 - 2015/6/1

N2 - 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.

AB - 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.

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U2 - 10.1016/j.ajo.2015.02.018

DO - 10.1016/j.ajo.2015.02.018

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C2 - 25747677

AN - SCOPUS:84929131899

SN - 0002-9394

VL - 159

SP - 1075-1081.e1

JO - American Journal of Ophthalmology

JF - American Journal of Ophthalmology

IS - 6

ER -

Supraciliary micro-stent implantation for open-angle glaucoma failing topical therapy: 1-year results of a multicenter study

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