TY - JOUR
T1 - Expert Consensus on the Use of the PRESERFLO™ MicroShunt Device in the Treatment of Glaucoma
T2 - A Modified Delphi Panel
AU - Khawaja, Anthony P.
AU - Stalmans, Ingeborg
AU - Aptel, Florent
AU - Barton, Keith
AU - Beckers, Henny
AU - Klink, Thomas
AU - Marchini, Giorgio
AU - Martínez de la Casa, Jose
AU - Simonsen, Jan H.
AU - Töteberg-Harms, Marc
AU - Vass, Clemens
AU - Abegão Pinto, Luís
N1 - Funding Information:
This study was sponsored by Santen SA. The journal’s Rapid Service Fee and any other publication costs were funded by Santen SA. Anthony P. Khawaja is supported by a UK Research and Innovation Future Leaders Fellowship (MR/T040912/1).
Funding Information:
The authors acknowledge Massimiliano Malloni, Santen SA at the time of the study, and Claire Lea, Santen SA, for publication coordination. This study was sponsored by Santen SA. The journal’s Rapid Service Fee and any other publication costs were funded by Santen SA. Anthony P. Khawaja is supported by a UK Research and Innovation Future Leaders Fellowship (MR/T040912/1). The authors acknowledge Marielle Brown, PhD and Marc Lynch, PhD, from Costello Medical, UK, for medical writing and editorial assistance based on the authors’ input and direction. This was funded by Santen SA in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3 ). All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Substantial contributions to study conception and design: APK, IS, FA, KB, HB, TK, GM, JMC, JHS, MTH, CV, LAP; substantial contributions to analysis and interpretation of the data: APK, IS, FA, KB, HB, TK, GM, JMC, JHS, MTH, CV, LAP; drafting the article or revising it critically for important intellectual content: APK, IS, FA, KB, HB, TK, GM, JMC, JHS, MTH, CV, LAP; final approval of the version of the article to be published: APK, IS, FA, KB, HB, TK, GM, JMC, JHS, MTH, CV, LAP. Anthony P. Khawaja: Consultant: AbbVie, Aerie, Google Health, Novartis, Reichert, Santen, Théa. Ingeborg Stalmans: Consultant: Alcon, AbbVie, EyeD Pharma, MONA, Horus Pharma, Santen, Théa Pharma. Florent Aptel: Consultant: Alcon, Allergan, Eyetechcare, Glaukos, Horus, Novartis, Santen, Théa. Keith Barton: Consultant: Advanced Ophthalmic Innovations, Alcon, Allergan, Alimera Science, Carl Zeiss Meditec, C-Mer Holdings, ELTSight, EyeD Pharma, Glaukos, iStar, Ivantis, Kowa, Laboratoires Théa, PhPharma, Radiance Therapeutics, Santen Pharmaceutical Co. Ltd, Sight Sciences, Shifamed; Honorarium Recipient: Alcon, Allergan, Carl Zeiss Meditec., EyeTechCare, JamJoom Pharmaceuticals, Laboratoires Théa, Santen Pharmaceutical Co. Ltd; Stock Shareholder: Aquesys, International Glaucoma Surgery Registry Ltd., MedEther Ophthalmology (Hong Kong) Ltd, Vision Futures Ltd, Vision Medical Events Ltd; Patent: National University of Singapore. Henny Beckers: Consultant: Glaukos, Santen; Lecture fees: Glaukos, Novartis, Santen; Funding: Glaukos, InnFocus Inc., a Santen company, Nova Eye Medical. Thomas Klink: Consultant/Advisor: Allergan/AbbVie, Aerie, Santen; Lecture Fees: Allergan/AbbVie, Glaukos, Ivantis, Novartis, Santen. Giorgio Marchini: Consultant/Advisor: AbbVie, Alcon, Allergan, Dompé, GSK, Omikron, Santen. Jose Martínez de la Casa: Consultant: AJL, Alcon, Allergan, B&L, Glaukos, Novartis, Pfizer, Santen, Théa, Visufarma; Grants/research: Allergan, Glaukos, Ivantis, Pfizer, Santen, Théa; Speaker: Alcon, Allergan, B&L, Glaukos, ICare, Novartis, Pfizer, Santen, Théa. Jan H. Simonsen: Consultant: AbbVie, Santen; Lecture fees: AbbVie, Santen, Théa Pharma; Speaker and advisory board member for Santen. Marc Töteberg-Harms: Consultant/Advisor: Allergan/AbbVie, Eyelight, ELT Sight, IRIDEX, MLase AG, Reichert, Santen Inc.; Lecture fees: Allergan/AbbVie, Glaukos Corporation, Heidelberg Engineering, IRIDEX, MLase AG, Novartis/Alcon Pharmaceuticals, Reichert, Santen Inc., Théa Pharma; Research grants: IRIDEX, Santen Inc. Clemens Vass: Consultant: Allergan, iStar, Santen; Honorarium Recipient: Allergan, Carl Zeiss Meditec, Santen, Théa. Luis Abegão Pinto: Consultant: Allergan, Eyetechcare, NIDEK, Santen, Théa. This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. All data generated or analysed during this study are included in this published article/as supplementary information files.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/10
Y1 - 2022/10
N2 - Introduction: The implantation of the PRESERFLO™ MicroShunt (PMS) device has been shown to significantly lower increased intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). However, guidelines on best practice for patient selection and pre-/peri-/postoperative care management are lacking. The aim of this modified Delphi panel was to achieve expert consensus on the role of the PMS to treat patients with glaucoma in Europe. Methods: Twelve European glaucoma surgeons experienced with the PMS procedure participated in a three-round modified Delphi panel. A targeted literature review and expert steering committee guided round 1 questionnaire development. Consensus was set at a pre-defined threshold of at least 70% of panellists selecting ‘Strongly disagree’/‘Disagree’ or ‘Strongly agree’/‘Agree’ for six–point Likert scale questions, or at least 70% selecting the same option for multiple-choice questions. Questions not reaching consensus were restated/revised for the next round, following guidance from free-text responses/scoping questions. Results: Consensus was achieved for 60.3% (n = 38/63), 60.0% (n = 18/30), and 100.0% (n = 11/11) of Likert/multiple-choice questions in rounds 1, 2, and 3, respectively. There was agreement that the PMS procedure is effective at reducing IOP in patients with high-tension POAG (greater than 21 mmHg). Although surgical techniques may vary slightly, consensus was reached on several points, including the importance of posterior application of mitomycin C (MMC). Panellists agreed that the PMS postoperative follow-up appointment schedule is reasonably predictable and mostly characterised by fewer visits than with trabeculectomy, particularly in the early phase. Although panellists agreed that combined cataract/PMS surgery and the use of non-MMC wound-healing modulators/antifibrotics during the procedure are possible, further data are needed to determine efficacy. Conclusion: The expert consensus reached in this panel will help inform best practice guidelines in the treatment of patients with glaucoma in Europe. Panellists also highlighted key areas for future research to improve understanding of the PMS in the treatment algorithm of glaucoma.
AB - Introduction: The implantation of the PRESERFLO™ MicroShunt (PMS) device has been shown to significantly lower increased intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). However, guidelines on best practice for patient selection and pre-/peri-/postoperative care management are lacking. The aim of this modified Delphi panel was to achieve expert consensus on the role of the PMS to treat patients with glaucoma in Europe. Methods: Twelve European glaucoma surgeons experienced with the PMS procedure participated in a three-round modified Delphi panel. A targeted literature review and expert steering committee guided round 1 questionnaire development. Consensus was set at a pre-defined threshold of at least 70% of panellists selecting ‘Strongly disagree’/‘Disagree’ or ‘Strongly agree’/‘Agree’ for six–point Likert scale questions, or at least 70% selecting the same option for multiple-choice questions. Questions not reaching consensus were restated/revised for the next round, following guidance from free-text responses/scoping questions. Results: Consensus was achieved for 60.3% (n = 38/63), 60.0% (n = 18/30), and 100.0% (n = 11/11) of Likert/multiple-choice questions in rounds 1, 2, and 3, respectively. There was agreement that the PMS procedure is effective at reducing IOP in patients with high-tension POAG (greater than 21 mmHg). Although surgical techniques may vary slightly, consensus was reached on several points, including the importance of posterior application of mitomycin C (MMC). Panellists agreed that the PMS postoperative follow-up appointment schedule is reasonably predictable and mostly characterised by fewer visits than with trabeculectomy, particularly in the early phase. Although panellists agreed that combined cataract/PMS surgery and the use of non-MMC wound-healing modulators/antifibrotics during the procedure are possible, further data are needed to determine efficacy. Conclusion: The expert consensus reached in this panel will help inform best practice guidelines in the treatment of patients with glaucoma in Europe. Panellists also highlighted key areas for future research to improve understanding of the PMS in the treatment algorithm of glaucoma.
KW - Consensus
KW - Delphi method
KW - Europe
KW - Glaucoma
KW - MicroShunt
KW - Open-angle glaucoma
KW - PRESERFLO™
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U2 - 10.1007/s40123-022-00529-4
DO - 10.1007/s40123-022-00529-4
M3 - Article
AN - SCOPUS:85133590291
SN - 2193-8245
VL - 11
SP - 1743
EP - 1766
JO - Ophthalmology and Therapy
JF - Ophthalmology and Therapy
IS - 5
ER -