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. 2024 Jun;13(6):1569-1588.
doi: 10.1007/s40123-024-00902-5. Epub 2024 Apr 8.

Additional Guidance on the Use of the PRESERFLO™ MicroShunt in the Treatment of Glaucoma: Insights from a Second Delphi Consensus Panel

Anthony P Khawaja  1 , Luís Abegão Pinto  2 , Ingeborg Stalmans  3   4 , Florent Aptel  5 , Anna Barkander  6 , Keith Barton  7 , Henny Beckers  8 , Milko Iliev  9 , Thomas Klink  10 , Giorgio Marchini  11 , Jose Martínez de la Casa  12 , Karin R Pillunat  13 , Jan H Simonsen  14 , Clemens Vass  15
Affiliations

Additional Guidance on the Use of the PRESERFLO™ MicroShunt in the Treatment of Glaucoma: Insights from a Second Delphi Consensus Panel

Anthony P Khawaja et al. Ophthalmol Ther. 2024 Jun.

Abstract

Introduction: The PRESERFLO™ MicroShunt (PMS) has been proven to significantly lower intraocular pressure (IOP) in patients with glaucoma and has been available for use since 2019. With increasing published evidence and growing experience of glaucoma surgeons, the aim of this modified Delphi panel was to build on the findings of a previous Delphi panel conducted in 2021 and provide further guidance on the role of the PMS to treat patients with glaucoma in Europe.

Methods: Thirteen European glaucoma surgeons experienced in the PMS procedure participated in a 3-round modified Delphi panel. A targeted literature review and expert steering committee guided Round 1 questionnaire development. Consensus was pre-defined at a threshold of ≥ 70% of panellists selecting 'strongly agree'/'agree' or 'strongly disagree'/'disagree' for 6-point Likert scale questions or ≥ 70% selecting the same option for multiple or single-choice questions. Questions not reaching consensus were restated/revised for the next round, following guidance from free-text responses/scoping questions.

Results: In total, 28% (n = 9/32), 52% (n = 16/31) and 91% (n = 10/11) of statements reached consensus in Rounds 1, 2 and 3, respectively. There was agreement that the PMS may be used in patients with pigmentary, post-trauma or post-vitrectomy glaucoma and for patients with uveitic glaucoma without active inflammation. The PMS may be more suitable for patients with contact lenses than other subconjunctival filtering surgeries, without eliminating bleb-associated risks. Consensus was reached that combining PMS implantation and phacoemulsification may be as safe as standalone PMS surgery, but further efficacy data are required. Following a late rise in IOP ≥ 4 months post-surgery, topical aqueous suppressant drops or bleb revision may be suitable management options.

Conclusions: This Delphi panel builds on the considerations explored in the 2021 Delphi panel and provides further detailed guidance for glaucoma surgeons on the use of the PMS, reflecting the availability of novel evidence and surgical experience. Videos are available for this article.

Keywords: Consensus; Glaucoma; Glaucoma surgery; Intraocular pressure; MIGS; MicroShunt; PRESERFLO™.

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Conflict of interest statement

Anthony P. Khawaja: Consultant: AbbVie, Aerie, Google Health, Novartis, Reichert, Santen, Théa; Luís Abegão Pinto: Consultant: Allergan, Eyetechcare, NIDEK, Santen, Théa; Ingeborg Stalmans: Cofounder and Shareholder: MONA; Consultant: Alcon, Allergan/AbbVie, Bausch & Lomb, Elios Vision, EyeD Pharma, MONA, Horus Pharma, Omikron Pharma, Santen, Théa Pharma; Florent Aptel: Consultant: Alcon, Allergan, Eyetechcare, Glaukos, Horus, Novartis, Santen, Théa; Anna Barkander: Advisory board member for Santen and iStar; Lecture fees: New World Medical; 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, Elios; Lecture fees: Glaukos, Novartis, Santen; Funding: Glaukos, InnFocus Inc., a Santen company, Nova Eye Medical; Milko Iliev: Consultant/Advisor: Théa, Allergan/AbbVie, Santen, iStar; Lecture Fees Thomas Klink: Consultant/Advisor: Allergan/AbbVie, Aerie, Santen; Lecture Fees: Alcon, Allergan/AbbVie, Glaukos, Ivantis, Novartis, Santen; Giorgio Marchini: Consultant/Advisor: AbbVie, Alcon, Allergan, Dompé, GSK, Omikron, Santen; Jose Martínez de la Casa: Consultant: Alcon, AbbVie, B&L, Glaukos, Viatris, Santen, Théa, Visufarma; Grants/research: AbbVie, Glaukos, Viatris, Santen, Théa; Speaker: Alcon, AbbVie, B&L, Glaukos, ICare, Viatris, Santen, Théa; Karin R. Pillunat: Lecture fees: Allergan/AbbVie, Santen, Novartis, Théa; Jan H. Simonsen: Consultant: AbbVie, Santen; Lecture fees: AbbVie, Santen; Speaker and advisory board member for Santen; Clemens Vass: Consultant: Allergan, iStar, Santen; Honorarium Recipient: Allergan, Carl Zeiss Meditec, Santen, Théa.

Figures

Fig. 1
Fig. 1
Delphi panel study design. aThe number of questions which could have possibly reached consensus in Round 1, excluding scoping questions. bConsensus threshold: ≥ 70% agreement or ≥ 70% disagreement for Likert statements and ≥ 70% of participants selecting the same answer for single-choice, yes-no or multiple-choice questions. SC steering committee
Fig. 2
Fig. 2
Summary of consensus on key aspects on treating patients with glaucoma with the PMS. aAlthough suitability will be influenced by bleb morphology and require postoperative reassessment. In addition, as with all subconjunctival surgeries, there are risks associated with wearing contact lenses postoperatively. IOP intraocular pressure, PMS PRESERFLO™ MicroShunt, POAG primary open-angle glaucoma
Fig. 3
Fig. 3
Diagram to show the blue/white (sclera) transition zone for use with the scleral marker
See this image and copyright information in PMC

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