Khawaja Anthony P, Abegão Pinto Luís, Stalmans Ingeborg, Aptel Florent, Barkander Anna, Barton Keith, Beckers Henny, Iliev Milko, Klink Thomas, Marchini Giorgio, Martínez de la Casa Jose, Pillunat Karin R, Simonsen Jan H, Vass Clemens
NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
Department of Ophthalmology, Hospital Santa Maria, Lisbon, Portugal.
Ophthalmol Ther. 2024 Jun;13(6):1569-1588. doi: 10.1007/s40123-024-00902-5. Epub 2024 Apr 8.
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.
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.
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.
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.
PRESERFLO™ 微分流器（PMS）已被证明能显著降低青光眼患者的眼压，自2019年起可供使用。随着越来越多已发表的证据以及青光眼外科医生经验的增加，本次改良德尔菲专家小组的目的是在2021年进行的前一次德尔菲专家小组的研究结果基础上，就PMS在欧洲治疗青光眼患者中的作用提供进一步指导。
13名有PMS手术经验的欧洲青光眼外科医生参与了一轮3轮的改良德尔菲专家小组。有针对性的文献综述和专家指导委员会指导了第一轮问卷的制定。对于6点李克特量表问题，当≥70%的小组成员选择“强烈同意”/“同意”或“强烈不同意”/“不同意”，或者对于多项或单项选择题，≥70%的成员选择相同选项时，预定义达成共识。未达成共识的问题会根据自由文本回复/范围界定问题的指导在下一轮中重新表述/修订。
在第1轮、第2轮和第3轮中，分别有28%（n = 9/32）、52%（n = 16/31）和91%（n = 10/11）的陈述达成了共识。大家一致认为，PMS可用于色素性、创伤后或玻璃体切除术后青光眼患者以及无活动性炎症的葡萄膜炎性青光眼患者。与其他结膜下滤过手术相比，PMS可能更适合佩戴隐形眼镜的患者，但并不能消除与滤过泡相关的风险。达成的共识是，将PMS植入与超声乳化术相结合可能与单独的PMS手术一样安全，但需要更多的疗效数据。术后≥4个月眼压出现后期升高时，局部使用降眼压滴眼液或对滤过泡进行修复可能是合适的处理选择。
本次德尔菲专家小组以2021年德尔菲专家小组探讨的考虑因素为基础，为青光眼外科医生提供了关于PMS使用的进一步详细指导，反映了新证据的可得性和手术经验。本文配有视频。
