Khawaja Anthony P, Stalmans Ingeborg, Aptel Florent, Barton Keith, Beckers Henny, Klink Thomas, Marchini Giorgio, Martínez de la Casa Jose, Simonsen Jan H, Töteberg-Harms Marc, Vass Clemens, Abegão Pinto Luís
NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK.
Department of Ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium.
Ophthalmol Ther. 2022 Oct;11(5):1743-1766. doi: 10.1007/s40123-022-00529-4. Epub 2022 Jul 7.
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.
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.
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.
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.
已证明植入 PRESERFLO™ 微分流器（PMS）可显著降低原发性开角型青光眼（POAG）患者升高的眼压（IOP）。然而，目前缺乏关于患者选择以及术前/术中/术后护理管理最佳实践的指南。本次改良德尔菲小组的目的是就 PMS 在欧洲治疗青光眼患者中的作用达成专家共识。
12 位有 PMS 手术经验的欧洲青光眼外科医生参与了三轮改良德尔菲小组。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。对于六点李克特量表问题，当至少 70%的小组成员选择“强烈反对”/“反对”或“强烈同意”/“同意”时，或对于多项选择题，当至少 70%的成员选择同一选项时，达成共识。未达成共识的问题根据自由文本回复/范围界定问题的指导在下一轮中重新表述/修订。
在第一轮、第二轮和第三轮中，李克特/多项选择题分别有 60.3%（n = 38/63）、60.0%（n = 18/30）和 100.0%（n = 11/11）达成了共识。大家一致认为，PMS 手术对于降低高眼压性 POAG（眼压大于 21 mmHg）患者的眼压是有效的。尽管手术技术可能略有不同，但在几个方面达成了共识，包括术中应用丝裂霉素 C（MMC）的重要性。小组成员一致认为，PMS 术后随访预约时间表具有合理的可预测性，而且与小梁切除术相比，随访次数较少，尤其是在早期。尽管小组成员一致认为可以进行白内障/PMS 联合手术以及在手术过程中使用非 MMC 伤口愈合调节剂/抗纤维化药物，但需要更多数据来确定其疗效。
本小组达成的专家共识将有助于为欧洲青光眼患者治疗的最佳实践指南提供参考。小组成员还强调了未来研究的关键领域，以增进对 PMS 在青光眼治疗算法中的理解。
