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.
ABSTRACT
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.
ABSTRACT
PURPOSE: Ophthalmic beta-blockers, used in the treatment of increased intraocular pressure, are known to cause pulmonary adverse effects. Few, if any, studies have quantified the extent of the problem in a real-life population. In this nationwide study, we assess the pulmonary safety of patients initiating treatment with ophthalmic beta-blockers. METHODS: Using the Danish Nationwide Registries from 1995 to 2012, we identified all individuals aged 20-90 years who initiated monotherapy with an intraocular pressure-lowering drug, with or without concomitant obstructive pulmonary disease. Risks of (i) switching to another drug and (ii) new onset of obstructive pulmonary disease during a 90-day follow-up were examined by cumulative risk and logistic regression models adjusted for available covariates. RESULTS: The cohort consisted of 97 463 individuals. Odds ratios for drug switch in individuals without concomitant obstructive pulmonary disease (n = 86 568) were as follows: 1.47 for beta-blockers (95% confidence interval (CI): 1.35-1.61; p < 0.001), 2.68 for parasympathomimetics (95% CI: 2.32-3.10; p < 0.001) and 4.80 for alfa-2-agonists (95% CI: 4.17-5.53; p < 0.001). Odds ratios in individuals with concomitant obstructive pulmonary disease (n = 10 895) were as follows: 2.61 for parasympathomimetics (95% CI: 1.83-3.72; p < 0.001), 2.96 for beta-blockers (95% CI: 2.31-3.78; p < 0.001) and 3.54 for alfa-2-agonists (95% CI: 2.56-4.88; p < 0.001). There was no significant association between treatment class and new onset of obstructive pulmonary disease (p = 0.30). CONCLUSION: Ophthalmic beta-blockers were associated with an increased risk of drug switch. However, the absolute risk was very small. No increased risk of new onset of obstructive pulmonary disease was found. Our data suggest that more patients might be eligible for ophthalmic beta-blockers.
