PRESERFLO™ MicroShunt versus trabeculectomy: first results on efficacy and safety

• Published in: Acta ophthalmologica (Oxford, England) England), 2022-05, Vol.100 (3), p.e779-e790
• Main Authors: Pillunat, Karin R., Herber, Robert, Haase, Maike A., Jamke, Melanie, Jasper, Carolin S., Pillunat, Lutz E.
• Format: Article
• Language: English
• Subjects: Acuity; Adverse events; Cohort Studies; Diurnal; Glaucoma; Glaucoma - surgery; Glaucoma, Open-Angle - drug therapy; Glaucoma, Open-Angle - surgery; Humans; Intraocular Pressure; IOP fluctuation; mean diurnal IOP reduction; open‐angle glaucoma; Patients; peak IOP; PRESERFLO™ MicroShunt; Prospective Studies; Retrospective Studies; trabeculectomy; Trabeculectomy - methods; Treatment Outcome
• ISSN: 1755-375X; 1755-3768
• DOI: 10.1111/aos.14968

Purpose To report efficacy and safety outcomes of the PRESERFLO™ MicroShunt compared with trabeculectomy, the current gold‐standard treatment for advanced glaucoma, in the early and intermediate postoperative period. Methods Institutional prospective interventional cohort study of primary open‐angle glaucoma (POAG) patients scheduled for the PRESERFLO™ MicroShunt. The comparison group were POAG patients who had had received trabeculectomy and were matched for age, known duration of disease, number and classes of intraocular pressure (IOP)‐lowering medications to ensure a similar conjunctival condition. The study is part of the Dresden Glaucoma and Treatment Study (DGTS), was not randomized, but used a uniform study design, with the same inclusion and exclusion criteria as well as standardized definitions of success and failure. Main outcome measures: mean diurnal IOP (mdIOP, mean of 6 measurements), diurnal peak IOP, diurnal IOP fluctuations, glaucoma medical therapy, success rates, visual acuity, visual fields, surgical complications and interventions, and severe adverse events. Results Fifty‐two eyes of 52 patients, 26 in each group, were analysed. At 6 months, median [Q25, Q75] mdIOP was 10.8 [9.5–12.2] mmHg in the microshunt and 10.3 [7.6–11.8] mmHg in the trabeculectomy group. Reduction in mdIOP (p = 0.458), peak diurnal IOP (p = 0.539), and median diurnal fluctuation (p = 0.693) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy compared with the microshunt group (p = 0.004). None of the patients experienced severe adverse events. Conclusion Both procedures are equally effective and safe in lowering mdIOP in patients with POAG. Because the microshunt is less invasive with less follow‐up and interventions needed postoperatively, it might be recommended earlier in the treatment of glaucoma.