PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety.
Jamke Melanie, Herber Robert, Haase Maike A, Jasper Carolin S, Pillunat Lutz E, Pillunat Karin R
AI Summary
This study found PRESERFLO MicroShunt and trabeculectomy equally effective in lowering IOP for POAG after one year, but trabeculectomy required more interventions, suggesting MicroShunt may offer a less burdensome option.
Abstract
Purpose
To compare the efficacy and safety of the PRESERFLO™ MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG) after one year.
Patients and methods: Institutional prospective interventional cohort study comparing eyes with POAG, which had received the PRESERFLO™ MicroShunt versus trabeculectomy. The MicroShunt group was matched with the trabeculectomy group for age, known duration of disease, and number and classes of intraocular pressure (IOP) lowering medications to have similar conjunctival conditions. The study is part of the Dresden Glaucoma and Treatment Study, using a uniform study design, with the same inclusion and exclusion criteria, follow-ups and standardized definitions of success and failure for both procedures.
Primary outcome measures: mean diurnal IOP (mdIOP, mean of 6 measurements), peak IOP, and IOP fluctuations.
Secondary outcome measures: success rates, number of IOP lowering medications, visual acuity, visual fields, complications, surgical interventions, and adverse events.
Results
Sixty eyes of 60 patients, 30 in each group, were analyzed after 1-year follow-ups. Median [Q25, Q75] mdIOP (mmHg) dropped from 16.2 [13.8-21.5] to 10.5 [8.9-13.5] in the MicroShunt and from 17.6 [15.6-24.0] to 11.1 [9.5-12.3] in the trabeculectomy group, both without glaucoma medications. Reduction of mdIOP (P = .596), peak IOP (P = .702), and IOP fluctuations (P = .528) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy group, especially in the early postoperative period (P = .018). None of the patients experienced severe adverse events.
Conclusion
Both procedures are equally effective and safe in lowering mdIOP, peak IOP and IOP fluctuations in patients with POAG, one year after surgery.
Clinical trial registration: NCT02959242.
MeSH Terms
Shields Classification
Key Concepts5
The median diurnal intraocular pressure (mdIOP) in patients with primary open-angle glaucoma (POAG) who received the PRESERFLO™ MicroShunt dropped from 16.2 [13.8-21.5] mmHg to 10.5 [8.9-13.5] mmHg after one year, without glaucoma medications.
The median diurnal intraocular pressure (mdIOP) in patients with primary open-angle glaucoma (POAG) who underwent trabeculectomy dropped from 17.6 [15.6-24.0] mmHg to 11.1 [9.5-12.3] mmHg after one year, without glaucoma medications.
The reduction of mean diurnal IOP (P = .596), peak IOP (P = .702), and IOP fluctuations (P = .528) was not statistically significantly different between patients with primary open-angle glaucoma (POAG) treated with PRESERFLO™ MicroShunt versus trabeculectomy after one year.
The rate of interventions was statistically significantly higher in the trabeculectomy group compared to the PRESERFLO™ MicroShunt group in patients with primary open-angle glaucoma (POAG), especially in the early postoperative period (P = .018).
None of the 60 patients with primary open-angle glaucoma (POAG) experienced severe adverse events after treatment with either PRESERFLO™ MicroShunt or trabeculectomy at one year.
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