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. 2023 Oct;261(10):2901-2915.
doi: 10.1007/s00417-023-06075-4. Epub 2023 May 3.

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety

Melanie Jamke  1 , Robert Herber  1 , Maike A Haase  1 , Carolin S Jasper  1 , Lutz E Pillunat  1 , Karin R Pillunat  2
Affiliations

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety

Melanie Jamke et al. Graefes Arch Clin Exp Ophthalmol. 2023 Oct.

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.

Keywords: 24-h IOP; Diurnal IOP fluctuation; Mean diurnal IOP; MicroShunt; Open-angle glaucoma; PRESERFLO™ MicroShunt; Peak diurnal IOP; Trabeculectomy.

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Conflict of interest statement

None of the authors has any financial interest or any conflict of interest related to the subject matter.

Figures

Fig. 1
Fig. 1
Boxplots showing mean diurnal intraocular pressure (mdIOP) at baseline and at the 12-month follow-up in the MicroShunt and trabeculectomy group. * Statistical significance (P < 0.05, Wilcoxon test)
Fig. 2
Fig. 2
Graph showing the median diurnal intraocular pressure (IOP) at the different measurement times at baseline and at 12 months in the MicroShunt and trabeculectomy group. CI, confidence interval
Fig. 3
Fig. 3
a) Scatterplot showing mean diurnal intraocular pressure (mdIOP) reductions at 12 months ≤ 18 and ≤ 14 mmHg as well as ≤ 20% in the MicroShunt group. b) Scatterplot showing mean diurnal intraocular pressure (mdIOP) reductions at 12 months ≤ 18 and ≤ 14 mmHg as well as ≤ 20% in the trabeculectomy group
Fig. 4
Fig. 4
a) Scatterplot showing mean diurnal peak intraocular pressure reductions at 12 months ≤ 18 as well as ≤ 20% in the MicroShunt group. b) Scatterplot showing mean diurnal peak intraocular pressure reductions at 12 months ≤ 18 as well as ≤ 20% in the trabeculectomy group
Fig. 5
Fig. 5
Comparison of the rate of complete success according to the definitions of the study by Baker et al. [2] which is a ≥ 20% IOP reduction from baseline at 1 year without increasing the number of glaucoma medications between the current study and the study by Baker et al. PMS = PRESERFLO MicroShunt; TE = trabeculectomy
See this image and copyright information in PMC

References

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