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. 2025 Feb 1;34(2):103-113.
doi: 10.1097/IJG.0000000000002509. Epub 2024 Oct 11.

Early Results of Preserflo MicroShunt for Primary Open Angle Glaucoma in White Patients

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

Early Results of Preserflo MicroShunt for Primary Open Angle Glaucoma in White Patients

Karin R Pillunat et al. J Glaucoma. .

Abstract

Prcis: The Preserflo MicroShunt effectively lowered intraocular pressure in primary high and normal pressure open angle glaucoma.

Purpose: To evaluate the efficacy and safety of the Preserflo MicroShunt in patients with primary open angle glaucoma (POAG) and the 2 variants high (HPG) and normal pressure glaucoma (NPG) after 1 year.

Methods: Single-center prospective interventional case series consecutively including eyes of White/European patients with POAG, who received the Preserflo MicroShunt as a primary and standalone glaucoma intervention. Primary outcome measures: change in mean 24-hour IOP (mdIOP, mean of 6 measurements), peak IOP, IOP fluctuations, antiglaucoma medications, and success rates. Secondary outcome measures include visual acuity, visual fields, complications, surgical interventions, and adverse events.

Results: Forty-two eyes of 42 patients with POAG, 29 in the HPG and 13 in the NPG group, were analyzed after 1-year follow-ups. Median [Q25, Q75] medicated mdIOP (mm Hg) dropped by 30% from 16.5 [13.7-27.3] to 12.8 [10.2-14.5] in the HPG and by 40% from 14.3 [13.3-16.0] to 9.5 [8.3-11.1] in the NPG group, with a median postoperative medication use of 0 [0-0] in both groups. At 1 year, 92.5% of eyes were medication-free versus 0% preoperatively. The reduction of mdIOP ( P =1.0), peak IOP ( P =0.932), IOP fluctuations ( P =0.142), and the rate of interventions ( P =0.298) were not statistically significantly different between the HPG and NPG group. None of the patients experienced severe adverse events or loss of vision.

Conclusions: Effective and safe intraocular pressure lowering was observed 1 year following MicroShunt implantation for primary HPG and NPG in White patients of European descent.

Trial registration: ClinicalTrials.gov NCT02959242.

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Conflict of interest statement

Disclosure: K.R.P. has received lecture fees from Allergan, Santen, and Novartis. L.E.P. has received lecture fees from Allergan and Santen and is on the Advisory Board for Allergan, Santen, and Aerie, and received grant support from Novartis. The other authors declare no conflict of interest.

References

    1. Heijl A, Leske MC, Bengtsson B, et al. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120:1268–1279.
    1. CNTGS. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998;126:487–497.
    1. Leske MC, Hyman L, Hussein M, et al. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Am J Ophthalmol. 1999;127:625–626.
    1. Pillunat KR, Herber R, Haase MA, et al. PRESERFLO MicroShunt versus trabeculectomy: first results on efficacy and safety. Acta Ophthalmol. 2022;100:e779–e790.
    1. Jamke M, Herber R, Haase MA, et al. MicroShunt versus trabeculectomy: 1-year results on efficacy and safety. Graefes Arch Clin Exp Ophthalmol. 2023;261:2901–2915.

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