Early Results of Preserflo MicroShunt for Primary Open Angle Glaucoma in White Patients.
Pillunat Karin R, Herber Robert, Jamke Melanie, Jasper Carolin S, Haase Maike A, Manseck Anna S, Pillunat Lutz E
AI Summary
The Preserflo MicroShunt effectively lowered intraocular pressure and medication use in White patients with high and normal pressure open-angle glaucoma, demonstrating its safety and efficacy for both variants.
Abstract
Précis: 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.
MeSH Terms
Shields Classification
Key Concepts6
The Preserflo MicroShunt effectively lowered intraocular pressure in primary high pressure glaucoma (HPG) and normal pressure glaucoma (NPG) in White patients of European descent.
In White patients with primary open angle glaucoma (POAG), the median medicated mean 24-hour IOP (mdIOP) dropped by 30% from 16.5 [13.7-27.3] to 12.8 [10.2-14.5] mm Hg in the high pressure glaucoma (HPG) group after 1 year following Preserflo MicroShunt implantation.
In White patients with primary open angle glaucoma (POAG), the median medicated mean 24-hour IOP (mdIOP) dropped by 40% from 14.3 [13.3-16.0] to 9.5 [8.3-11.1] mm Hg in the normal pressure glaucoma (NPG) group after 1 year following Preserflo MicroShunt implantation.
After 1 year following Preserflo MicroShunt implantation for primary open angle glaucoma (POAG) in White patients, 92.5% of eyes were medication-free, compared to 0% preoperatively, with a median postoperative medication use of 0 [0-0] in both high pressure glaucoma (HPG) and normal pressure glaucoma (NPG) groups.
The reduction of mean 24-hour IOP (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 high pressure glaucoma (HPG) and normal pressure glaucoma (NPG) groups after 1 year following Preserflo MicroShunt implantation in White patients with primary open angle glaucoma.
None of the White patients with primary open angle glaucoma (POAG) experienced severe adverse events or loss of vision after 1 year following Preserflo MicroShunt implantation.
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