PreserFlo™ MicroShunt Combined with Phacoemulsification versus PreserFlo™ MicroShunt as a Standalone Procedure in Patients with Medically Resistant Open-Angle Glaucoma.

Abstract

Purpose:To compare the efficacy and safety of PreserFlo™ MicroShunt (Santen, Osaka, Japan) combined with phacoemulsification to PreserFlo™ MicroShunt as a standalone procedure in eyes with moderate to advanced open-angle glaucoma.Methods:In an observatory, prospective, clinical study, 30 patients (30 eyes) with moderate to advanced angle glaucoma were allocated to either PreserFlo™ MicroShunt combined with phacoemulsification (15 eyes; Group A) or PreserFlo™ MicroShunt as a standalone procedure (15 eyes; Group B). The follow-up time of the study was 12 months.Results:Average intraocular pressure (IOP) at 12 months was 11.62 ± 1.6 mmHg in Group A and 13.8 ± 3.6 mmHg in Group B, which was significantly lower than baseline IOP (Group A: 23.47 ± 8.99 mmHg, P < 0.001; Group B: 23.4 ± 8.68 mmHg, P < 0.001). The absolute reduction of IOP within the 12 postoperative months was not significantly different between the two groups (P = 0.056). The number of the topical medications that were administered 12 months after ocular surgery was 0 in Group A and 0.6 ± 0.8 in Group B, compared to 3.13 ± 1.02 in Group A (P < 0.001) and 2.4 ± 1.45 in Group B (P = 0.004) at baseline. Phacoemulsification combined with PreserFlo™ MicroShunt significantly reduced the number of antiglaucoma agents after 12 months compared to the standalone procedure (P = 0.026). One eye in Group A was referred for bleb revision due to bleb fibrosis and a consequent acute postoperative rise in IOP. One eye in Group A required transscleral cyclophotocoagulation with MicroPulse® laser. One bleb revision was also necessary in Group B at the 4th postoperative week. Endothelial cell density did not significantly change over 12 months in either group (Group A: baseline, 2017.3 ± 346.8 cells/mm[2]; 12 months, 1968.5 ± 385.6 cells/mm[2]; P = 0.38; Group B: baseline, 2134.1 ± 382.6 cells/mm[2]; 12 months, 2094.4 ± 373.3 cells/mm[2], P = 0.42). The PreserFlo™ MicroShunt combined with phacoemulsification produced higher absolute success rates after 12 months in patients with moderate to advanced open-angle glaucoma than the PreserFlo™ MicroShunt as standalone procedure (Group A: 80% and Group B: 60%, P = 0.022).Conclusions:In eyes with moderate to advanced open-angle glaucoma, PreserFlo™ MicroShunt with or without phacoemulsification is effective in reducing IOP and the number of the antiglaucoma agents with a very small incidence of complications and subsequent glaucoma surgeries. However, adding phacoemulsification to PreserFlo™ MicroShunt successfully reduces IOP without the need for ongoing topical medications as are needed after the standalone procedure.