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

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.

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; GroupA) or PreserFlo™ MicroShunt as a standalone procedure (15 eyes; Group B). The follow‑up time of the study was 12 months.

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/mm2 ; 12 months, 1968.5 ± 385.6 cells/mm2 ; P = 0.38; Group B: baseline, 2134.1 ± 382.6 cells/mm2 ; 12 months, 2094.4 ± 373.3 cells/mm2 , 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).

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.