Safety and effectiveness of gold glaucoma micro shunt for reducing intraocular pressure in Japanese patients with open angle glaucoma.

PURPOSE: To assess the safety and effectiveness of the SOLX gold shunt (GS) in reducing intraocular pressure (IOP) in Japanese patients with open angle glaucoma (OAG).

METHODS: 24 eyes of 24 subjects [mean age of 68.9 ± 12.7 years; 13 (54%) women; 16 (67%) POAG, 7 (29%) pseudoexfoliation glaucoma, and 1 (4%) steroid response glaucoma] were implanted with the GS either with or without cataract surgery. Best-corrected visual acuity (BCVA), IOP, corneal endothelial cell density (CECD), anterior chamber (AC) flare, surgical complications, and required interventions were monitored at baseline, and 1 day, 1 week, 1, 3 and 6 months, and 1 year postoperatively.

RESULTS: Baseline IOP of 21.3 ± 4.1 mmHg and glaucoma medications of 3.5 ± 1.0 were significantly reduced at every follow-up visit. At 1 year postoperatively, IOP was 16.4 ± 5.8 mmHg (23% reduction from baseline, p < 0.0001) with use of 2.1 ± 1.1 medications (40% reduction from baseline, p = 0.0002). Intraoperative hyphema occurred in 5 (21%) eyes. Transient bleb formation occurred in 20 (83%) eyes, and AC cell was reported in 17 (71%) eyes. Inflammation-related complications such as posterior and anterior synechiae, or iritis/keratic precipitates tended to occur during late postoperative periods. At 1 year, BCVA was unchanged or improved in 23 (96%) eyes. AC flare was elevated at 1 week postoperatively and later. CECD declined at 3 months and 1 year postoperatively.

CONCLUSIONS: The GS is effective in reducing IOP in Japanese patients with OAG. Chronic inflammation in AC might be associated with late onset complications.