Published in:
01-09-2017 | Clinical Investigation
Safety and effectiveness of gold glaucoma micro shunt for reducing intraocular pressure in Japanese patients with open angle glaucoma
Authors:
Masaki Tanito, Etsuo Chihara
Published in:
Japanese Journal of Ophthalmology
|
Issue 5/2017
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Abstract
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.