We examined the effectiveness of trabeculectomy in decreasing the slope of mean deviation (MD) in Japanese patients with progressive normal-tension glaucoma (NTG) at low intraocular pressure (IOP) levels. The charts of patients who had undergone initial trabeculectomy with adjunctive mitomycin C for progressive NTG with medically controlled IOP < 15 mmHg in 2010–2013 were retrospectively reviewed. Seventeen eyes of 13 NTG patients who had undergone at least 5 times of visual field (VF) examinations in both of preoperatively and postoperatively with postoperative follow-up of ≥ 2 years were enrolled. Preoperative and postoperative MD slopes were compared to evaluate the effectiveness of trabeculectomy in slowing progression of VF. Mean IOP (8.1 ± 2.9 mmHg) and number of IOP-lowering medications (0.8 ± 1.5) were significantly lower postoperatively than preoperatively (13.9 ± 0.9 mmHg; P < 0.001 and 3.0± 0.4; P < 0.0001). In total, 91.7% of eyes with single-digit IOP postoperatively showed improvement in MD slope, whereas only 20.0% of eyes with IOP ≥ 10 mmHg postoperatively showed the improvement. Three eyes (17.6%) showed a decrease in visual acuity (VA) of ≥ 0.1 unit; this group had a lower mean postoperative IOP (6.0 ± 1.0 vs. 8.6 ± 3.0 mmHg; P = 0.1717) and a higher mean IOP reduction rate (56.2 vs. 38.5%; P = 0.8296) than eyes with a VA decrease of < 0.1 unit or no change. Thus, in this analysis of Japanese NTG patients with medically controlled IOP < 15 mmHg, achieving an IOP < 10 mmHg with trabeculectomy was beneficial for reducing the VF progression rate in progressive NTG at low IOP levels. However, an IOP < 7 mmHg by surgery would be required careful attention to VA decline.

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Met98Lys is a risk-associated alteration for open-angle glaucoma, including POAG and NTG, in the Japanese population as initially reported. The amino acid-preserving polymorphism, c.412G > A, may be a genetic risk factor for the progression of open- angle glaucoma in this Japanese population.

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BackgroundThe purpose of this study was to assess the safety and efficacy of fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC) compared with concomitant brinzolamide 1% and timolol 0.5% (BRINZ + TIM) in Japanese patients with open-angle glaucoma (primary open-angle, exfoliation, pigmentary) or ocular hypertension.MethodsThis randomized, double-masked, multicenter, parallel-group, positive-control, Phase III study was conducted in Japan and included patients aged ≥20 years. Baseline intraocular pressure was assessed after 4 weeks of treatment with timolol 0.5%. Patients were randomized to twice-daily BRINZ/TIM-FC or BRINZ + TIM for 8 weeks (treatment phase). The primary endpoint was mean intraocular pressure reduction from baseline to week 8 at 11 am, at which time noninferiority of BRINZ/TIM-FC versus BRINZ + TIM was evaluated. Data were analyzed using repeated-measures analysis of covariance and t-tests. Adverse events and ophthalmic/physiologic variables were assessed.ResultsIn total, 319 patients of mean age 64±12 years were enrolled in the treatment phase. BRINZ/TIM-FC and BRINZ + TIM were associated with reductions in mean intraocular pressure from baseline throughout the study (ranges −2.5 to −3.4 mmHg and −2.7 to −3.3 mmHg, respectively). Mean between-group differences in intraocular pressure reduction ranged from 0 to −0.3 mmHg; the upper limit of the 97.5% confidence interval for week 8 at 11 am was <1.1 mmHg, indicating noninferiority of BRINZ/TIM-FC. Treatment-related adverse events were observed in 3% and 12% of patients receiving BRINZ/TIM-FC and BRINZ + TIM, respectively. No substantial changes in other safety parameters were reported.ConclusionTwice-daily BRINZ/TIM-FC reduced intraocular pressure by levels similar to concomitant BRINZ + TIM in Japanese patients with open-angle glaucoma or ocular hypertension and was noninferior to BRINZ + TIM. Both treatments were well tolerated.