REAL-WORLD EFFECTIVENESS AND SAFETY OF RANIBIZUMAB TREATMENT IN PATIENTS WITH AND WITHOUT POLYPOIDAL CHOROIDAL VASCULOPATHY: Twelve-Month Results From the LUMINOUS Study.

PURPOSE: To evaluate the real-world effectiveness and safety of intravitreal ranibizumab 0.5 mg in treatment-naive patients with and without polypoidal choroidal vasculopathy (PCV). METHODS: Assessment of neovascular age-related macular degeneration patients with or without PCV after 12 months of ranibizumab treatment during the LUMINOUS study. Outcome measures were visual acuity and central retinal thickness changes from baseline and the rate of ocular adverse events. RESULTS: At baseline, 572 and 5,644 patients were diagnosed with and without PCV, respectively. The mean visual acuity gain from baseline at Month 12 in the PCV and non-PCV groups was +5.0 and +3.0 letters, respectively; these gains were achieved with a mean of 4.4 and 5.1 ranibizumab injections. Eighty percent of PCV patients and 72.2% of non-PCV patients who had baseline visual acuity ≥73 letters maintained this level of vision at Month 12; 20.6% and 17.9% of patients with baseline visual acuity <73 letters achieved visual acuity ≥73 letters in these groups. Greater reductions in central retinal thickness from baseline were also observed for the PCV group versus the non-PCV group. The rate of serious ocular adverse events was 0.7% (PCV group) and 0.9% (non-PCV group). CONCLUSION: LUMINOUS confirms the effectiveness and safety of ranibizumab in treatment-naive patients with PCV.

Initial treatment for polypoidal choroidal vasculopathy: Ranibizumab combined with photodynamic therapy or fixed-dosing aflibercept monotherapy.

PURPOSE: To compare the 2-year outcomes of combination therapy using intravitreal ranibizumab and photodynamic therapy with those of fixed-dosing intravitreal aflibercept monotherapy as initial treatment for treatment-naïve polypoidal choroidal vasculopathy. METHODS: We retrospectively reviewed 63 eyes of 61 patients with treatment-naïve polypoidal choroidal vasculopathy who had undergone at least 24 months of follow-up. In total, 43 eyes underwent intravitreal ranibizumab-photodynamic therapy combination therapy and 20 eyes underwent fixed-dosing intravitreal aflibercept monotherapy. Visual outcomes and the number of treatments were compared between the two groups. RESULTS: The mean logarithm of minimal angle of resolution best-corrected visual acuity significantly improved from 0.48 ± 0.41 at baseline to 0.30 ± 0.47 at 24 months in the intravitreal ranibizumab-photodynamic therapy group (p = .0002) and from 0.30 ± 0.18 at baseline to 0.16 ± 0.18 at 24 months in the intravitreal aflibercept group (p = .004), with no significant intergroup differences. The mean number of intravitreal ranibizumab or intravitreal aflibercept injections over 24 months was 5.7 ± 4.5 in the intravitreal ranibizumab-photodynamic therapy group and 12.2 ± 3.8 in the intravitreal aflibercept group (p < .0001). CONCLUSION: The intravitreal ranibizumab-photodynamic therapy combination therapy was noninferior to fixed-dosing intravitreal aflibercept monotherapy in improving visual acuity and required fewer injections.

Clinical results of Trabectome surgery for open-angle glaucoma.

BACKGROUND: The purpose of this study was to determine outcomes when using Trabectome surgery and to evaluate factors associated with its effects in primary open-angle glaucoma (POAG) and exfoliation glaucoma (EXG). METHODS: This was a prospective, non-randomized, observational, comparative cohort study in which Trabectome surgery was used alone in patients with POAG or EXG. Trabectome surgery was considered to have failed when at least one of the following three criteria was fulfilled: intraocular pressure (IOP) ≥21 mmHg and a <20% reduction below the baseline IOP on two consecutive follow-up visits 3 months or more after surgery; need for additional glaucoma surgery; and an increase in number of medications compared with baseline. RESULTS: The subjects were 32 males (34 eyes) and 46 females (48 eyes). POAG was observed in 43 eyes and EXG in 39 eyes. IOP after Trabectome surgery decreased significantly from 22.3±6.8 mmHg at baseline to 14.0±3.9 mmHg (23.0% reduction) at month 24 in all cases (P<0.0000). The success rate at 2 years was 51.2% for all cases (POAG, 50.9%; EXG, 49.2%). There was no significant difference in success rate between POAG and EXG (P=0.91). Preoperative IOP (P=0.033) and number of medications (P=0.041) were significant factors for surgical success/failure in multivariate logistic regression. No serious complications were observed. CONCLUSION: Trabectome surgery achieved favorable IOP control and was equally effective in patients with POAG and those with EXG. Its effects were influenced by preoperative IOP and number of preoperative medications.

Plateau iris in Japanese patients with primary angle closure and primary angle closure glaucoma.

PURPOSE: To determine the prevalence of plateau iris in Japanese patients with primary angle closure (PAC) and primary angle closure glaucoma (PACG) and analyze the biometric parameters in patients with plateau iris using ultrasound biomicroscopy (UBM). METHODS: In this cross-sectional observational study, subjects aged >50 years with PAC and PACG who had previously undergone a patent laser peripheral iridotomy underwent UBM in one eye. UBM images were qualitatively analyzed using standardized criteria. Plateau iris in a quadrant was defined by anteriorly directed ciliary body, absent ciliary sulcus, steep iris root from its point of insertion followed by a downward angulation, flat iris plane, and irido-angle contact. At least two quadrants had to fulfill these UBM criteria for an eye to be classified as having plateau iris. A-scan biometry was used to measure anterior segment parameters. RESULTS: Ninety-one subjects with PAC (58 subjects) or PACG (33 subjects) and 68 normal controls were recruited. The mean (standard deviation) ages of PAC and PACG patients and normal controls were 73.5 (6.2) and 72.6 (7.3), respectively. Based on UBM criteria, plateau iris was found in 16 eyes (17.6%) of 91 eyes. In these 16 eyes, quadrant-wise analysis showed ten eyes (62.5%) had plateau iris in two quadrants; four eyes (25%) had plateau iris in three quadrants; and two eyes (12.5%) had plateau iris in four quadrants. Anterior chamber depth, lens thickness, axial length, lens position, and relative lens position were not statistically significant between the group having plateau iris and that not having plateau iris, respectively. CONCLUSION: Approximately 20% of Japanese subjects with PAC and PACG with a patent laser peripheral iridotomy were found to have plateau iris on UBM. No morphological difference was noted in the anterior segment of the eye between those with or without plateau iris.

Peripheral iris thickness and association with iridotrabecular contact after laser peripheral iridotomy in patients with primary angle-closure and primary angle-closure glaucoma.

PURPOSE: To investigate the relation between the quantitative iris parameters and iridotrabecular contact (ITC) in patients with primary angle-closure (PAC) and PAC glaucoma (PACG). MATERIALS AND METHODS: PAC and PACG with laser peripheral iridotomy were recruited prospectively. Anterior-segment optical coherence tomography (ASOCT) was performed under light and dark conditions, and scans were taken along the vertical and horizontal axes. Iris thickness at 500 µm (IT500) and 750 µm (IT750) from the scleral spur, maximal iris thickness (MIT), and cross sections of the iris area (I-Area) were measured by using software. ITC was defined by the ASOCT as the contact between the peripheral iris and angle wall anterior to the scleral spur. The ITC(+) and ITC(-) groups were defined as eyes that had ITC in two or more quadrants and in no or one quadrant, respectively. RESULTS: A total of 79 eyes of 60 patients (consisting of 48 PAC and 31 PACG) were recruited. The prevalence of superior, inferior, temporal, and nasal ITC was 44 eyes (55.7%), 48 eyes (60.8%), 18 eyes (22.8%), and 16 eyes (20.2%), respectively. These iris parameters of the inferior quadrant, which had the highest prevalence of all the quadrants, were used for the analysis. After adjusting for age, sex, pupil size, and central anterior chamber depth, mean values of IT500 and IT750 were significantly greater in the ITC(+) group than the ITC(-) group (P<0.05). Multivariate-adjusted odds ratios of parameters for the ITC(+) group compared with the ITC(-) group were: IT500, 1.9 (P=0.029); IT750, 2.0 (P=0.011), MIT, 1.4 (P=0.244), and I-Area, 0.97 (P=0.406), respectively, per 0.1-unit increase. CONCLUSION: Peripheral iris thickness is associated with ITC in patients with angle closure.

Comparison of corneal safety and intraocular pressure-lowering effect of tafluprost ophthalmic solution with other prostaglandin ophthalmic solutions.

PURPOSE: The benzalkonium chloride (BAK) content of tafluprost ophthalmic solution (Tapros(®): tafluprost) has been reduced to balance corneal safety and preservative effectiveness (old formulation: 0.01%; new formulation: 0.001%). However, no reports have been published on its clinical effect. Therefore, we conducted a clinical research study to compare the safety of BAK-reduced tafluprost on the ocular surface with other prostaglandin ophthalmic solutions. METHODS: This clinical study included 28 glaucoma patients (28 eyes) with a treatment history of latanoprost ophthalmic solution (Xalatan(®)) or travoprost ophthalmic solution (Travatan Z(®)), who presented with corneal epithelial disorders. The subjects were switched to BAK-reduced tafluprost, and its effect on the ocular surface was examined after 1 and 2 months of treatment [using fluorescein staining score, hyperemia, tear film breakup time, and intraocular pressure (IOP) lowering]. RESULTS: In all analyzed subjects (N=27), the fluorescein staining score was significantly improved after switching to BAK-reduced tafluprost (P<0.0001). Conversely, the IOP-lowering effect was not notably changed. The subjects switched from latanoprost (n=10) showed significant improvement in fluorescein staining score (P<0.05) as well as in IOP lowering (P<0.01). The subjects switched from travoprost (n=17) also showed significant improvement in fluorescein staining score (P<0.001), but without a significant change in IOP lowering. CONCLUSIONS: Tafluprost with reduced BAK has potential as a superior antiglaucoma drug, not only for its IOP-lowering effect, but also for its good corneal safety profile.

Additive intraocular pressure-lowering effect of dorzolamide 1%/timolol 0.5% fixed combination on prostaglandin monotherapy in patients with normal tension glaucoma.

PURPOSE: To evaluate the intraocular pressure (IOP)-lowering effect of adding dorzolamide 1.0%/timolol 0.5% fixed combination (DTFC) to prostaglandin analogs (PGAs) as monotherapy in patients with normal tension glaucoma. METHODS: A prospective, clinical, case-controlled study of patients with normal tension glaucoma. Patients had been on a once-daily night dose of prostaglandins (PGs) as monotherapy and then received DTFC added to PGs for 8 weeks. The IOP was measured at 9 am, week 0 (baseline), week 4, and week 8. RESULTS: The baseline IOP of 40 patients who had previously been treated by prostaglandin monotherapy was 15.6 ± 2.0 mmHg at baseline. The IOPs at 4 and 8 weeks after adding DTFC to PGs were 13.5 ± 2.1 mmHg and 13.7 ± 2.2 mmHg, respectively. Significant decrease of the IOP was observed at each time point of measurement as compared with the baseline IOP before adding DTFC (P = 0.01). The percent IOP reduction from the baseline IOP at week 4 and week 8 was 13.5% ± 12.3% and 11.7% ± 13.1%, respectively. The percentage of patients who achieved 10% or more IOP reduction from the baseline IOP at week 8 was 62.5%. The baseline IOP was significantly correlated with the percent IOP reduction at week 8 (P = 0.03, r = 0.34). CONCLUSION: DTFC therapy added to PGAs as glaucoma monotherapy is effective in patients with normal tension glaucoma.

[A brainstem variant of reversible posterior leukoencephalopathy syndrome (RPLS) presenting with visual disturbance].

A 40-year-old woman noticed blurred vision of the right eye. The optic disc edema of bilateral eyegrounds was noted, and brain MRI showed abnormal signals of the brainstem at a neurosurgical clinic. On her first visit, blood pressure was as remarkably high as 250/130 mmHg. Neurologically, only optic disc edema of bilateral eye-grounds was found. Both T2-weighted MRI and FLAIR showed hyperintense signal areas mainly from the ventral pons to medulla oblongata. These areas were not enhanced with gadolinium. About three weeks after the administration of an antihypertensive agent, brain MRI revealed no abnormal signal. About three months later, the blurred vision disappeared and ophthalmological abnormalities subsided. We diagnosed her with a brainstem variant of RPLS, presenting with visual disturbance caused by hypertensive retinopathy.