Bimatoprost 0.01 % for previously treated patients with open-angle glaucoma or ocular hypertension in the Korean clinical setting.

PURPOSE: To evaluate the occurrence of hyperemia with, and efficacy of, bimatoprost 0.01 % for patients in Korea previously treated for open-angle glaucoma (OAG; including normal tension glaucoma) or ocular hypertension (OHT). METHODS: In this multicenter, observational study (Asia Pacific Patterns from Early Access of Lumigan 0.01 % in Korea; APPEAL Korea), patients with unachieved target intraocular pressure (IOP) despite previous treatment received bimatoprost 0.01 % daily for 12 weeks. The primary endpoint was incidence of hyperemia and its severity, graded using the standard 5-point photographic scale and grouped as "none to mild" and "moderate to severe". Hyperemia shifts were reported. IOP and adverse events (AEs) were recorded. RESULTS: Of 800 patients (intent-to-treat/safety population), 248 were switched from previous treatment to bimatoprost 0.01 % monotherapy. Hyperemia shifts from baseline at weeks 6 and 12 were unchanged (84.8, 89.8 %), improved (4.4, 4.8 %), or worsened (10.8, 5.4 %), respectively. The shift was significant at week 6 (P < 0.0001). Hyperemia did not worsen significantly in patients previously receiving a prostaglandin analog or prostamide (PGA/PSD). Baseline mean IOP ± SD was 17.0 ± 5.7 mmHg, decreasing to 14.6 ± 3.8 mmHg (P < 0.0001) after 6 weeks, and to 14.7 ± 3.6 mmHg (P < 0.0001) after 12 weeks. Patients switched from PGA or PSD (excluding bimatoprost 0.03 %) to bimatoprost 0.01 % experienced significant IOP reductions from baseline. Treatment-related ocular AEs were reported by 37 patients, the most common being hyperemia (7.3 %). CONCLUSIONS: This subanalysis of the APPEAL Korea study supports use of bimatoprost 0.01 % for previously treated patients with OAG (including normal tension glaucoma) or OHT who did not reach target IOP or were intolerant of previous treatment.

Bimatoprost 0.01% in treatment-naïve patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting.

BACKGROUND: This study evaluates the efficacy and tolerability (ie, occurrence and severity of hyperemia) of bimatoprost 0.01% in treatment-naïve patients with open-angle glaucoma (OAG) or ocular hypertension in the Korean clinical setting. METHODS: In this multicenter, open-label, observational study, treatment-naïve patients with OAG, including patients with normal-tension glaucoma (NTG, defined as IOP ≤21 mm Hg), or ocular hypertension received bimatoprost 0.01% once daily. Hyperemia was assessed at baseline and weeks 6 and 12, graded by a masked evaluator using a photonumeric scale (0, +0.5, +1, +2, +3), and grouped as (0 to +1) and (+2 to +3). Shifts between groupings were reported as no change, improved ([+2 to +3] to [0 to +1]), or worsened ([0 to +1] to [+2 to +3]). Other adverse events were monitored. Mean IOP changes from baseline at weeks 6 and 12 were reported. Supplemental analyses were conducted for IOPs >21 versus ≤21 mm Hg. RESULTS: Of 295 treatment-naïve patients included in the intent-to-treat/safety population, 73 (24.7%) had baseline IOP >21 mm Hg (mean, 25.7 ± 5.0 mm Hg) and 222 (75.3%) had baseline IOP ≤21 mm Hg (mean, 16.3 ± 3.0 mm Hg); 96.3% had hyperemia graded none (36.3%) to mild (17.3%). At week 12, hyperemia was graded none to mild in 83.7% (n = 220). Worsening occurred in 12.3% of patients by week 6 and 12.7% by week 12. Small improvements occurred in 0.8% and 0.5% of patients at weeks 6 and 12, respectively. Hyperemia scores were generally low and the majority of patients had no change in severity during the study. Mean IOP at weeks 6 and 12 was reduced to 16.4 ± 4.0 mm Hg (-34.5%; P < 0.0001) and 16.7 ± 3.9 mm Hg (-32.0%; P < 0.001) in the baseline-IOP >21 mm Hg group versus 13.3 ± 2.6 mm Hg (-17.8%; P < 0.001) and 13.7 ± 2.8 mm Hg (-15.9%; P < 0.001) in the baseline-IOP ≤21 mm Hg group, respectively. CONCLUSIONS: In treatment-naïve patients, bimatoprost 0.01% induced low shifts in worsening of hyperemia and significant reductions in IOP, regardless of baseline IOP. CLINICAL TRIAL REGISTRATION NUMBER: NCT01594970.

Flammer syndrome.

The new term Flammer syndrome describes a phenotype characterized by the presence of primary vascular dysregulation together with a cluster of symptoms and signs that may occur in healthy people as well as people with disease. Typically, the blood vessels of the subjects with Flammer syndrome react differently to a number of stimuli, such as cold and physical or emotional stress. Nearly all organs, particularly the eye, can be involved. Although the syndrome has some advantages, such as protection against the development of atherosclerosis, Flammer syndrome also contributes to certain diseases, such as normal tension glaucoma. The syndrome occurs more often in women than in men, in slender people than in obese subjects, in people with indoor rather than outdoor jobs, and in academics than in blue collar workers. Affected subjects tend to have cold extremities, low blood pressure, prolonged sleep onset time, shifted circadian rhythm, reduced feeling of thirst, altered drug sensitivity, and increased general sensitivity, including pain sensitivity. The plasma level of endothelin-1 is slightly increased, and the gene expression in lymphocytes is changed. In the eye, the retinal vessels are stiffer and their spatial variability larger; the autoregulation of ocular blood flow is decreased. Glaucoma patients with Flammer syndrome have an increased frequency of the following: optic disc hemorrhages, activated retinal astrocytes, elevated retinal venous pressure, optic nerve compartmentalization, fluctuating diffuse visual field defects, and elevated oxidative stress. Further research should lead to a more concise definition, a precise diagnosis, and tools for recognizing people at risk. This may ultimately lead to more efficient and more personalized treatment.

Relationship between 24-hour mean ocular perfusion pressure fluctuation and rate of paracentral visual field progression in normal-tension glaucoma.

PURPOSE: To investigate the relationship between unstable mean ocular perfusion pressure (MOPP) and the rate of paracentral visual field (PVF) progression in patients with medically treated normal-tension glaucoma (NTG). METHODS: The data of 157 eyes of 122 patients with NTG who were followed for more than 6 years (mean follow-up, 8.7 years ± 12.6 months) and had more than 5 reliable standard visual field (VF) tests were analyzed retrospectively. Groups in the highest, middle, and lowest tertiles of 24-hour MOPP fluctuation (HMF, MMF, and LMF, respectively) were compared in terms of rates of change of mean thresholds in the central 10° (PVF), 10° to 24°, and global areas by using a linear mixed model. Clinical factors associated with rapid PVF progression were also investigated. RESULTS: The LMF and HMF groups did not differ significantly in the mean global rate of VF changes (-0.52 vs. -0.71 dB/y; P = 0.07). The HMF group had a significantly faster progression of VF defects in the central 10° area than the LMF group (-1.02 vs. -0.54 dB/y; P < 0.001) but did not differ in terms of progression of VF defects in the peripheral 10° to 24° area (-0.39 vs. -0.495 dB/y; P = 0.425). PVF progression was significantly associated with 24-hour MOPP fluctuation (ß = -0.31, P < 0.001) and VF damage severity at initial presentation (ß = 0.134, P = 0.011). CONCLUSIONS: Medically treated NTG eyes with greater 24-hour MOPP fluctuations (HMF) had faster PVF defect progression than eyes with stable 24-hour MOPP (LMF). Twenty-four hour MOPP fluctuation associated significantly with PVF progression velocity.

Homeostatic response of intraocular pressure in the early period after sutureless phacoemulsification.

PURPOSE: To determine the homeostatic response of postoperative intraocular pressure (IOP) by analyzing postoperative IOP trends after sutureless phacoemulsification. SETTING: Asan Medical Center, Seoul, South Korea. DESIGN: Comparative case series. METHODS: Normotensive eyes were treated with sutureless phacoemulsification with in-the-bag posterior chamber IOL (PC IOL) implantation. The patients were randomly divided into 3 groups according to the intended immediate postoperative IOP as follows: Group 1, IOP less than 10 mm Hg; Group 2, IOP 10 to 21 mm Hg; Group 3, IOP over 21 mm Hg. The surgeon intentionally attempted supranormal, normal, or subnormal pressurization. The IOP was measured immediately after surgery and 2 hours, 4 hours, 1 day, 1 week, and 1 month postoperatively. RESULTS: Group 1 included 88 eyes (27.8%), Group 2 included 130 eyes (41.2%), and Group 3 included 98 eyes (31.0%). The mean IOP immediately after surgery was 6.4 mm Hg ± 2.0 (SD), 14.5 ± 3.2 mm Hg, and 27.0 ± 4.6 mm Hg, respectively, with significant differences between the 3 groups (P<.05). However, the IOP values were nearly normalized in the 3 groups 2 to 4 hours postoperatively. Twenty-eight eyes (8.9%) had an IOP lower than 5 mm Hg immediately after surgery in the absence of incision leakage. There were no postoperative complications related to hypotony. Thirty-one eyes (9.8%) had an IOP of at least 30 mm Hg immediately after surgery; the IOP normalized by 1 day postoperatively. CONCLUSION: In normal eyes that had uneventful sutureless phacoemulsification with in-the-bag PC IOL implantation, immediate postoperative high or low IOP did not affect the return to baseline levels.

Characteristics of visual field progression in medically treated normal-tension glaucoma patients with unstable ocular perfusion pressure.

PURPOSE: To investigate the characteristics of visual field (VF) progression in medically treated normal-tension glaucoma (NTG) patients (Koreans) with unstable ocular perfusion pressure (OPP). METHODS: One hundred one eyes of 101 NTG patients followed up for more than 4 years (mean follow-up, 6.2 years ± 12.1 months) were included. Modified Anderson criteria (MC) and linear regression analysis (LA) of VF mean deviation (MD) within the central 10° and 10° to 24° area were assessed for determining VF progression in groups with lowest (LMF) and highest (HMF) 24-hour mean OPP [MOPP = 2/3;(mean arterial pressure - IOP)] fluctuation. Kaplan-Meier analyses were used to compare the elapsed time of confirmed VF progression in the two groups. Hazard ratios (HRs) for the association between clinical risk factors including 24-hour MOPP and central VF progression were obtained by using Cox proportional hazards models. RESULTS: Three of 33 eyes in the LMF progressed, whereas 12 of 34 eyes in the HMF progressed within the central 10° according to the MC; the between-group difference was significant (P = 0.010). By LA within the central 10°, two eyes from the LMF and nine from the HMF groups showed progression (P = 0.025). The HMF showed a greater cumulative probability of central VF progression than the LMF, by both LA and MC (Kaplan-Meier analysis, P = 0.003, 0.015, log-rank test). In multivariate analysis, only 24-hour MOPP fluctuation was significantly associated with central VF progression (P = 0.014). CONCLUSIONS: The 24-hour MOPP fluctuation was the most consistent prognostic factor among various IOP, blood pressure, and clinical factors for central VF glaucomatous progression in our series of NTG eyes.

Potential benefit of intraocular pressure reduction in normal-tension glaucoma in South Korea.

PURPOSE: The aim of this study was to evaluate the potential benefit of intraocular pressure (IOP) reduction in normal tension glaucoma (NTG) Asian adult patients in South Korea. METHODS: This was a retrospective, multicenter analysis of 166 NTG Asian adult patients in South Korea. The patient population consisted of Korean patients with NTG with at least 5 years of records available for evaluation. Patients all had typical glaucomatous optic-disc and/or visual-field changes but had never had a recorded IOP >21 mmHg. RESULTS: Overall, 48 (29%) patients were progressed and 116 (71%) were stable over the follow-up period. Of patients with IOPs or=15 mmHg (27/73) 37% progressed (P = 0.041). The mean IOP for the stable group was 14.0 +/- 1.8 mmHg, whereas with the progressed group the average mean IOP was 14.4 +/- 1.6 mmHg (P = 0.20). The mean peak IOP was 17.4 +/- 2.2 mmHg in the stable group and 17.8 +/- 2.0 mmHg in the progressed group (P = 0.26). Multivariate linear regression analysis did not any identify independent risk factors for progression, including age, gender, or mean and peak IOP. CONCLUSIONS: This study provides initial evidence that Korean patients with normal-tension glaucoma, treated to lower IOPs, may have a decreased incidence of progression over 5 years than those patients with higher IOPs. More research is required to confirm this finding.