ABSTRACT
Background Attack of primary acute angle-closure glaucoma (PAACG) often cause damage of retinal function.To measure the structural change after acute angle-closure glaucoma attack is of an important clinical significance.Flourier domain OCT(FD-OCT) is available.Objective This study was to measure and compare the thickness of peripapillary and macular retinal nerve fiber layer (RNFL) and macular volume in PAACG patients and normal subjects.Methods A case-controlled study was designed.Twenty-five eyes after acute angle-closure glaucoma attack and 25 fellow eyes were collected from April,2011 to February,2012 in Affiliated Eye Hospital of Wenzhou Medical College,and 25 eyes of normal subjects with the matched age and gender were enrolled at the same period.The thicknesses of RNFL and macula as well as the volumes of macula were measured by FD-OCT in all the eyes 2 weeks after acute angle-closure glaucoma attack.The outcomes were compared among the attacked eyes,fellow eyes and normal control eyes.Results The average thicknesses of RNFL were (125.72 ± 28.57),(108.36 ±9.31) and (106.10± 10.97)μm in the attacked eyes,fellow eyes and normal control eyes,showing a significant increase in the attacked eyes (all at P ＜ 0.05).The RNFL thickness values in the superior,interior and nasal quadrants at optical disc were significantly higher in the attacked eyes than those of the fellow eyes and normal control eyes (all at P＜0.05),but no significant differences were found in temporal and temporal-lower quadrants among the three groups (P=0.081,0.766).The thickness values of macular area were (283.72 ± 18.33),(280.28 ± 16.85) and (289.14±10.60)μm in the attacked eyes,fellow eyes and normal control eyes,with no significant difference among them (Fgroup =2.048,P =0.136),and fellow eyes were significantly reduced in comparison with the normal control group (P＜0.05),and those in the attacked eyes was not significantly reduced in comparison with the normal control group (P =0.224).The macular volumes were (5.589±0.355),(5.532±0.325) and (5.720±0.241)mm3in the attacked eyes,fellow eyes and normal eyes,without statistically significant difference among them (Fgup =1.027,P=0.363).The macular thickness values were lower in the outer race than those of the inner race and followed the pattern of nasal ＞superior＞ inferior＞temporal quadrants.At the temporal,superior,nasal and inferior quadrants of inner race,the temporal quadrant of the outer race,the central area,the macular thickness and volume values were declined in the attacked eyes and fellow eyes compared with the normal control eyes (all at P＜0.05).Conclusions The edema of RNFL is more serious than that of macula in the eyes within 2 weeks after acute angleclosure glaucoma attack.The retinas of macular zone are thinner,and the macular volumes are smaller in the attacked eyes and fellow eyes than those in the normal control eyes.
ABSTRACT
<p><b>BACKGROUND</b>Lowering intraocular pressure (IOP) is currently the only therapeutic approach in primary open-angle glaucoma. and the fixed-combination medications are needed to achieve sufficiently low target IOP. A multicenter prospective study in the Chinese population was needed to confirm the safety and efficacy of Bimatoprost/Timolol Fixed Combination Eye Drop in China. In this study, we evaluated the safety and efficacy of Bimatoprost/Timolol Fixed Combination with concurrent administration of its components in Chinese patients with open-angle glaucoma or ocular hypertension.</p><p><b>METHODS</b>In this multicenter, randomized, double-masked, parallel controlled study, patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy with either topical β-blockers or prostaglandin analogues were randomized to one of two active treatment groups in a 1:1 ratio at 11 Chinese ophthalmic departments. Bimatoprost/timolol fixed combination treatment was a fixed combination of 0.03% bimatoprost and 0.5% timolol (followed by vehicle for masking) once daily at 19:00 P.M. and concurrent treatment was 0.03% bimatoprost followed by 0.5% timolol once daily at 19:00 P.M. The primary efficacy variable was change from baseline in mean diurnal intraocular pressure (IOP) at week 4 visit in the intent-to-treat (ITT) population. Primary analysis evaluated the non-inferiority of bimatoprost/ timolol fixed combination to concurrent with respect to the primary variable using a confidence interval (CI) approach. Bimatoprost/timolol fixed combination was to be considered non-inferior to concurrent if the upper limit of the 95% CI for the between-treatment (bimatoprost/timolol fixed combination minus concurrent) difference was ≤ 1.5 mmHg. Adverse events were collected and slit-lamp examinations were performed to assess safety. Between-group comparisons of the incidence of adverse events were performed using the Pearson chi-square test or Fisher's exact test.</p><p><b>RESULTS</b>Of the enrolled 235 patients, 121 patients were randomized to receive bimatoprost/timolol fixed combination and, 114 patients were randomized to receive concurrent treatment. At baseline the mean value of mean diurnal IOP was (25.20 ± 3.06) mmHg in the bimatoprost/timolol fixed combination group and (24.87 ± 3.88) mmHg in the concurrent group. The difference between the treatment groups was not statistically significant. The mean change from baseline in mean diurnal IOP (± standard deviation) in the bimatoprost/timolol fixed combination group was (-9.38 ± 4.66) mmHg and it was (-8.93 ± 4.25) mmHg in the concurrent group (P < 0.01). The difference between the two treatment groups (bimatoprost/timolol fixed combination minus concurrent) in the change from baseline of mean diurnal IOP was -0.556 mmHg (95% CI: -1.68, 0.57, P = 0.330). The upper limit of the 95% CI was less than 1.5 mmHg, the predefined margin of non-inferiority. Adverse events occurred in 26.4% (32/121) of the bimatoprost/timolol fixed combination patients and 30.7% (35/114) of the concurrent patients. The most frequent adverse event was conjunctival hyperemia, which was reported as treatment related in 16.5% (20/121) in the bimatoprost/timolol fixed combination group and 18.4% (21/114) in the concurrent group (P > 0.05).</p><p><b>CONCLUSIONS</b>Bimatoprost/Timolol Fixed Combination administered in Chinese patients with open-angle glaucoma or ocular hypertension was not inferior to concurrent dosing with the individual components. Safety profiles were similar between the treatment groups.</p>