ABSTRACT
Objective To investigate the clinical efficacy and safety of microcatheter assisted trabeculectomy on the treatment of childhood glaucoma.Methods A prospective case series method was performed.Sixteen childhood glaucoma with 22 eyes were enrolled in Henan Eye Hospital and Zhengzhou Second People's Hospital from December 2016 to August 2017.Nine males with 12 eyes and 7 females with 10 eyes were included,and the age ranged from 6 months to 8 years (median 4 years).All the subjects underwent microcatheter assisted trabeculectomy.The intraocular pressure changes were observed preoperation and 7 days,1 month and 6 months after surgery,and the postoperative complications were analyzed.This study was approved by the Ethics Committee of Henan Eye Hospital (2018KS-01) and Zhengzhou Secord People's Hospital (No.20161202001),and adhered to the tenets of the Declaration of Helsinki.Written informed consent was obtained from each guardia prior to any medical examination.Results Twenty eyes of 14 patients underwent microcatheter assisted trabeculectomy,the success rate was 90.91％.Twelve eyes were operated with full incision (incision range was 360°),8 eyes were performed with subtotal incision (incision range was 180°-330°),while the microcatheter could not pass over 90° in 2 eyes and was switch to traditional Harms knife trabeculotomy-trabeculectomy intraoperatively.The intraocular pressures of the 20 eyes that underwent microcatheter assisted trabeculectomy preoperation,7 days,1 month and 6 months after surgery were (26.55 ±4.38),(20.48 ± 3.62),(13.71 ± 6.35) and (12.67 ± 5.37) mmHg,respectively.The intraocular pressures in patients at different time points were statistically significant (F=112.771,P＜0.001).At the last follow-up,the intraocular pressures of 18 eyes were controlled.Among them,16 eyes achieved completely controlled intraocular pressure while 2 eyes returned to normal intraocular pressure after using ocular hypotensive drugs.The intraocular pressure of 2 eyes increased again after operation,and the intraocular pressure could not be controlled after combined use of anti-hypertensive drugs.All patients had no serious complications during and after the operation.Different degrees of anterior chamber hemorrhage occurred in 16 eyes during the surgery,and all the hemorrhages were absorbed within 1 week after surgery.Conclusions For children with glaucoma,microcatheter assisted trabeculectomy can achieve good intraocular pressure reduction effect without serious complications.
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>