RESUMO
Objective:To compare the efficacy and safety of intravitreal injection of anti-vascular endothelial growth factor drug conbercept and intravitreal dexamethasone implant Ozurdex in the treatment of diabetic macular edema (DME).Methods:A randomized controlled clinical study was performed.Thirty-six DME patients (36 eyes) were enrolled in Weifang Eye Hospital from March 2018 to June 2019.The patients were randomized into Ozurdex group and conbercept group via a random number table, with 18 eyes in each group.Patients received Ozurdex injection once, which was maintained for 6 months, or conbercept injection once a month for 3 times according to grouping.Before and after treatment, the best corrected visual acuity (BCVA) was examined with the International Standard Visual acuity chart and converted to logarithm of minimal angle resolution unit.The intraocular pressure (IOP) was measured using a non-contact tonometer.The central retinal thickness (CRT) was detected by optical coherence tomography (OCT).This study followed the Declaration of Helsinki and was approved by the Ethics Committee of Weifang Eye Hospital.Results:All patients were followed up for 6 months.In Ozurdex group, the BCVA pre-injection and at 1 month, 3, 4, 6 months after the first injection was 0.59±0.22, 0.53±0.20, 0.41±0.16, 0.38±0.19 and 0.56±0.19, respectively.The BCVA at 1 month, 3 and 4 months after the first injection were better than that before injection, and the differences were statistically significant (all at P<0.05).In conbercept group, the BCVA pre-injection and at 1 month, 3, 4, 6 months after the first injection were 0.60±0.23, 0.51±0.17, 0.29±0.13, 0.56±0.18 and 0.60±0.18, respectively.The BCVA at 1 month and 3 months after the first injection were better than that before injection, showing statistically significant differences (all at P<0.05).The CRT at 1 month, 3 and 4 months after the first injection were significantly lower than that before treatment in both the two groups (all at P<0.05).The CRT pre-injection was (498.61±77.14)μm in Ozurdex group, which was significantly higher than (462.17±48.74)μm at 6 months after the first injection ( P<0.05).No significant difference in CRT was found between pre-injection and 6 months after the first injection in conbercept group ( P>0.05).The incidence of high IOP in Ozurdex group was 33.3%(6/18), which was higher than 5.56%(1/18) in conbercept group, with a significant difference ( χ2=4.433, P=0.035).No adverse effects such as aggravation of cataract, lens injury, endophthalmitis, vitreous hemorrhage and retinal detachment was found during the follow-up. Conclusions:For DME, both conbercept and Ozurdex can improve BCVA and reduce CRT.Ozurdex shows durable efficacy and needs fewer injections than conbercept, but conbercept has less effect on IOP and is safer than Ozurdex.
RESUMO
Objective:To observe the effect of non-vitrectomy in the treatment of idiopathic macular epiretinal membranes (IMEM).Methods:This study is a randomized controlled trial. From December 2017 to December 2018, 60 IMEM patients (60 eyes) diagnosed in Weifang Eye Hospital were included in the study. BCVA, intraocular pressure (IOP) and OCT were performed in all patients. The BCVA examination was performed using the international standard visual acuity chart, which was converted to logMAR. The CMT was measured by OCT. According to the surgical methods, the patients were divided into non-vitrectomy group and control group, 30 patients (30 eyes) in each group. The age ( t=1.723), logMAR BCVA ( t=1.703), CMT ( t=-0.956), IOP ( t=-1.434) were not significantly different between the two groups ( P=0.090, 0.094, 0.343, 0.157). 23G vitreous cutting system was used in all eyes. The macular epiretinal membranes was removed by non-vitrectomy in the non-vitrectomy group and by vitrectomy in the control group. The relevant examination with the same equipment and methods before the operation at 1 week and 1, 3, 6 months after operation. The time of surgery, the changes of BCVA, CMT and postoperative complications in the two groups were observed comparatively. Variance analysis of repeated measurements was performed for the comparison of BCVA, CMT and IOP after surgery in the two groups. Wilcoxon rank sum test of two independent samples was performed for the degree of vision improvement. The incidence of postoperative complications was compared by χ2 test. Results:At 6 months after operation, BCVA increased in 24 eyes (80%) and unchanged in 6 eyes (20%) in the non-vitrectomy group. Compared with preoperative BCVA, the difference was statistically significant ( P<0.05). BCVA increased in 25 eyes (83.4%), unchanged in 4 eyes (13.3%) and decreased in 1 eye (3.3%) in the control group. Compared with preoperative BCVA, the difference was statistically significant ( P<0.05). There was no significant difference between the two groups in BCVA improvement degree after operation ( Z=-0.26, P>0.05). At 6 months after operation, the average logMAR BCVA was statistically significant compared with the preoperative in the non-vitrectomy group ( P=0.002, 0.005) and control group ( P=0.004, <0.001). Visual stability occurred 1 month after operation in the non-vitrectomy group and 3 months after operation in the control group. The effective operative time of the non-vitrectomy group and control group was 4.50±1.41 and 15.50±2.33 min, respectively. The difference of effective operation time between the two groups was statistically significant ( t=-22.12, P <0.05). After surgery, no significant complications were found in the non-vitrectomy group. In the control group, there were 3 eyes with low IOP and 1 eye with macular hole during operation. Conclusions:Non-vitrectomy and vitrectomy have similar effects on IMEM. Non-vitrectomy has short effective operation time, faster recovery after surgery and no obvious complications.