| Background:Diabetic retinopathy(DR)is one of the major complications of diabetes and is animportantetiological factorfor vision impairment.Clinically,about 25 percent of DR will suffer diabetic macular edema(DME).The main clinical features of DME include the decrement of central vision,visual distortion,and central scotoma.The treatment for DME contains laserphotocoagulation,corticosteroids and anti-VEGF treatment.First,laser photocoagulation can relieve DME,reduce the incidence of visual loss,however,it resulted in a destructive structure change,leading to peripheral visual field contraction,night blindness and color deficiency.Second,corticosteroids has potent anti-inflammatory effects,and triamcinolone acetonide(TA),as a usually used long-term corticosteroid,has three administration routes : intravitreal injection,peribulbar injection,sub-Tenon’s injection and so on.? intravitreal injection of TA: it can effectively improve DME,increase visual acuity and alleviate macular thickness,but the incidence of complications is high,such as intraocular pressure increment and cataract.? peribulbar injection of TA: it is an extraocular administration route,avoiding the risk intravitreal injection,but its efficacy is poor.? sub-Tenon’s injection of TA: it can improve DME,but the effect is not good,and has the risk of ocular puncture.Third,Anti-VEGF drugs: intravitreal injection of anti-VEGF drugs can effectively improve visual acuity,alleviate macular thickness,yet it is an invasive administration route,will give rise to some complications such as endophthalmitis,vitreous hemorrhage,retinal detachment and so on.Moreover,the price of anti-VEGF drugs is expensive,and it requires repeated injections during the treatment,which will bring heavy economic burden to DME patients.Objective:Based on the existing clinical trial,it is urgent for us to explore a new way for the treatment of DME,which has satisfied efficacy,small risk and low cost.So we use a self-made innovative device to treat DME with post-sclera injection of TA,comparing respectively with the traditional method and the anti-VEGF drugs to evaluate its efficacy and safety.Methods:Observe one: 55 patients with DME were recruited,being divided into three groups: TA post-sclera injection group(test group),TA peribulbar injection group(control group 1),and laser treatment group(control group 2).The test group received post-sclera injection of TA(20mg),the control group 1 received peribulbar injection of TA(20mg),the control group 2 received laser photocoagulation treatment.The best corrected visual acuity(BCVA),the average macular thickness and the mean photosensitivity was analysed at week1,month 1 and months 3 after treatment.The test group compared with the control group 1 and the control group 2 respectively.Observe two: 40 patients with DME were recruited,being divided into two groups: TA post-sclera injection group(test group),and anti-VEGF intravitreal injection group(control group).The test group received post-sclera injection of TA(20mg),and the control group received intravitreal injection of anti-VEGF drugs(0.5 mg I.The BCVA,average macular thickness,mean photosensitivity,and macular fluorescein leakageat week1,month 1 and months 3 after treatment.The test group comparedwith the control group.Results:Observe one: The test group compared with the control group 1 and the control group 2 respectively.1.The BCVA of test group increased at each time point after treatment.The BCVA of control group 1 increased slightly.The BCVA of test group compared with control group 1: P<0.05 at months 3.The BCVA of control group 2 decreased at each time point after treatment.The BCVA of test group compared with control group 2: P<0.05 at month 1 and months 3.2.The average macular thickness of test group decreased at each time point after treatment.The average macular thickness of control group 1 and control group 2 were improved at week 1 and month 1,but became worse at months 3.The average decrement rate of macular thickness of test groupcompared with control group 1 and control group 2 respectively,P<0.05 at month 1 and months 3.3.The mean photosensitivity of test group increased at month 1 andmonths 3.The mean photosensitivity of control group 1 increased slightly at month 1 andmonths 3;and control group 2 decreased obviously at month 1 and months 3.Observe two: The test group comparedwith the control group.1.Both the BCVA of test group and that of control group increased at each time point after treatment,and the two groups showed insignificant difference at each time point(P>0.05).2.The average macular thickness of test group and control group decreased at each time point after treatment.The test group compared with the control group,P>0.05 at each time point.3.The mean photosensitivity of test group increased at month 1 and months 3 after treatment.The control group increased obviously at month 1,and slightly rebound at months 3.The test group compared with the control group,P>0.05 at each time point.4.At months 3 after treatment,the macular fluorescein leakage of test groupand control group decreased at different degrees.Conclusion:1.With the use of an innovative self-made device,we take the lead in a controlled clinical trial: post-sclera injection of TA for the treatment of DME.It provide a new way for the treatment of DME2.Compared with the traditional ways(peribulbar injection of TA and laser treatment),post-sclera injection of TA has obvious advantages in DME improvement,photosensitivity improvement and BCVA recovery.3.Compared with the intravitreal injection of anti-VEGF drugs,post-sclera injection of TA achieved the similar efficacy,and post-sclera injection avoid the risk of intraocular injection.We firstly recognized that post-sclera injection of TA is an efficacy new method for the treatment of DME.4.As a long-acting corticosteroid,TA injection via post-sclera has obviously socio-conomic significance for DME patients,due to its low price. |
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