Evaluation Of Ex-PRESS Implantation Combined With Phacoemulsification In Primary Angle-closure Glaucoma:A Randomized Controlled Trial

PURPOSETo compare the efficacy and safety of Ex-PRESS mini glaucoma shunt implantation combined with phacoemulsification with phacotrabeculectomy for primary angle-closure glaucoma(PACG)combined with cataract.METHODSThis was a prospective randomized controlled trial.Patients with PACG combined with cataract who met the inclusion criteria were included in this study from January2015 to August 2017.Fifty subjects were randomly divided into two groups according to different surgeries.They were phacoemulsification combined with Ex-PRESS implantation group(the Phaco Ex-PRESS group)and phacoemulsification combined with trabeculectomy the Phaco-Trab group).Both groups were followed postoperatively for 12 months.RESULTSMean intraocular pressure(IOP)before operation was 26.44±12.26 mm Hg vs27.19±12.73 mm Hg for the Phaco Ex-PRESS group vs the Phaco-Trab group,respectively.There was no significant difference between the two groups(t=0.212,p=0.833).Mean IOP at 12 months after surgery was 15.80±6.04 mm Hg vs 15.47±3.20 mm Hg,which was significantly reduced comparing with baseline in both groups(t=2.490,p=0.026 vs t=3.261,p=0.005).There was no significant difference between the two groups(t=-0.169,p=0.846).The cumulative complete success rate at 12months was 70.8%for the Phaco Ex-PRESS group and 90.6%for the Phaco-Trab group(p=0.071).The mean preoperative visual acuity(log MAR)of the two groups was 0.52(0.19,1.44)vs 0.40(0.22,0.95),and there was no significant difference between the two groups(U=296.5,p=0.944).Visual acuity at 12 months was0.10(0.01,0.30)vs 0.22(0.10,0.40),and there was no statistical difference between the two groups(U=129.0,p=0.133).The average preoperative cup to disk ratio in the two groups was 0.73±0.22 vs 0.75±0.18(p=0.747),and 0.80±0.17 vs 0.80±0.14(p=1.000)at 12months.There was no statistical difference between the two groups(p>0.05).There were fewer intraoperative complications in the Phaco Ex-PRESS group than in the Phaco-Trab group(?~2=8.000,p=0.005).There were no serious complications affecting visual function in both groups.Loss of endothelial cells was observed in both groups but there was no statistical difference between the two groups(p>0.05).CONCLUSIONSEx-PRESS implantation combined with phacoemulsification is safe and effective for patients with PACG combined with cataract.No differences were found in mean IOP,complete success rates and visual acuity between Ex-PRESS implantation combined with phacoemulsification and phacoemulsification combined with trabeculectomy,and the former one led to fewer complications.