| ObjectiveTo observe the clinical effect which are intraoperative and postoperative follow-up situations of microincision vitreoretinal surgery (VRS) assisted with intravitreal anti-vascular endothelial growth factor (VEGF) monoclonal antibody ranibizumab (IVR) in severe proliferative diabetic retinopathy (PDR). To investigate the adjuvant significance of preoperative IVR to VRS and the recovery effect of postoperative,then provides a adjuvant method for the VRS treatment and clinical basis for severe PDR.Methods1. This is a prospective non-randomized controlled clinical study. A total of81patients (100eyes) with severe PDR diagnosed were enrolled. We informed all patients for IVR’s therapeutic purposes and risks,then they should decided whether accepeted IVR before VRS treatment. They divided into IVR group (41patients,50eyes) and control group (40patients,50eyes) based on whether accepeted IVR preoperative. IVR group patients received an intravitreal injection of0.05ml ranibizumab solution (10mg/ml) first, and3or4days later they received23G microincision VRS. Control group patients only received23G microincision VRS.2. We comparative analysis the intraoperative outcomes of the two groups’PDR patients,such as operative time、the number of neovascular bleeding、the number of bleeding degree (mild and severe)、coagulation times、the number of switching devices、the incidence of iatrogenic retinal breaks、the retinal incision rates.Also,we comparative analysis the postoperative statistical results,such as the VH incidence at1week、1month、3months、6months, the logarithm of the minimum angle of best corrected visual acuity、intraocular pressure、central retinal thickness、retinal detachment and post-operative complications.3. The results were input the SPSS19.0statistical software. After normality test and homogeneity of variance test, measurement data were expressed as mean±standard deviation (x±s) and the t test was implemented. P<0.05(bilateral) is a statistically significant difference. Segment information were expressed as n (%) and χ2test was implemented, P<0.05(bilateral) is a statistically significant difference. The correlation between the two variables were implemented by Pearson correlation coefficient analysis.Results1. The basic case of IVR group and control group before surgeryThe gender, age, duration of diabetes, history of hypertension, aspirin history, smoking history, PDR installments, LogMAR BCVA, intraocular pressure, complexityscore (CS) of the two groups before surgery have no statistically significant difference (P>0.05).2. The intraoperative statistical results of the IVR group and control groupThe patients of IVR group did not occur topical and systemic adverse reactions associated with the drugs. The average operative time of IVR group and control group was respectively (87.43±29.34),(100.86±17.21) min, the difference was statistically significant (t=-2.34, P<0.05). In IVR group and the control group, the average number of intraoperative neovascular bleeding was respectively (0.66±0.72),(1.44±1.23), and the difference was statistically significant (t=-4.13, P<0.05). In IVR group the mild and severe bleeding respectively accounted for54.5%,45.5%, while in the control group, the mild and severe bleeding respectively accounted for37.8%,62.2%, when comparing the the degree of bleeding constitute of the two groups, the difference was not statistically significant (χ2=2.70, P>0.05). IVR group and the control group with an average intraoperative coagulation times were respetively (0.30±0.58),(0.82±0.94) and the difference was statistically significant (r=-3.33, P<0.05). The average number of switching devices of the IVR group and the control group were respectively15.28±5.35,23.47±7.32, the difference was statistically significant (t=4.56, P<0.05). The incidence of iatrogenic retinal breaks of the IVR group and the control group were respectively2%,16%, the difference was statistically significant (χ2=4.40, P<0.05). The intraoperative retinal incision rates were respctively14%,32%, and the difference was statistically significant (χ2=4.57, P<0.05).3. The postoperative statistical results of the IVR group and control group 1week after surgery The VH incidence in IVR group was lower than in the control group, the difference was statistically significant (χ2=4.34, P<0.05), and the different levels of the VH incidence were respetively6.0%,4.0%,0.0%,while in the control group was12.0%,10.0%,4.0%.1month after surgery, VH incidence in IVR group was lower than in the control group, the difference was statistically significant (χ2=5.98, P<0.05), and the different levels of VH incidence was respectively2.0%,0.0%,0.0%,while in the control group was respectively8.0%,6.0%,2.0%.3months after surgery, the incidence of postoperative VH of the two groups was not statistically significant difference (χ2=3.10, P>0.05), IVR group not has VH, the control group was4.0%,2.0%,0.0%. After6months, the incidence of postoperative VH of the IVR group and the control group was not statistically significant difference (χ21.01,P>0.05).The mean logMAR BCVA of the IVR group and the control group after surgery was respectively0.81±0.40and1.05±0.42, when compared with those before surgery both improved. The mean postoperative logMAR BCVA in IVR group was better than the control group, the difference was statistically significant (t=-2.36, P<0.05). Compared with the preoperative visual acuity of the IVR group,43eyes (86.0%) improved after surgery, unchanged vision in6eyes (12.0%), decreased vision in one eye (2.0%); compared with the preoperative visual acuity in the control group,32eyes (64.0%) improved after surgery, visual unchanged in13eyes (26.0%), decreased vision in one eye (10.0%). Comparing the improve vision of the two groups, the difference was statistically significant (χ2=6.86, P<0.05).At the last follow-up, the mean IOP of the IVR group was (14.8±3.3) mmHg,when compared with the preoperative IOP, the difference was not statistically significant (t=0.97, P>0.05). The mean IOP of the crontrol group was (15.6±3.2) mmHg, when compared with the mean preoperative IOP, the difference was not statistically significant (t=1.08, P>0.05). Compared the postoperative IOP of the two group, the difference was not statistically significant (t=-0.85, P>0.05).The average CRT of the IVR group and control group after surgery was respectively (295.7±80.5) and (343.6±84.7) μm,compared the average CRT of the two groups, the difference was statistically significant (t=-2.56, P<0.05). The retinal reattachment rate of the IVR group and the control group after surgery was respectively97.1%,94.3%, the difference between the two groups was not statistically significant (χ2=0.34, P>0.05). The incidence of transient ocular hypertension in IVR group and control group was respectively16.0%,34.0%, when compared the two groups the difference was statistically significant (χ2=4.07, P <0.05). The epiretinal membrane, neovascular glaucoma and other complications in IVR group and the control group had no statistically significant difference (χ2=0.33,0.51, P>0.05).Conclusion1. The preoperative IVR which was performed3-4days before VRS for severe PDR is safe and effective in the short term, can quickly induce severe PDR neovascularization back in the short-term. Under the principle of voluntary and informed, IVR assisted23G microincision VRS for severe PDR is an effective choice of treatment.2. IVR assisted23G microincision VRS treatment for severe PDR can effectively reduce intraoperative bleeding, reduce the difficulty of VRS, and reduce the incidence of surgical complications.3. IVR assisted23G microincision VRS treatment for severe PDR can effectively reduce the incidence of early postoperative VH, reduce the incidence of postoperative transient ocular hypertension.4.23G microincision VRS treatment for severe PDR can improve visual acuity.IVR assisted VRS23G microincision VRS treatment for severe PDR can effectively reduce postoperative CRT, to help further improvement of visual acuity.5. A small part patients of IVR group is still diabetic macular edema after surgey, and the postoperative effects of PDR with RVO are still limited that vision are difficult to recover.Therefore,the value of IVR before surgery and whether IVR after surgery and other issues need further clinical studies. |
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