Yoshihiro Takamura1, Eri Kubo, Yoshio Akagi. 1. Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Eiheiji-cho, Yoshida-gun, Fukui-ken, Japan.
Abstract
PURPOSE: To determine the feasibility and clinical effectiveness of intravitreal bevacizumab combined with cataract surgery for management of the postoperative increase of retinal thickness in patients with diabetic maculopathy. DESIGN: Prospective, randomized, masked cohort study. PARTICIPANTS: Forty-two eyes with diabetic macular edema (DME) of 42 patients with type 2 diabetes mellitus. METHODS: Patients were randomly assigned to receive either cataract surgery only (control; 21 eyes) or combined with intravitreal injection of 1.25 mg bevacizumab (21 eyes). Efficacy measures included best-corrected visual acuity (BCVA) testing, optical coherence tomography (OCT), and ophthalmoscopic examination. MAIN OUTCOME MEASURES: Retinal thickness (RT) on OCT and BCVA were measured at baseline and 1 and 3 months after surgery. RESULTS: There were no significant differences in RT, BCVA, severity of cataract, or systemic condition between the control and bevacizumab groups at the baseline. One and 3 months after surgery, the control group showed a significant increase in RT, whereas the bevacizumab group showed a significant decrease. Although postoperatively the eyes in both groups showed a significant improvement of BCVA, bevacizumab-treated eyes showed significantly better results (mean logarithm of the minimum angle of resolution, 0.38) than the control group (0.51) at month 3. There was a significant relationship between RT and visual acuity (VA) postoperatively in the control (P = 0.0001) and bevacizumab (P = 0.0141) groups. No systemic or ocular adverse events were observed. CONCLUSIONS: Short-term results suggest that intravitreal bevacizumab has the potential not only to prevent the increase in RT, but also reduce the RT of eyes with DME after cataract surgery. Further improvement of VA in bevacizumab-treated eyes may be dependent on a reduction in central RT. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.
RCT Entities:
PURPOSE: To determine the feasibility and clinical effectiveness of intravitreal bevacizumab combined with cataract surgery for management of the postoperative increase of retinal thickness in patients with diabetic maculopathy. DESIGN: Prospective, randomized, masked cohort study. PARTICIPANTS: Forty-two eyes with diabetic macular edema (DME) of 42 patients with type 2 diabetes mellitus. METHODS:Patients were randomly assigned to receive either cataract surgery only (control; 21 eyes) or combined with intravitreal injection of 1.25 mg bevacizumab (21 eyes). Efficacy measures included best-corrected visual acuity (BCVA) testing, optical coherence tomography (OCT), and ophthalmoscopic examination. MAIN OUTCOME MEASURES: Retinal thickness (RT) on OCT and BCVA were measured at baseline and 1 and 3 months after surgery. RESULTS: There were no significant differences in RT, BCVA, severity of cataract, or systemic condition between the control and bevacizumab groups at the baseline. One and 3 months after surgery, the control group showed a significant increase in RT, whereas the bevacizumab group showed a significant decrease. Although postoperatively the eyes in both groups showed a significant improvement of BCVA, bevacizumab-treated eyes showed significantly better results (mean logarithm of the minimum angle of resolution, 0.38) than the control group (0.51) at month 3. There was a significant relationship between RT and visual acuity (VA) postoperatively in the control (P = 0.0001) and bevacizumab (P = 0.0141) groups. No systemic or ocular adverse events were observed. CONCLUSIONS: Short-term results suggest that intravitreal bevacizumab has the potential not only to prevent the increase in RT, but also reduce the RT of eyes with DME after cataract surgery. Further improvement of VA in bevacizumab-treated eyes may be dependent on a reduction in central RT. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.
Authors: Michael Stur; Stefan Egger; Anton Haas; Gerhard Kieselbach; Stefan Mennel; Reinhard Michl; Michael Roden; Ulrike Stolba; Andreas Wedrich Journal: Wien Klin Wochenschr Date: 2012-12 Impact factor: 1.704