Abstract
PURPOSE: To evaluate the role of combined phacoemulsification and intravitreal injection of bevacizumab in prevention of postoperative diabetic macular edema (DME) in patients with no diabetic retinopathy or non-proliferative diabetic retinopathy (NPDR) and without macular edema. METHODS: In a prospective randomized clinical trial, 71 eyes from 71 diabetic patients with no diabetic retinopathy or mild NPDR and with central macular thickness (CMT) of less than 300 μm were enrolled and were randomized into two groups: combined phacoemulsification and intravitreal bevacizumab injection group and only phacoemulsification group. Our primary outcome measures included best corrected visual acuity (BCVA), CMT, and total macular volume (TMV) before and after (1 month and 3 months) the cataract surgery. RESULTS: The two groups did not show any significant difference in terms of baseline BCVA, age, CMT, stage of diabetic retinopathy. While the bevacizumab group showed lower CMT one month after the surgery compared to control group (267.3 ± 31.8 and 293.6 ± 53.7, respectively, P = 0.019), this difference did not remain significant 3 months after surgery (264.5 ± 21.9 and 291.4 ± 79.8, P = 0.089). The TMV and BCVA in the two groups showed no significant difference one month or 3 months after surgery. Considering our definition of post-cataract surgery diabetic macular edema (PME) in this study [CMT >300 μm using spectral domain optical coherence tomography (SD-OCT)], there was no significant difference between the incidence of PME at 1 month and at 3 months after surgery. CONCLUSIONS: Although the intravitreal injection of bevacizumab during phacoemulsification would result in decreased macular thickness in patients with no diabetic retinopathy or NPDR and without macular edema in the early postoperative period, this effect would no longer persistent at 3 months. In addition, the BCVA and TMV showed no significant difference between the two groups at any time during follow-up period.