BACKGROUND AND OBJECTIVES: The use of topical anesthesia in cataract surgeries has been increasing, especially after the development of phacoemulsification. The objective of this study was to evaluate the efficacy of topical anesthesia associated with sedation for cataract extraction by phacoemulsification. METHODS: A prospective study was conducted with 312 patients, ASA I and II, ages 41 to 89 years. Phacoemulsification was performed under topical anesthesia (5 minutes before surgery, by dripping 0.5% proximetacaine) associated with sedation (intravenous midazolam, 1 mg, administered 15 minutes before the surgery). Intravenous bolus of alfentanil, 125 microg, were administered under demand. Parameters, such as intraoperative pain, consumption of alfentanil, side effects, recovery time, and level of patient satisfaction were analyzed. RESULTS: In the intraoperative period, 8 (2.6%) cases of bradycardia, 4 (1.3%) of epithelial edema, 2 (0.65%) of nausea, and 2 (0.65%) ruptures of the posterior capsule were observed. In the postoperative period, 15 (4.8%) cases of nausea, 6 (1.9%) cases of dizziness, 2 (0.65%) of vomiting, and 1 (0.32%) case of bradycardia were observed. The mean time of postoperative recovery was 21.77 minutes. Consumption of alfentanil varied from 125 microg to 1250 microg, with a mean consumption of 537 microg. Three hundred (96.2%) patients classified the technique as good and 12 (3.8%), as regular. Forty-two patients complained of pain sometime during surgery, and 4 (1.3%) patients said that if they needed another phacoemulsification, they would not like to undergo the same anesthetic technique. CONCLUSIONS: In this study, topical anesthesia with sedation of patients undergoing cataract removal by phacoemulsification demonstrated to be effective, easy to apply, and had a very low incidence of complications.