PURPOSE: To compare the anti-inflammatory efficacy and subjective tolerability of preservative-free and preserved diclofenac 0.1% and preserved ketorolac 0.5% eye drops for prophylaxis and management of inflammation after cataract surgery. DESIGN: Prospective, randomized, investigator-masked, parallel-group, comparative clinical trial. METHODS:One hundred two patients who underwent small-incision phacoemulsification cataract surgery in an institutional setting were assigned randomly to receive preservative-free diclofenac sodium 0.1% (Voltaren ophtha SDU; Novartis Pharma), preserved diclofenac sodium 0.1% (Voltaren ophtha; Novartis Pharma), or preserved ketorolac tromethamine 0.5% (Acular; Pharm Allergan) eyedrops 4 times daily for 4 weeks after surgery. During the 1-month follow-up, anterior chamber flare and mean foveal thickness were evaluated for objective comparison of the anti-inflammatory effect. Ocular tolerability was assessed by observer-based grading of conjunctival hyperemia and ocular discomfort, as well as obtaining subjective ratings of ocular tolerability on a visual analog scale. Distance and near visual acuity and intraocular pressure served as safety measures. RESULTS: All 3 formulations demonstrated equal anti-inflammatory efficacy as measured by reduction of anterior chamber flare after surgery and prevention of postoperative macular edema. Patients treated with preservative-free diclofenac eyedrops reported significantly better subjective tolerability values (P = .001), were classified as having less ocular discomfort (P < .001), and experienced earlier reduction of postoperative conjunctival hyperemia (P = .029). CONCLUSIONS:Anti-inflammatory efficacy was comparable for all 3 agents. However, preservative-free diclofenac 0.1% eyedrops exhibited a significantly better postoperative subjective and objective tolerability when compared with preserved eyedrops containing ketorolac or diclofenac. Copyright 2010 Elsevier Inc. All rights reserved.
RCT Entities:
PURPOSE: To compare the anti-inflammatory efficacy and subjective tolerability of preservative-free and preserved diclofenac 0.1% and preserved ketorolac 0.5% eye drops for prophylaxis and management of inflammation after cataract surgery. DESIGN: Prospective, randomized, investigator-masked, parallel-group, comparative clinical trial. METHODS: One hundred two patients who underwent small-incision phacoemulsification cataract surgery in an institutional setting were assigned randomly to receive preservative-free diclofenac sodium 0.1% (Voltaren ophtha SDU; Novartis Pharma), preserved diclofenac sodium 0.1% (Voltaren ophtha; Novartis Pharma), or preserved ketorolac tromethamine 0.5% (Acular; Pharm Allergan) eyedrops 4 times daily for 4 weeks after surgery. During the 1-month follow-up, anterior chamber flare and mean foveal thickness were evaluated for objective comparison of the anti-inflammatory effect. Ocular tolerability was assessed by observer-based grading of conjunctival hyperemia and ocular discomfort, as well as obtaining subjective ratings of ocular tolerability on a visual analog scale. Distance and near visual acuity and intraocular pressure served as safety measures. RESULTS:All 3 formulations demonstrated equal anti-inflammatory efficacy as measured by reduction of anterior chamber flare after surgery and prevention of postoperative macular edema. Patients treated with preservative-free diclofenac eyedrops reported significantly better subjective tolerability values (P = .001), were classified as having less ocular discomfort (P < .001), and experienced earlier reduction of postoperative conjunctival hyperemia (P = .029). CONCLUSIONS: Anti-inflammatory efficacy was comparable for all 3 agents. However, preservative-free diclofenac 0.1% eyedrops exhibited a significantly better postoperative subjective and objective tolerability when compared with preserved eyedrops containing ketorolac or diclofenac. Copyright 2010 Elsevier Inc. All rights reserved.