Comparison of a preservative-free non-steroidal anti-Inflammatory drug and preservative-free corticosteroid after uncomplicated cataract Surgery: A multicenter, randomized, evaluator-blinded clinical trial (Free NACC study).

Abstract

PURPOSE\nThis study aimed to compare the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) and steroidal eye drops for inflammation management after cataract surgery using slit lamp indicators.\n\n\nSETTING\nEleven eye centers in South Korea.\n\n\nDESIGN\nA randomized prospective multicenter study with a blinded evaluator.\n\n\nMETHOD\nIn 125 patients undergoing cataract surgery, 0.1% bromfenac sodium hydratewas applied twice a day in one eye while the other eye was treated with 0.1% fluorometholone; 4 times a day for 4 weeks after surgery. The primary efficacy outcome was the presence of anterior chamber cells and flare at 1 week after surgery. Anterior chamber cells and flare at 4 and 8 weeks, best corrected visual acuity, central corneal thickness, conjunctival hyperemia, dry eye parameters, foveal thickness, and ocular and visual discomfort were evaluated as secondary outcomes.\n\n\nRESULTS\nAt week 1, residual anterior chamber inflammation was not significantly different between the groups (-1.03±1.27vs.-0.95±1.24, p=0.4850). However, the NSAID group recovered from conjunctival hyperemia more rapidly than the steroid group (0.30±0.52vs.0.44±0.81, p=0.0144 at week 1). The increase in central corneal thickness in the NSAID group was less than that in the steroid group 1 week after surgery (7.87±22.46vs.29.47±46.60μm, p<0.0001). The change in foveal thickness in the NSAID group was significantly less than that in the steroid group (18.11±68.19vs.22.25±42.37μm, p=0.0002). Lower levels of postoperative ocular and visual discomfort were reported in the NSAID group than in the steroid group under treatment.\n\n\nCONCLUSION\nPreservative-free bromfenac was as effective as preservative-free fluorometholone eye drops in anterior chamber inflammation control and showed better signs and symptoms after cataract surgery.