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D.S. Rho, S.M. Soll, B.J. Markovitz; Bromfenac 0.09% versus Diclofenac Sodium 0.1% versus Ketorolac Tromethamine 0.5% in the Treatment of Acute Pseudophakic Cystoid Macular Edema . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5211.
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To compare the efficacy of a new topical non–steroidal anti–inflammatory drug (NSAID), bromfenac 0.09% ophthalmic solution (B), with two topical NSAIDs with known efficacy in the treatment of pseudophakic cystoid macular edema (CME), diclofenac sodium 0.1% ophthalmic solution (D) and ketorolac tromethamine 0.5% ophthalmic solution (K).
52 eyes with acute pseudophakic CME of less than one year duration after uncomplicated cataract surgery with phacoemulsification and posterior chamber intraocular lens implantation were randomized to treatment of the CME affected eye with one of three regimens: B one drop twice daily, D one drop four times daily, or K one drop four times daily. 18 patients were treated with B, 18 with D, and 16 with K. Visual acuity (VA) was measured with standardized ETDRS charts and recorded in ETDRS letters. Patients were examined monthly for three months. Compliance was assessed by history and examination of the medication bottles. Exclusion criteria included: intra–operative vitreous loss or iris trauma, CME greater than one year duration, pre–existing macular pathology, retinal vasculopathy, prior ipsilateral ophthalmic surgery, and uveitis history.
All patients completed the study and were compliant with the prescribed regimens. The B group mean age was 74.9 ± 8.9 years, with mean initial VA 20/81.4 ± 59.5 and 29.2 ± 14.1 ETDRS letters. The B group mean 3 month VA was 20/39.2 ± 18.5 and 40.5 ± 8.3 ETDRS letters, with mean visual gain of 11.8 ± 9.1 ETDRS letters. The D group mean age was 71.5 ± 4.4 years, with mean initial VA 20/173 ± 94.0 and 9.1 ± 4.9 ETDRS letters. The D group mean 3 month VA was 20/107.4 ± 45.7 and 20.6 ± 9.7 ETDRS letters, with mean visual gain of 11.5 ± 7.3 ETDRS letters. The K group mean age was 70.2 ± 5.0 years, with mean initial VA 20/160 ± 75.8 and 10.0 ± 6.1 ETDRS letters. The K group mean 3 month VA was 20/107.6 ± 45.5 and 20.6 ± 10.1 ETDRS letters, with mean visual gain of 10.6 ± 8.1 ETDRS letters. Treatment for 3 months with B, D or K each produced statistically significant gains in EDTRS letters seen (B, p < 0.001; D, p < 0.001; K, p < 0.001) and VA (B, p = 0.001; D, p < 0.001; K, p < 0.001). Comparing ETDRS letters gained after 3 months between treatment groups was not statistically significant: B vs. D (p = 0.79), D vs. K (p = 0.73) and B vs. K (p = 0.70).
B, D and K each achieved statistically significant visual improvement after three months treatment. B dosed twice daily for 3 months was statistically as effective as D or K dosed four times daily for 3 months.
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