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Michelle Abou-Jaoude, William Trattler, Carlos Buznego, John Hovanesian, Bonnie Henderson; Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification. Invest. Ophthalmol. Vis. Sci. 2014;55(13):2542.
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The study was a prospective, multicenter comparative trial evaluating the effectiveness of Loteprednol 0.5% vs. Prednisilone Acetate 1% for patients undergoing cataract surgery.
The study was conducted as a prospective, masked evaluation of 73 cataract surgery patients receiving either Loteprednol 0.5% or brand-name Pred Forte (Prednisolone Acetate 1%). Patients were included if they completed at least one follow-up visit. The patients were prescribed either loteprednol or prednisilone acetate, along with brand name bromfenac BID and besivance 0.6% BID starting 3 days before surgery. The topical steroid and a topical NSAID were continued for 4 weeks post-Op. Besifloxacin was continued for 10 days post-Op. Outcomes measured included CCT, UCVA, BCVA, MOCT, AC scores, and IOP at 1 day, 1 week, and 1 month postoperatively.
At baseline 36 subjects were enrolled in Group A, 33% male, average age of 69. 37 subjects were enrolled in Group B, 41% male, average age of 66. There were not significant differences between Group A and Group B in the change at one month from preop in MOCT (p=0.07), UCVA (p=0.35), BCVA (p=0.48), IOP (p=0.87), or CCT (p=0.08). At one day, one week and one month 8.3%, 16.7%, and 61% of subjects had 0 cells and 0 flare in Group A while 13%, 27.8%, and 72% of subjects had 0 cells and 0 flare in Group B.
Groups A and B were statistically comparable at baseline and in MOCT, UCVA, BCVA, IOP, and CCT at one month post-op from baseline. Group B had a higher percentage of eyes with 0% combined cells/flare. 100% of patients at one month in both groups had BCVAs of 20/30 or higher.
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