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Purpose To establish if Difluprednate 0.05% nanoemulsion (DIFL) twice a day (BID) is as effective as Prednisolone acetate 1% + Phenylephrine hydrochloride 0.12% suspension (PRED) four times a day (QID) on postsurgical inflammation treatment. Setting 4 private Argentine ophthalmological centers. Design Non-inferiority, prospective, multicenter, double-blind, randomized, parallel-group, comparative trial. Methods A total of 259 patients who underwent phacoemulsification randomly received DIFL or PRED starting the day before surgery and continuing for 28 days. The primary endpoint was central corneal thickness. Non-inferior anti-inflammatory efficacy was considered if the difference of corneal thickness between baseline and Day 4 did not differ beyond 17 µm between treatments. Secondary endpoints were cell & flare, corrected distance visual acuity (CDVA), endothelial cell count, OCT-central macular thickness, and intraocular pressure (IOP). All outcomes were evaluated at baseline, day 1, 4, and 28 after surgery. Results 225 patients finished the study. The difference in corneal thickness at baseline and Day 4 did not differ beyond 17 µm between treatments (IC95% -2.78µm - 14,84 µm), with no statistically significant difference between treatments (p = 0.523). There were not statistically significant differences between groups on total anterior chamber clearance at any study time (p > 0.05). No statistically significant differences were reported between treatments in CDVA (p = 0.455), endothelial cell count (p = 0.811), OCT-central macular thickness (p = 0.869), and in intraocular pressure outcome (p = 0.316). Conclusions Difluprednate administered BID is at least as effective as Prednisolone acetate administered QID on inflammatory treatment following cataract surgery.

Purpose To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye. Setting Multicenter study at 8 investigative sites. Design Prospective randomized parallel-group patient-masked 2-arm study. Methods This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR. Results In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups. Conclusion Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).