Two doses of difluprednate 0.05% nanoemulsion (DIFL) per day is noninferior to the conventional 4 doses of prednisolone 1% + phenylephrine hydrochloride 0.12% suspension (PRED) at treating inflammation following cataract surgery, according to research published in the Journal of Cataract & Refractive Surgery.
Researchers suggest the main benefit of using DIFL in favor of PRED is the decreased dosage frequency, which they expect to increase compliance.
The goal of this randomized prospective study was to compare the effectiveness of 2 doses per day of DIFL vs 4 doses per day of PRED for preventing inflammation following cataract surgery. Participants received surgery between March 2019 and July 2020 at 4 private ophthalmologic centers in Argentina. They were randomly assigned to the DIFL or PRED cohorts and began receiving treatment the day before surgery, concluding 28 days after surgery. Outcome measurements were taken at baseline and days 1, 4, and 28. Noninferior anti-inflammatory efficacy was determined using the difference in central corneal thickness (CCT) between baseline and day 4 (with ≥17 µm qualifying as “noninferior”).
Secondary outcome measures included cell and flare, corrected distance visual acuity (CDVA), endothelial cell count, central macular thickness, and intraocular pressure (IOP).
A total of 225 participants completed this study. There was no statistically significant difference between DIFL and PRED treatments (P =.523), with CCT within 17 μm between treatments (95% CI -2.78 μm to 14.84 μm), signaling noninferior anti-inflammatory efficacy of DIFL. No statistically significant differences were found in total anterior chamber clearance (P <.05), CDVA (P =.455), endothelial cell count (P =.811), OCT central macular thickness (P =.869), and intraocular pressure outcome (P =.316).
DIFL is as effective as PRED at managing inflammation following cataract surgery, according to the study. In comparison with PRED, DIFL requires less frequent dosing, has a higher bioavailability, and does not contain benzalkonium chloride in the solution.
This study is limited by its lack of an objective measure of anterior chamber inflammation and the limited drug availability in Argentina, forcing researchers to use prednisolone, which could negatively affect the results.
Valvecchia G, Kaufer R, Ferroni C, et al. Difluprednate 0.05% twice a day vs prednisolone acetate 1% 4 times a day for cataract postsurgical inflammation treatment: noninferiority trial. J Cataract Refract Surg. 2022;48(7):753–758. doi:10.1097/j.jcrs.0000000000000863.