Abstract
Purpose: :
Study effect of nepafenac 0.1% (Alcon, Inc. Ft. Worth, TX) used 1 month postop on macular thickness following uncomplicated cataract surgery in pts at low risk of post operative cystoid macular edema (CME)
Methods: :
Prospective, randomized controlled clinical trial. Randomized to standard care (s) (Vigamox x1 week, topical steroid x1 month); standard care + nepafenac (n), 3x daily x1 month postop. All pts received nepafenac q5min x3, immediately prior to surgery. Exclusion criteria: diabetes, uveitis, macular deg, abnormal preop OCT. Surgeon KLC, bimanual technique, Infiniti (Alcon, Ft. Worth, TX). Preop and 2mo postop OCT scans (Carl Zeiss Meditec, Inc. San Francisco, CA) and ETDRS vision measured. Cataracts graded: LOCS III. Phaco metrics recorded. Between-group comp: Wilcoxon rank sum test & Pearson chi square test. Within-subject pre-postop comp: Paired t-test, 95% confidence
Results: :
56 pts, 24 (n) and 32 (s). No difference in baseline characteristics: (mean age (n)74.79 ± 9.44, (s)71.03 ± 7.09; pre-op ETDRS letters (n)40.00 ± 11.67, (s)39.41 ± 9.59; average central 1mm macular thickness (CMT) (µm) (n)39.41 ± 9.59, (s)214.5 ± 26.91; foveal thickness (FT) (µm) (n)190.1 ± 38.98, (s)190.4 ± 32.18; and macular volume (MV) (mm3) (n) 6.61 ± 0.41, (s) 6.60 ± 0.49). More dense cataracts in nepafenac group (nuclear color (n)4.03 ± 0.91, (s)3.65 ± 0.88) not significant. More phaco time (PT)(sec) ((n)14.44 ± 9.57, (s)9.70 ± 8.37, P=.0300) and effective phaco time (EPT)(sec) (n)6.96 ± 4.77, (s)4.64 ± 4.18, P=0.0257) in the nepafenac group. No difference in average phaco power (%) ((n)47.35 ± 3.07, (s)45.57 ± 6.04) or average power in foot position 3 (%) ((n)6.35 ± 1.85, (s)5.32 ± 2.35). No difference in postop ETDRS letters ((n)55.38 ± 5.68, (s)54.90 ± 5.25). No difference in postop CMT (n)221.5 ± 37.47, (s)218.2 ± 29.11; FT (n)193 ± 42.49, (s)188.1 ± 32.76; or MV (n)6.74 ± 0.35, (s)6.65 ± 0.79. No difference in change in CMT (n) 5.75 ± 12.63, (s)3.69 ± 11.89; FT (n)3.46 ± 18.54, (s)-2.34 ± 23.33; or MV (n)0.12 ± 0.20, (s).0.05 ± 0.56. No adverse events.
Conclusions: :
Risk of CME following routine cataract surgery is low. Demonstrating a treatment effect was not possible in this small study. Thorough randomization was not demonstrated. PT and EPT were significantly greater in the nepafenac group. Despite this, both groups had no change in macular thickness and had good visual outcomes. If phaco energy predisposes to CME, then nepafenac may be preventative. Pre/Postop use of nepafenac may be sufficient to prevent postop macular thickening. More pts are needed for stronger conclusions to be made. Future study of nepafenac in pts at higher risk of CME is indicated.
Clinical Trial: :
www.clinicaltrials.gov NCT00494494
Keywords: cataract • edema • drug toxicity/drug effects