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M. W. Aschbrenner, K. C. Mathys, K. L. Cohen; Do Biological Parameters and Phaco Metrics Affect OCT Measured CMT With and Without Nepafenac 0.1% Treatment?. Invest. Ophthalmol. Vis. Sci. 2008;49(13):389.
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Study relationship of biological parameters surgical metrics, and nepafenac 0.1% treatment used for 1 month post operatively on OCT (Carl Zeiss Meditec) measured CMT.
Prospective, randomized controlled clinical trial. Eligible patients randomized to receive standard care (s) following cataract surgery (Vigamox x1 week, prednisolone 1% x1 month) or standard care + nepafenac (n) 3 times daily x1 month post-op. All patients received pre-op nepafenac q5min x3, prior to surgery. Exclusion criteria: diabetes, uveitis, macular degeneration, abnormal pre-op OCT. Surgeon KLC, bimanual, microincision phaco, Infiniti. Measurements: Pre-op cataracts LOCS III. Pre-op and 2 mo post-op OCT, ETDRS vision. Phaco metrics (phaco time (PT), average phaco power (PP), average power in foot position 3 (APFP3) and effective phaco time (EPT)). Between-group comparisons: Wilcoxon rank sum test, Pearson chi square test and Pearson product-moment correlation. Within-subject pre-post surgery comparison: Paired t-test, 95% confidence level.
56 eyes analyzed 24 (n) 32(s); no adverse events. No difference in baseline: mean age, pre-op ETDRS, or average central 1mm macular thickness (CMT). More dense cataracts in nepafenac group (nuclear color (NC)) (n)4.03 ± 0.91, (s)3.65 ± 0.88 but not significant. More PT (n)14.44 ± 9.57, (s)9.70 ± 8.37, p=.0300 and EPT (n)6.96 ± 4.77, (s)4.64 ± 4.18, p=0.0257 in the nepafenac group. No difference in APFP3. No difference in post-op ETDRS. Positive correlations in combined (n) and (s) groups between post-op CMT and: NC 0.2878 p=0.0349, (nuclear opalescence (NO)) 0.2793 p=0.0408, PT 0.4529 p=0.0005, APFP3 0.3544 p=0.0074 and EPT 0.4438 p=0.0006. Positive correlations in (n) groups between CMT and: NC 0.4357 p=0.0377, PT 0.5936 p=0.0022, APFP3 0.5063 p=0.0116 and EPT 0.5772 p=0.0031 with no correlation for NO 0.4065 p=0.543. No correlations in (s) groups between CMT and: NC, NO, PT, APFP3 and EPT.
Combined and (n) groups showed that NC, PT, APFP3 and EPT were correlated with post-op CMT. NO was also correlated in combined groups. There were no correlations in (s) group between biological and surgical metrics and CMT. However, in this small study, randomization between groups was not attained as the (n) group had more PT and EPT. As the numbers of participants continues to increase, we hypothesize that the (s) group will appear similar to the (n) group. This study does show that increased PT, APFP3 and EPT are correlated with post-op CMT on OCT, which does not appear to be decreased with nepafenac treatment in this sample size of low risk patients.
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