Randomized Controlled Trial Comparing Nepafenac, Ketorolac, and Placebo in Preventing Macular Edema After Uncomplicated Cataract Extraction: 3-Year Follow-up
Purpose
To evaluate the efficacy of prophylactic ketorolac 0.5% versus nepafenac 0.1% versus placebo on macular volume 3 years after uncomplicated phacoemulsification cataract extraction.
Methods
This is a prospective placebo-controlled parallel assignment double-blind randomized clinical trial. Patients were randomized for one month to placebo (n=15), ketorolac 0.5% (n=15), or nepafenac 0.1% (n=15) dosed QID starting one day before surgery. Spectral-domain ocular coherence tomography (OCT) scans were performed at baseline and 3 years after surgery. Main outcome measures include change in OCT central subfield thickness (CST), macular cube volume (VOL), and average macular cube thickness (AVG).
Results
In all 3 groups, OCT CST, VOL and AVG returned to baseline measurements at 3 years follow-up. There was no difference between medication and placebo. 1 month data had shown a significant difference in cube volume between ketorolac and nepafenac. This trend was not reproduced at long term follow-up. Analysis of means of differences reveals no statistically significant difference for the OCT macular cube values of CST (p=0.21), AVG (p=0.31), and VOL (p=0.71) among the three study groups.
Conclusion
At three years after uncomplicated phacoemulsification cataract extraction, we found no difference in macular volume between placebo, ketorolac, and nepafenac. For patients without risk factors for macular edema, prophylactic use of topical NSAIDs is not recommended.