Abstract
Purpose: :
To determine the effect of topical ketorolac 0.4% on retinal thickness, as measured by Optical Coherence Tomography (OCT), in patients undergoing routine cataract surgery.
Methods: :
Twenty one patients were randomized to receive either ketorolac tromethamine 0.4% QID (ACULAR LS) or no NSAID treatment (control) 1 day prior to planned surgery as well as for one month post operatively. All patients received topical moxifloxacin 0.5% (VIGAMOX®) for one week QID and topical prednisolone acetate 1% (ECONOPRED PLUS®) with a weekly taper per routine pre and post operatively. Routine pre and postoperative measurements included vision (UCVA, BCVA) slit lamp exam, IOP, and dilated retinal exam. Each patient underwent OCT prior to surgery and at 1–2 weeks, (+/– 4 days) one month (+/– 10 days) and three months (+/– 14 days) post operatively in order to assess retinal thickness. The OCT evaluator was masked as to the treatment assignment. A Wilcoxon test was used for between–group comparisons. A paired–comparison t–test was used to compare the within–patient changes from pre–op to post–op visits within each group.
Results: :
The mean (±SD) pre–op retinal thickness was 209.50 µm (± 10.38) in the Acular LS group and 205.25 µm (± 17.74) in the no NSAID group (P = 0.42). There were significant (P < 0.05) increases in retinal thickness in both treatment groups compared to baseline retinal thickness measurements. These were not significantly different between the treatment groups. At the 30–day time point, 55.6% of ketorolac 0.4% patients (n = 9) and 42.9% of the no NSAID treatment patients (n = 7) had an increase greater than 10% as compared to pre–op measurement (P = 0.63). 3–month OCT data are pending.
Conclusions: :
This study showed that a clinically relevant number of ketorolac 0.4% and control patients experienced a 10% or greater increase in retinal thickness following cataract surgery as measured by OCT. ACULAR LS treatment was not different from the NSAID–free group in preventing cystoid macular edema when dosed for 1 day prior to and for one month following cataract surgery.
Keywords: clinical (human) or epidemiologic studies: outcomes/complications