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J. R. Wittpenn, S. Silverstein, J. Hunkeler, K. Kenyon, ACME Study Group; Subclinical CME Reduces Contrast Sensitivity and Final Visual Acuity in Low Risk Cataract Patients. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5464.
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© ARVO (1962-2015); The Authors (2016-present)
Determine the incidence and characteristics of subclinical cystoid macular edema (CME) in cataract patients without apparent risk factors when treated with steroids alone versus steroids plus ketorolac.
Randomized, investigator-masked, multi-center clinical trial. Low-risk patients (n=546) undergoing cataract surgery were randomized into 1 of 2 groups in a 1:1 ratio: Group 1 received ketorolac 0.4% QID for 3 days prior to surgery and 4 doses during dilation immediately before the procedure. These patients used ketorolac QID until they exited the study and also instilled prednisolone QID from 5 ml bottle until empty. Group 2 received a tear solution for 3 days prior to surgery and only 4 doses of ketorolac 0.4% during dilation immediately before procedure. These patients continued to use the tear solution QID until the bottle was empty and instilled prednisolone QID from two 5 ml bottles until exiting the study. Follow-up study visits were on day 1 and between days 8-12 (Week 1), and days 26-34 (Week 4) postoperatively. Retinal thickening was measured by OCT at pre-op and follow up visits week 1 and week 4.
Use of ketorolac 0.4% significantly reduced the incidence of retinal thickening and CME. Group 1 patients were more likely than Group 2 patients to have retinal thickening <10 um (73.6% and 50.8%, respectively, P<.001). Group 2 patients were more likely than Group 1 patients to have retinal thickening of ≥ 10 um (49.2% and 26.4%, P<.001), ≥15 um (31.4% and 17.4%), or ≥25 um (11.5% and 8.4%, P=.056). Group 2 patients were significantly more likely than Group 1 patients to have CME as diagnosed by a masked retinal specialist (2.4% vs. 0%, respectively, P=.018). Patients with < 10 um of thickening had significantly better contrast sensitivity scores at 6.0, 12.0, and 18.0 cpd than patients with ≥10 um of thickening (P≤.032). There was also a trend toward worsening visual acuity with increased retinal thickening (P=.085).
These data demonstrate that even in low-risk cataract patients, retinal thickening of more than 10 microns (sub-clinical CME) affects visual quality. Ketorolac 0.4% significantly reduced the incidence of sub-clinical CME and the incidence of CME. These findings demonstrate that ketorolac 0.4% maximizes the potential of an excellent visual result in even low risk cataract patients.
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