A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients.
OBJECTIVE
To evaluate whether adding perioperative topical ketorolac tromethamine 0.4% improves cataract surgery outcomes relative to topical steroids alone in patients without known risk factors for cystoid macular edema (CME).


METHODS
Prospective, randomized, investigator-masked, multicenter clinical trial.


METHODS
Patients scheduled to undergo phacoemulsification and with no recognized CME risks (diabetic retinopathy, retinal vascular disease, or macular abnormality) were randomized to receive either prednisolone acetate 1% 4 times daily (QID) alone (steroid group; n = 278) or prednisolone 1% QID plus ketorolac 0.4% QID (ketorolac/steroid group; n = 268) for approximately four weeks postoperatively. In the ketorolac/steroid group, patients also received topical ketorolac 0.4% QID for three days preoperatively. In both groups, patients received four doses of ketorolac 0.4% one hour before surgery. Patients with capsular disruption or vitreous loss intraoperatively were exited from the study. Outcome measures included CME incidence, retinal thickness as measured by optical coherence tomography (OCT), best-corrected visual acuity, and contrast sensitivity.


RESULTS
No patients in the ketorolac/steroid group and five patients in the steroid group had clinically apparent CME (P = .032). Based on OCT, no ketorolac/steroid patient had definite or probable CME, compared with six steroid patients (2.4%; P = .018). In the ketorolac/steroid group, mean retinal thickening was less (3.9 microm vs 9.6 microm; P = .003), and fewer patients had retinal thickening of more than 10 microm as compared with the steroid group (26% vs 51%; P < .001).


CONCLUSIONS
This study suggests that adding perioperative ketorolac to postoperative prednisolone significantly reduces the incidences of CME and macular thickening in cataract surgery patients already at low risk for this condition.
Wittpenn
John R
JR
State University of New York at Stony Brook, Stony Brook, New York 11790, USA. jrwittpenn@aol.com
Silverstein
Steven
S
Heier
Jeffrey
J
Kenyon
Kenneth R
KR
Hunkeler
John D
JD
Earl
Melissa
M
D000287:Administration, Topical; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D015350:Contrast Sensitivity / Q000502:physiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D020911:Ketorolac Tromethamine / Q000008:administration & dosage* / Q000009:adverse effects; D019654:Lens Implantation, Intraocular; D008269:Macular Edema / Q000517:prevention & control*; D008297:Male; D015877:Miosis / Q000517:prevention & control*; D018918:Phacoemulsification; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011292:Premedication; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D000894:Anti-Inflammatory Agents, Non-Steroidal; D005938:Glucocorticoids; D020911:Ketorolac Tromethamine; C009935:prednisolone acetate; D011239:Prednisolone