Purpose:
To compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.
Methods:
This was a masked single-center, randomized clinical study that comprised 46 patients undergoing phacoemulsification cataract surgery. Patients scheduled to undergo phacoemulsification and with no recognized cystoid macular edema (CME) risks (diabetic retinopathy,retinal vascular disease or macular abnormality) were randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group;n=25) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group;n=21) for three days preoperatively and four weeks postoperatively. In both groups topical gatifloxacin was administered to the treated eye QID, starting three days before surgery and continuing for seven days. The primary outcome measured on the 30th day after surgery was best corrected visual acuity (BCVA). Other outcomes included were intraocular pressure (IOP), CME incidence, retinal thickness as measured by spectral-domain optical coherence tomography (OCT).
Results:
The average age of patients were 67.88 years (SD=8.85) in placebo group versus 67.29 years (SD=12.10) in ketorolac group (P=0.849). The mean BCVA was 0.086 logmar (0.82 snellen decimal scale) in placebo group versus 0.167 logmar (0.68 snellen decimal scale) in ketorolac group (P=0.045). The mean IOP was 13.08 mmHg (SD=2.66) in placebo group versus 13.05 mmHg (SD=2.85) in ketorolac group (P=0.968). No patient had clinically significant CME. One (4%) patient in the placebo group and two (9.52%) patients in the ketorolac group had angiographic CME (P=0.584). Mean retinal thickening was 228.56µm (SD=24.95) in the placebo group versus 224.86µm (SD=22.33) in the ketorolac group (P=0.602).
Conclusions:
This study suggests that there is no need to add ketorolac tromethamine 0.4% ophthalmic solution to routine cataract surgery.
Clinical Trial:
http://www.clinicaltrials.gov NCT00865540
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • macula/fovea • cataract