Abstract
Abstract: :
Purpose: Combination topical therapy with a corticosteroid and a non–steroidal anti–inflammatory agent has been shown to be more effective than either agent dosed individually for treatment of cystoid macular edema (CME) following cataract surgery. This study compares combination therapy with diclofenac sodium 0.1% and prednisolone acetate 1% (D), with ketorolac tromethamine 0.5% and prednisolone acetate 1% (K), for treatment of CME following uncomplicated cataract surgery. Methods: Sixty–eight consecutive patients with CME following uncomplicated phacoemulsification cataract removal and posterior chamber intraocular lens implantation surgery were randomized to combination therapy with either diclofenac sodium 0.1% and prednisolone acetate 1% (D) or ketorolac tromethamine 0.5% and prednisolone acetate 1% (K). One drop of each medication was given four times daily to the affected eye. The bottles were unmasked. Thirty–six patients were randomized to D and thirty–two patients were randomized to K. Exclusion criteria included complicated surgery with posterior capsule rupture and vitreous loss, intraocular surgery before or after cataract surgery, CME over one year duration, uveitis history, and pre–existing retinal pathology such as macular hole, epiretinal membrane, macular scar, macular edema or vein occlusion. Results: The mean age was 74.9 years for group D and 73.7 years for group K. The mean initial visual acuity (VA) was 20/163 for group D and 20/137 for group K. The mean final VA was 20/51 for group D and 20/72 for group K. The mean time to initial VA improvement was 2.1 months for group D and 2.3 months for group K. The mean time to final VA improvement was 3.2 months for group D and 4.3 months for group K. The mean final VA improvement was 3.0 lines for group D and 2.6 lines for group K. At least partial response to treatment was noted in all 36 patients in group D, and in 28 of 32 patients in group K (88%). Complete resolution of CME was noted in 10 of 36 patients in group D (28%), and in 8 of 32 patients in group K (25%). Final VA improved two or more lines in 30 of 36 patients in group D (83%), and in 19 of 32 patients in group K (59%). Final VA improved three or more lines in 21 of 36 patients in group D (58%), and in 17 of 32 patients in group K (53%). All patients completed at least 3 months of treatment. None of the patients showed signs of corneal toxicity or significant intraocular pressure rise during the treatment period. Conclusions: Combination therapy with either D or K is effective in reducing the severity of pseudophakic CME and in improving final VA.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • macula/fovea • treatment outcomes of cataract surgery