Efficacy of topical flurbiprofen and indomethacin in preventing pseudophakic cystoid macular edema. Flurbiprofen-CME Study Group I.

We evaluated two topical cyclo-oxygenase inhibitors (COIs), 0.03% flurbiprofen and 1% indomethacin, for their ability to prevent pseudophakic cystoid macular edema (CME). The study was a randomized, double-masked, vehicle-controlled, parallel group, clinical trial for six months at eight sites in Canada and two in Germany. The study population consisted of 681 patients who had extracapsular cataract extraction and posterior chamber lens implantation. Flurbiprofen, indomethacin, or the vehicle was instilled into the eye four times daily for two days preoperatively and three months postoperatively. Results were measured by angiographic and clinical CME at visit 5 (day 21-60) and visit 7 (day 121-240) and by contrast sensitivity and Snellen visual acuity at all five postoperative visits. At visit 5, the incidence of angiographic CME was comparable in the two COI treatment groups (16.8% flurbiprofen, 12.4% indomethacin) and was significantly lower than in the vehicle group (32.2%). The incidence of clinical CME was also significantly lower in the COI-treated groups (10.7% flurbiprofen, 9.6% indomethacin) than in the vehicle group (21.9%). By visit 7, the incidence of angiographic CME had declined to between 4% and 8% and the incidence of clinical CME was less than 2% in all three groups. At visit 5, contrast sensitivity scores were significantly worse in vehicle-treated patients with angiographic CME than in those without CME, and Snellen visual acuity was one line worse in patients with CME. Flurbiprofen-treated patients achieved good Snellen visual acuity (better than 20/40) sooner than vehicle-treated patients.(ABSTRACT TRUNCATED AT 250 WORDS)