Two clinical trials of an intraocular steroid delivery system for cataract surgery.

摘要

PURPOSE: To determine the safety and efficacy of an intraocular dexamethasone drug delivery system (Surodex) in the treatment of inflammation following cataract surgery. METHODS: Surodex is a biodegradable polymer that releases dexamethasone for 7 to 10 days after placement in the anterior segment. Study 1 was a prospective, randomized, double-masked Phase II clinical trial of 90 cataract surgical patients that compared treatment with Surodex to treatment with a placebo drug delivery system and to no anti-inflammatory drug treatment at all. Study 2 was a separate prospective, randomized, double-masked study of 60 cataract surgical patients that compared treatment with Surodex to topical dexamethasone (eye drop) therapy. RESULTS: In the first study, Surodex was superior to placebo in suppressing postsurgical inflammation throughout the 60-day postoperative period, as judged by masked-evaluator, slit-lamp grading of cell and flare. The differences were statistically significant from postoperative day 3 through postoperative week 3. The majority of Surodex patients did not require topical steroid by 2 weeks after surgery (93%) or by 2 months after surgery (88%). In the second study, Kowa laser flare meter readings were lower in Surodex patients throughout the 90-day postoperative period. The results were statistically significant at 4, 8, and 15 days following surgery. There were no significant adverse complications of Surodex in either study. CONCLUSION: Surodex was safe and effective in suppressing postcataract surgery inflammation and appears to be a promising alternative to topical steroids.