Abstract | PURPOSE: 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.
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Authors | D F Chang, V Wong |
Journal | Transactions of the American Ophthalmological Society
(Trans Am Ophthalmol Soc)
Vol. 97
Pg. 261-74; discussion 274-9
( 1999)
ISSN: 0065-9533 [Print] United States |
PMID | 10703128
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Drug Implants
- Glucocorticoids
- Ophthalmic Solutions
- Dexamethasone
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Topics |
- Aged
- Anterior Chamber
(drug effects)
- Dexamethasone
(administration & dosage, therapeutic use)
- Double-Blind Method
- Drug Delivery Systems
- Drug Implants
- Glucocorticoids
(administration & dosage, therapeutic use)
- Humans
- Iridocyclitis
(etiology, prevention & control)
- Lens Implantation, Intraocular
- Ophthalmic Solutions
(administration & dosage)
- Phacoemulsification
(adverse effects)
- Prospective Studies
- Safety
- Treatment Outcome
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