Phase II results of an intraocular steroid delivery system for cataract surgery☆
Section snippets
Patients and methods
The DEX DDS is a white/off-white rod-shaped filament approximately 0.5 mm in diameter and 1.0 mm in length composed of dexamethasone in a biodegradable polymer matrix. It contains nominally 60 μg of dexamethasone (United States Pharmacopeia). The placebo DDS is identical to the DEX DDS in both appearance and composition of the matrix but contains no dexamethasone.
The protocol and informed consent forms were approved by the Institutional Review Board at each investigational site, and a written
Results
Ninety patients requiring cataract surgery were randomized in a 2-to-1 ratio into active or control treatment groups at 4 study centers. Thirty patients were assigned to receive 2 DEX DDSs, 30 were assigned to receive 1 DEX DDS, 15 were assigned to receive a placebo DDS, and 15 were assigned to receive no treatment. One patient assigned to receive one DEX DDS actually received no treatment, while another patient assigned to receive a placebo DDS actually received two DEX DDSs. Eighty-nine
Discussion
Although steroids are widely used in the treatment of postoperative inflammation after cataract surgery, there are few studies in the literature documenting the efficacy of this treatment. When this study was initiated, rimexolone (Vexol, Alcon) was the only steroid that had been proved efficacious over placebo by a randomized, prospective study and approved by the United States Food and Drug Administration for the treatment of postoperative inflammation.9, 10 For this reason, the DEX DDS was
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Is Demodex Blepharitis Connected With Cataract Surgery?
2023, American Journal of OphthalmologyDropless Cataract Surgery
2023, Advances in Ophthalmology and OptometrySustained-release dexamethasone for the treatment of ocular inflammation and pain after cataract surgery
2015, Journal of Cataract and Refractive SurgeryCitation Excerpt :Between postoperative 4 days and 45 days, 3.5-fold to 6.5-fold fewer sustained-release dexamethasone patients than placebo patients required rescue medications. These results corroborate those of Chang et al.,24 who reported that fewer patients receiving dexamethasone required rescue medications than their counterparts on placebo. Through 30 days, the proportion of patients requiring rescue medications was less than 21% in the sustained-release dexamethasone group, indicating that the masked investigators judged that the dexamethasone alone was providing adequate control of postoperative inflammation in most cases.
Nonsteroidal Anti-inflammatory Drugs in Ophthalmology
2010, Survey of OphthalmologyCitation Excerpt :Even the newer, less potent corticosteroids may elevate IOP.1,83,84,192 It remains to be seen whether the newer corticosteroid delivery systems will overcome some of these toxicities.52,313 Corticosteroids have been compared to topical NSAIDs in an effort to establish their relative toxicities.
A biodegradable drug delivery system for the treatment of postoperative inflammation
2008, International Journal of PharmaceuticsOphthalmic Drug Delivery
2008, Clinical Ocular Pharmacology
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Supported by Oculex Pharmaceuticals, Inc., Sunnyvale, California.
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Dr. Hunkeler is an investor in Oculex Pharmaceuticals, Inc., and has received contract payments for research. None of the other authors has a proprietary interest in Oculex Pharmaceuticals or in the product discussed in this article.