Abstract | PURPOSE: To evaluate the safety and efficacy of dexamethasone as a sustained-release drug depot when placed in the canaliculus for the treatment of ocular inflammation and pain in cataract surgery patients. SETTING: Four private practice sites in the United States. DESIGN: Multicenter randomized double-masked clinical trial. METHODS: Patients were randomized (1:1) to receive either the sustained-release dexamethasone or a placebo vehicle punctum plug inserted into the inferior distal canaliculus of the operated eye intraoperatively during cataract surgery. The primary endpoints were the proportions of patients with absence of cells or pain in the anterior chamber at 8 days. Secondary endpoints included cells, flare, pain, and the presence of the device at various timepoints through 30 days. RESULTS: Approximately one fifth (20.7%) of patients in the sustained-release dexamethasone group had an absence of anterior chamber cells at 8 days compared with 10.0% in the placebo group (P = .1495). A higher proportion of patients in the sustained-release dexamethasone group (79.3%) than in the placebo group (30.0%) had an absence of ocular pain at 8 days (P < .0001) and at all other timepoints (P < .0002). There were significantly higher proportions of patients in the sustained-release dexamethasone group than in the placebo group with an absence of anterior chamber cells, anterior chamber flare, and pain at several timepoints through 30 days (P ≤ .0251). CONCLUSION: FINANCIAL DISCLOSURE: Dr. Masket is a consultant to and shareholder in Ocular Therapeutix, Inc. No other author has a financial or proprietary interest in any material or method mentioned.
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Authors | Thomas Walters, Michael Endl, Thomas R Elmer, Jeffrey Levenson, Parag Majmudar, Samuel Masket |
Journal | Journal of cataract and refractive surgery
(J Cataract Refract Surg)
Vol. 41
Issue 10
Pg. 2049-59
(Oct 2015)
ISSN: 1873-4502 [Electronic] United States |
PMID | 26703279
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Delayed-Action Preparations
- Glucocorticoids
- Dexamethasone
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Topics |
- Aged
- Delayed-Action Preparations
- Dexamethasone
(administration & dosage, adverse effects)
- Double-Blind Method
- Endophthalmitis
(drug therapy, etiology)
- Eye Pain
(drug therapy, etiology)
- Female
- Glucocorticoids
(administration & dosage, adverse effects)
- Humans
- Intraocular Pressure
(physiology)
- Lens Implantation, Intraocular
- Male
- Middle Aged
- Pain Measurement
- Phacoemulsification
- Postoperative Complications
(drug therapy)
- Prospective Studies
- Surveys and Questionnaires
- Visual Acuity
(physiology)
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