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: Sustained-release dexamethasone provided elution of drug for up to 1 month after cataract surgery, providing clinically significant reductions in inflammation and pain. 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.
Subject(s)
Dexamethasone/administration & dosage , Endophthalmitis/drug therapy , Eye Pain/drug therapy , Glucocorticoids/administration & dosage , Lens Implantation, Intraocular , Phacoemulsification , Postoperative Complications/drug therapy , Aged , Delayed-Action Preparations , Dexamethasone/adverse effects , Double-Blind Method , Endophthalmitis/etiology , Eye Pain/etiology , Female , Glucocorticoids/adverse effects , Humans , Intraocular Pressure/physiology , Male , Middle Aged , Pain Measurement , Prospective Studies , Surveys and Questionnaires , Visual Acuity/physiologyABSTRACT
PURPOSE: To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery. SETTING: Twenty-four ophthalmic clinical practices in the United States. DESIGN: Prospective randomized parallel-arm controlled multicenter subject-masked study. METHODS: Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively. RESULTS: Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation (P<.0001). The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group (P<.05). CONCLUSIONS: In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress.
