ReSure Sealant Pivotal Clinical Trial
A prospective, randomized, parallel-arm, active controlled, multicenter, subject-masked study was conducted to evaluate the safety and effectiveness of the ReSure Sealant compared to a 10–0 nylon suture (3:1:1 with buried knot) for preventing incision leakage within the first 7 days of surgery, in uneventful clear corneal cataract surgery where a wound leak had previously been demonstrated.
487 patients (488 eyes) were randomized in a 5:3 ratio to receive the ReSure Sealant or suture, respectively. Following cataract surgery with IOL implantation, 50% of clear corneal incisions leaked spontaneously, and those that did not were challenged using an Ocular Force Gauge (OFG).1 The foot of the applicator was placed near the CCI on the scleral side of the wound and up to 1.0 oz. force was applied. In previous trials, 1.0 oz. applied force using the OFG raised intraocular pressure a mean of 25.95 mmHg from baseline, which is consistent with digital forces on the eye as reported in the literature.2
Terry Kim, MD, Professor of Ophthalmology, Duke University, demonstrates the procedure and shows the effectiveness of the ReSure Sealant in preventing wound leaks after clear corneal cataract surgery.
Patients were randomized into the study if a leak was observed with < 1.0 oz. force. If no leak was observed, patients were considered screen failures. After application of the ReSure Sealant or suture, CCIs were challenged again using the OFG with up to 1.0 oz. force. If a leak was detected, the patient was a primary endpoint failure. Subjects were evaluated at 1 hour, and at 1, 3, 7, 14, 21 and 28 days after surgery. Subjects were exited from the study at day 28. The primary endpoint was the proportion of eyes with wound leakage within the first 7 days of surgery.
Prior to device placement, 98% of clear corneal incisions leaked either spontaneously or during the initial wound challenge assessment following cataract surgery. Of the 488 eyes which demonstrated leakage, 50% of wounds leaked spontaneously and nearly 76% of CCIs leaked spontaneously or with minimal touch of ≤ 0.25 ounces force using the OFG. See Cumulative leak rates prior to device placement.
In the trial, the ReSure Sealant demonstrated superiority over sutures by successfully preventing wound leaks in 95.9% of cases, compared to sutures in only 65.9% (p<0.0001) of cases. See Per protocol leak rates following device placement.
In addition, the ReSure Sealant demonstrated significantly fewer device-related adverse events than the control group (p<0.0001), at 1.6% versus 30.6%, respectively. No safety concerns were reported, and patients were comfortable overall. 94.1% of the ReSure Sealant cases were rated ‘easy’ or ‘very easy’ to use. For more data on the ReSure Sealant, please visit Resources.
|Subjects with no AEs||235 (77.3%)||100 (54.6%)||<0.0001|
|Subjects with at least one AE||69 (22.7%)||83 (45.4%)||<0.0001|
|Subjects with device-related AE(s)||5 (1.6%)||56 (30.6%)||<0.0001|
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