BOSTON — A hydrogel sealant prevented wound leaks after cataract surgery, according to a study presented here.
At the American Society of Cataract and Refractive Surgery annual meeting, Terry Kim, MD, discussed results of a multicenter randomized pivotal trial to evaluate ReSure Sealant (Ocular Therapeutix). The U.S. Food and Drug Administration approved the sealant in January.
“ReSure Sealant demonstrated not only non-inferiority but superiority in prevention of fluid egress from these wounds that had demonstrated wound leak and had very few adverse events,” Kim said. “The ocular sealant was found to be very safe and effective for its intended use. I think it’s great to have the product FDA approved and available to us.”
The trial included 488 eyes of 487 patients enrolled at 24 sites in the United States. An ocular force gauge was used to test wounds for leakage before and after surgery. Patients were randomized 5:3 to receive ReSure Sealant or sutures.
Adverse event rates were 30.6% in the suture group and 1.6% in the ReSure Sealant group, which was a statistically significant difference (P < .0001); 12.6% of sutured patients required premature device removal because of an adverse event.
Adverse events for sutured incisions included subconjunctival hemorrhage, induced corneal astigmatism, infection, corneal edema, eye pain, irritation or discomfort, foreign body sensation and elevated IOP; 94.4% of sealant cases were rated easy or very easy to use.
The suture group had an eight times higher wound leak rate compared with the sealant group, Kim said.
“This is surprising and maybe points to the issue of a suture only covering one aspect of the wound while the sealant covers the entire wound,” he said.
Disclosure: Kim has a financial interest in Ocular Therapeutix, the sponsor of the study.