The US Food and Drug Administration (FDA) has approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient's cornea after cataract surgery.
The FDA has approved gels like ReSure for sealing small incisions in other parts of the body, such as the lungs, but this is a first-of-its-kind for the eye, explains Christy Foreman, director of the FDA's Office of Device Evaluation.
Usually, the incision made during cataract surgery is self-sealing. However, if fluid leaks from the incision, the surgeon may need to close the wound. The ReSure sealant, produced by Ocular Therapeutix, is made up of two liquid solutions that the surgeon mixes together just prior to sealing the incision. Using an applicator, the surgeon applies the mixture directly to the incision. After 20 seconds, a gel forms that adheres to the eye and seals the incision. The gel gradually breaks down over the course of seven days and is cleared from the body by the eye's natural tears.
The study excluded people who had a history of eye trauma or surgeries, patients with insulin-dependent diabetes or glaucoma, and anyone who used certain medications in the weeks prior to cataract surgery.
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