By Emily Miller
The U.S. Food and Drug Administration approved the first gel for use in stopping fluid from leaking through the incision in a patient’s cornea after a cataract surgery.
Prior to this approval, stitches were the only option for closing a leaking incision 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,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Disease and Radiological Health.
The ReSure Sealant kit comes as two liquid solutions that the surgeon mixes together just prior to sealing the incision. Using a foam-tipped applicator – provided in the kit, the surgeon applies the mixture directly to the incision.
Within 20 seconds of applying the liquid to eye tissue, 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 ReSure Sealant was evaluated in a randomized, control clinical study of 471 adult subjects who underwent cataract surgery and experienced some post-surgery leakage; 295 received the ReSure sealant to stop leakage and 176 received a suture.
The gel sealant proved to be more effective than a single suture in preventing incision leakage in the first seven days following surgery, according to the FDA.
There was no comparable difference between the rates of eye pain and sensation of having in the eye between the two groups. There were also no significant differences in the occurrence of corneal swelling, inflammation, or wound healing between both groups, according to the FDA.
No serious device-related adverse events were reported.
The study excluded individuals with a history of eye trauma or surgeries; individuals with certain diseases such as insulin-dependent diabetes, glaucoma, or malignancies; and individuals who used certain medications in the weeks prior to cataract surgery.
The gel is also approved for use on cataract surgeries on patients with clear corneas, but has yet to be studied on patients with clouded corneas.
Patients who undergo cataract surgery suffer from loss of vision due to gradual clouding of the eye’s lens. It is often the result of aging, but can have other causes – including diabetes, excessive smoking and alcohol use and prolonged exposure to sunlight.
According to the National Institutes of Health, by age 80, more than half of all Americans have either a cataract or have had cataract surgery.
Cataract surgery is a procedure to restore vision by removing the eye’s natural lens and replacing it with an article lens. It is one of the common operations performed in the United States and also one of the safest and most effective types of surgery.
The NIH stated that people who have undergone cataract surgery saw sufficient improvements in their vision. So, if cataract surgery is in your future, consult with your physician to see if ReSure is right for you and whether it is covered under your current health insurance policy.
