BOSTON —The ocular ReSure Sealant (Ocular Therapeutix) provides a convenient, safe, and effective alternative to sutures after cataract surgery, according to results from a pivotal phase 3 randomized trial.
Corneal wound leaks are common after cataract surgery; the rate is as high as 85%, said Terry Kim, MD, professor of ophthalmology at the Duke University Eye Center in Durham, North Carolina.
"Even perfectly constructed wounds can be compromised with internal or external pressure or manipulation," he said.
Dr. Kim, who was among several speakers describing results with the ReSure Sealant, presented the findings here at the American Society of Cataract and Refractive Surgery 2014 Symposium.
The sealant, a synthetic polyethylene glycol hydrogel, was approved by US Food and Drug Administration in January. It is the first gel sealant approved in the United States to prevent wound leaks after cataract surgery.
The trial involved 487 patients at 24 sites who were undergoing uncomplicated cataract or intraocular lens placement surgery with incisions of 3.5 mm or less.
Patients were randomized to receive the sealant (n = 304) or 10-0 nylon sutures using a 3-1-1 technique with a buried knot (n = 183).
Up to 50% of the eyes exhibited spontaneous leakage prior to randomization. To challenge the effectiveness of the remaining wounds, 1 ounce of force was applied to the scleral side of the limbus next to the incision; this simulated intraocular pressure fluctuations that can be caused by patient manipulation.
The wound leak rate was significantly higher with sutures than with the sealant (31.7% vs 3.6%; P < .0001). Device-related adverse events were also significantly higher in the suture group (30.6% vs 1.6%; P < .0001).
Premature device removal related to adverse events was more common in the suture group than in the sealant group (12.6% vs 0.3%).
"The suture group had a leakage rate that was as much as 8 times greater than the sealant rate," Dr. Kim reported. "Meanwhile, there were very low adverse events and no safety concerns with the sealant. Patients were very comfortable with the product on the eye."
Furthermore, the sealant dries very quickly. "It applies as a liquid but it gels very quickly," he said. "It has taken less than 30 seconds in all of the cases I've used it in."
The study highlights another finding related to cataract surgery wounds, beyond the effectiveness of the ocular sealant, Dr. Kim explained. It was surprising that up to "50% of these wounds leak spontaneously."
"This is probably the first prospective study of this type to evaluate clinical incisions in a controlled manner," he said.
A Single-Center Study
The sealant and sutures for the prevention of leakage after cataract surgery were also compared in a single-center study conducted by Charles Reilly, MD, from F & R Eye Associates in San Antonio.
Prior to treatment, 26 of 40 eyes (65%) leaked spontaneously, and 13 of the remaining 14 eyes (93%) leaked with mild provocation.
After treatment, none of the 24 subjects in the sealant group had leaks when provoked, compared with 5 of the 16 patients (31%) in the suture group.
One explanation for the improved results with the sealant is its greater coverage of the wound, Dr. Reilly said.
"The sealant goes across the entire length of the wound, as opposed to a suture, which only goes in the center of the wound. I think that is the biggest advantage of using the sealant — you actually get full wound coverage," he explained.
Session moderator Steven Dewey, MD, an ophthalmologist practicing in Colorado Springs, Colorado, said he agreed that the research is interesting on several levels.
"The interest in this product is fairly high, and I think many doctors will find it surprising that their incisions appear to have this type of susceptibility," he told Medscape Medical News.
Dr. Dewey questioned the role of the focal pressure placed on the wounds in the trial, but added that the results nevertheless speak for themselves.
"I don't know if the challenge really simulated the kind of true eye rubbing or blinking that takes place, but it did show the sealant to be more effective in creating a water-tight incision stronger than sutures alone under the specific testing methods," he said.
It could be that chronic eye rubbers and patients prone to infection will benefit more from the sealant than others.
Cost an Issue
At approximately $75 per case, according to Dr. Kim, the ReSure Sealant exceeds the relatively small cost of sutures.
"With increasing pressure on surgeons to be cost efficient in the operating room, one will have to ask if it makes sense to use this on every case," said Dr. Dewey.
In some cases, however, the convenience of the sealant will be appreciated, he added.
"The last thing you want is to have a challenging case and find yourself struggling to sew a suture to make sure it is closed," he explained. "This seems like a very convenient alternative."
Dr. Kim is a consultant for Ocular Therapeutix. Dr. Reilly and Dr. Dewey have disclosed no relevant financial relationships.
American Society of Cataract and Refractive Surgery (ASCRS) 2014 Symposium. Presented April 25, 2014.
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Cite this: Ocular Sealant Superior to Sutures After Cataract Surgery - Medscape - Apr 30, 2014.