The multicenter clinical trial will randomly assign patients to either application of the hydrogel polymer at the end of the procedure or sutured incision closure. Patients will be followed postoperatively for assessment of wound leaks, measurement of IOP, and cylindrical change.
Steven J. Dell, MD, is an investigator in the pivotal trial and also participated in a previous randomized, controlled, U.S. multicenter study that evaluated the safety and efficacy of the hydrogel for providing ocular protection and relief of pain or discomfort in the acute postoperative period after cataract surgery [Dell SJ, Hovanesian JA, Raizman MB, et al. J Cataract Refract Surg. 2011;37:113-121].
"Although clear corneal incisions may appear sealed when they are tested at the end of the procedure and when the patient returns for the postop day 1 visit, there can be transient hypotony between these time points causing a less-than-optimally constructed incision to gape open," said Dr. Dell, medical director of Dell Laser Consultants, Austin, TX. "There has been increasing evidence in the literature that these wound gapes in the early postoperative period may allow egress of intraocular fluids, which can lead to minor or severe complications following surgery.
"Complications resulting from cataract surgery are rare, however, they can be devastating when they occur," he added. "Therefore, any intervention offering the potential to maintain a sealed incision postoperatively warrants investigation."
The hydrogel bandage is reconstituted just prior to application using the supplied polyethylene glycol powder and diluent-activating solution. Mixing the two agents together results in a liquid that is transferred onto the ocular surface using a supplied applicator. The liquid forms a soft flexible gel in situ on the ocular surface.
The formulation also includes a blue colorant that enables product visualization during application, but the color disappears quickly. Thereafter, persistence of the ocular hydrogel bandage can be demonstrated with fluorescein staining.
"My experience using the product in the previous randomized trial showed it was quick and easy to use and remained on the incision in the immediate postoperative period when wounds are most vulnerable," Dr. Dell said. "After which, it gently sloughs off in the patient's tears."
He noted that while there is good reason to investigate the efficacy and safety of the ocular hydrogel bandage for covering the clear corneal incision after cataract surgery, looking ahead to its possible approval, the introduction of the product will certainly generate discussion about cost and reimbursement.
"Cataract surgery is arguably one of the most successful operations in medicine today, and in today's economic environment, when any new product is added into the mix, it is valid to ask how it will be paid for and where it will fit in," Dr. Dell said.
The in situ gel-forming hydrogel is CE Mark approved as a nonmedicated temporary protective barrier for ocular surface protection and prevention of irritation-induced pain or discomfort when it is applied to corneal, scleral, and conjunctival tissues.