Results of a randomized, controlled U.S. pivotal trial of cataract surgery patients confirmed the efficacy and safety of a novel topical ocular bandage for protecting clear corneal incisions and minimizing postoperative pain.
The ocular bandage is a polyethylene glycol hydrogel with an oligopeptide that is applied topically to the incision site. The results of the pivotal trial supported a 510(k) submission, and FDA clearance is pending. The ocular bandage product is commercially available in Europe (under the tradename I-Zip Adherent Ocular Bandage, Ocular Therapeutix), and the same technology has been applied in other surgical disciplines with more than 500,000 uses.
The pivotal study enrolled 420 patients treated by 37 surgeons at 17 investigational sites, said Dr. Dell, a pivotal trial investigator and private practitioner in Austin, TX.
Primary efficacy endpoints included device success for protecting the ocular surface, assessed by the presence of the product over the de-epithelialized corneal incision at 24 hours, and pain during the first 4 hours after surgery, measured as the maximal pain score using a 0 to 10 rating scale. For both outcomes, the results were superior for the group receiving the investigational ocular bandage versus the controls.
"Concurrent with [a recent] shift in surgical technique [to clear cornea incisions and sutureless incisions] and despite the advent of better antibiotics for infection prophylaxis, the rate of postoperative endopthalmitis increased four-fold," he said. "Use of clear corneal incisions has been implicated as a contributor to the rising infection rates because the incision may gape open if the postoperative IOP is low."
Ease of use
The product is reconstituted just prior to use by mixing the supplied diluent and powder, and it is applied to the cornea using a foam tip applicator. Application is easy, and the hydrogel acts almost instantly to seal the incision.
"The ocular bandage covers the de-epithelialized surface of the clear corneal incision and provides a transparent protective barrier from the external environment," Dr. Dell said. "[Its initial blue hue] disappears quickly, but the presence of the bandage can be visualized by staining with fluorescein, and it has been shown to stay where it is placed until it dissolves over a period of about a week."
Other outcomes from the U.S. pivotal clinical trial also showed advantages for the investigational product. Compared with the control group, patients treated with the ocular bandage had a significantly lower rate of adverse events, significantly better best-corrected visual acuity at 4 hours, and significantly lower rates of stromal and epithelial edema.
Steven J. Dell, MDPhone: 512/771-0852
Dr. Dell is a consultant to Ocular Therapeutix.