Hydrogel ocular bandage proves safe and effective after cataract surgery

The material enhanced wound coverage, healing and comfort in patients who had cataract surgery.

Y. Ralph Chu

A novel gel-like ocular bandage applied after cataract surgery to aid wound closure has proven safe and effective in early clinical testing, according to one U.S. investigator.

Y. Ralph Chu, MD, presented results of a pilot study on a hydrogel ocular bandage (Ocular Therapeutix) at a recent meeting.

“I think it’s going to play a significant role,” Dr. Chu said. “At least I can speak for my practice — not just in the presbyopic-correcting patients, but I think in most cataract surgeries — because I think that peace of mind, that comfort that I’ve seen from using it, will allow us to have some broad applications for this in our practice. I look forward to seeing how this progresses through the FDA clinical trial.”

At present, a multicenter pivotal trial with 420 patients is complete and the file has been submitted to the U.S. Food and Drug Administration, according to Ocular Therapeutix.

The ocular bandage is a synthetic PEG-based hydrogel with approximately 90% water content that is highly adherent, 100% synthetic and thus biocompatible. It is applied as a liquid and becomes a gel-like bandage that provides a temporary barrier over corneal incisions. The material softens and washes away with tears, Dr. Chu said.

Results of the randomized U.S. pilot study showed the ocular bandage was adherent and well-tolerated among patients and was associated with no adverse events, Dr. Chu said.

Randomized pilot study

The pilot study was conducted at two sites by Dr. Chu and Stephen S. Lane, MD. The study included 20 patients who underwent cataract surgery and were randomized to receive either the ocular bandage or the Soft Shield 24-Hour Collagen Corneal Shield (Oasis Medical).

Fourteen patients received the ocular bandage, and six patients received the corneal shield. The ocular bandage group had a mean age of 67.4 years, and the corneal shield group had a mean age of 71.3 years.

All 14 patients in the ocular bandage group underwent cataract surgery through single-plane corneal incisions. Nine received temporal incisions, one received supratemporal incisions and four had nasal incisions. Mean incision width was 2.6 mm.

All six patients in the corneal shield group also underwent cataract surgery through single-plane corneal incisions. Five received temporal incisions and one received a nasal incision. Mean incision width was 2.7 mm.

The primary endpoints were the extent to which the devices remained localized over the cataract incision at 24 hours and the amount of pain patients experienced within the first 4 hours after surgery, Dr. Chu said.

Drs. Chu and Lane also assessed device safety at 30 days postop.

Patients were randomized at the conclusion of surgery. The devices were applied only to wounds that proved Seidel negative and showed no signs of leakage. No patients underwent patching.

“What’s nice is they have a dye in it,” Dr. Chu said. “It’s blue, so you can see it being applied. You can see where it goes, and that blue color basically dissipates within just 30 to 60 minutes. It becomes clear once you look at it postoperatively. Then the [ocular bandage] stays in place, and that was what we were looking at in the study.”

Ashesion, comfort and healing

Study results showed that at 24 hours, more than 50% of the incision was covered in 12 patients in the ocular bandage group (85.7%) and no patients in the corneal shield group, Dr. Chu said.

“The downside of a collagen shield is that it can fall out and disappear, even before the patient comes back for their first postoperative visit,” he said.

Data showed that the mean maximum ocular pain or discomfort score within the first 4 hours after surgery was 1.42 in the ocular bandage group and 1.67 in the corneal shield group.

Trace amounts of the ocular bandage material were present beyond 7 days in one patient.

“That’s because it got placed inside,” Dr. Chu said. “It got a little trapped inside the wound itself.”

Results showed normal incisional healing with no epithelial defects or wound leakage at 7 and 30 days. In addition, there were no clinically significant increases in IOP, inflammation or device-related adverse events, Dr. Chu said.

The ocular bandage and corneal shield were similarly easy to use, Dr. Chu said.

“You can see that it’s incredibly easy to use, even in these very first, initial experiences with two surgeons, and a very short learning curve for this device.” he said. – by Matt Hasson

• Y. Ralph Chu, MD, can be reached at Chu Vision Institute, 9117 Lyndale Ave. South, Bloomington, MN 55420; 952-835-0965; fax: 952-835-1092; e-mail: yrchu@chuvision.com.