Laser reduces IOP, minimizes risk of perforating trabecular membrane

The nonpenetrating carbon dioxide procedure yielded complete success in more than 86% of eyes.

A noninvasive, laser-based surgical device has shown promising results in reducing IOP, early clinical trial results showed. The procedure also eliminated the need for glaucoma medication in most patients, according to 6-month postoperative follow-up data.

The carbon dioxide laser reduces IOP while substantially limiting the risks and side effects of trabeculectomy and nonpenetrating deep sclerectomy, according to the laser’s manufacturer, IOPtima Ltd.

“The CO2 laser is not a newcomer in the medical world,” Joshua Degani, PhD, CEO of IOPtima Ltd., said in an interview with Ocular Surgery News. “It’s old. It’s one of the first and very commonly used in applications other than ophthalmology.”

The unique laser platform includes a beam manipulating system that comprises a scanner, micromanipulator and other components.

Joshua Degani

“What is new is the application that we have developed and the system — what we call the beam manipulating system — that takes the CO2 laser, which is sort of an engine, and drives it in the right way and with the right parameters to perform the procedure that we’re interested in. As our procedure involves only interaction of the sclera, the properties of the CO2 laser are ideal for the functional ablation result we are trying to achieve,” Dr. Degani said.

The multinational clinical trial is intended to gain regulatory approval in Europe. IOPtima and the U.S. Food and Drug Administration have begun discussing the U.S. approval process.

“We started the dialogue with them, and no doubt the strong clinical data thus far will provide us a good head start, but as of yet, we can only say that we have started the dialogue,” he said. “Everything else would be more speculative at this point.”

Investigators plan to collect study data for up to 1 year after surgery, according to an IOPtima news release.

Safety, efficacy and ease of use

The 6-month results showed that among 30 patients who underwent the procedure and completed 6 months follow-up, average IOP was reduced from 26 mm Hg to 14 mm Hg. The study was successful, with IOP being reduced to less than 18 mm Hg and the need for glaucoma medication completely eliminated in 86.7% of eyes, according to the news release.

The qualified success rate, in which internal eye pressure was maintained at less than 18 mm Hg, including cases in which at least some postoperative medications were used, was 93.5%. The average number of medications fell from a baseline of 2.28 medications to 0.27 medications 6 months after surgery, the release said.

Primary indications for the laser procedure in the trials were IOP more than 21 mm Hg at maximum, medications and need for glaucoma surgery, Dr. Degani said.

Nonpenetrating deep sclerectomy yields a lower complication rate than trabeculectomy. However, performing nonpenetrating deep sclerectomy without perforating the trabecular membrane is difficult; relatively few surgeons are able to perform nonpenetrating deep sclerectomy, according to the release.

The laser procedure poses a lower risk of perforating the membrane because laser ablation stops when optimal thickness of the membrane is reached and the beam contacts percolated intraocular fluid, Dr. Degani said.

“The removal of the layers of the sclera is functional,” he said. “You don’t need to know in advance the thickness that you want to remove. You remove layer by layer. As long as you don’t get percolation, you keep removing layers of sclera.”

As an example of the laser’s ease of use, Dr. Degani recalled one surgeon who, on the first day using the device, successfully operated on nine patients in 4.5 hours.

“The learning curve was short, and it was easy to adopt,” he said. “The nice thing is that the system is very friendly because removal of the scleral thickness is not done manually but is done with the laser.” – by Matt Hasson

• Joshua Degani, PhD, can be reached at IOPtima Ltd., Paz Tower, 5-7 Shoham St., Ramat Gan, Israel 52521; +972-3-753-4100; fax: +972-54-785-5252; e-mail: josh@bio-light.co.il.