Bac-Stat offers a bacteriostatic ring for LASIK

EUGENE, Ore. — Surgeons who like to use a ring during laser in situ keratomileusis (LASIK) to surround the flap cut during ablation now have a new tool to help prevent infections from entering the interface.

The new Bac-Stat bacteriostatic LASIK ring by American Optisurgical Inc. (Lake Forest, Calif.) acts as a barrier surrounding the ablation point to prevent microorganisms from migrating toward the exposed section of the cornea while the flap is turned back.

The Food and Drug Administration-approved preventive device adds a measure of safety during LASIK, according to the manufacturers. The blue sponge material combines the characteristics of PVA with the bacteriostatic properties of organic pigments gentian violet and methylene blue. Gentian violet dye is often used to mark the cornea. Only 0.5 ppm of the dyes are actually absorbed into the ring.

A bacterial inhibitor

“It’s a bacterial inhibitor. It inhibits the growth of bacteria, specifically the bacteria from the secretions of the meibomian glands around the eye. Similar to the Chayet ring, this ring serves as a dam as well, but goes one step further in inhibiting the growth of bacteria that comes in contact with the ring,” said Patrick Witham, CEO of Opti-Solution, an ophthalmology consulting firm that has worked with American Optisurgical on Bac-Stat.

The ring is hydrated and placed on the eye after the flap is made. Any secretions that would normally pass through a ring or simply move about an un-ringed cornea are prevented by the dyes in the Bac-Stat.

The Bac-Stat is 1 mm bigger than the Chayet ring, but its sponge material makes it adjustable by simply snipping off some of the PVA material if the patient’s eye is too small for the ring.

According to American Optisurgical, clinical studies have shown that the Bac-Stat inhibits the growth of microorganisms on the sponge for up to 7 days. Among the bacteria that Bac-Stat inhibits are Staphylococcus aureus, Escherichia coli, Yersinia enterocolitica, Serratia marcescens and Bacillus.

Two other advantages to the ring are that it helps keep glare off the eye during ablation and that its color helps make the flap more visible.

The Bac-Stat material also comes in two different forms: a Bac-Stat ring with a drain and a LASIK spear with the Bac-Stat material taking the place of the normal sponge material.

Several levels of usefulness

Mihir Parikh, MD, has been using the ring for a little over a month and referred to it as “fantastic.”

“It appeals to surgeons on several levels. First, it has a bacteriostatic effect, which may lower the risk of infection, and second it serves as a sponge for meibomian gland secretions and other debris that may get trapped under the flap. Also, its blue color increases the intraoperative visibility of the flap,” Dr. Parikh said.

He explained that while it is commonly held that the risk of infection during LASIK is extraordinarily small, the Bac-Stat ring offers a measure of comfort to surgeons and patients by acting as another level of protection for the eye.

And from an aesthetic point of view, Dr. Parikh said that somehow the blue coloring of the ring is more attractive than the other plain white rings on the market. He said patients waiting and watching from outside the operating area will often ask him what the ring is and what it is used for.

He said he also believes that the physical design of the ring is a bonus compared with other LASIK rings. Dr. Parikh said he feels more comfortable using this ring because it is slightly larger than the Chayet sponge and offers additional space around the limbus.

He said that while some surgeons may have concerns about the ring because of the gentian violet and methylene blue dyes, he has not observed any event of inflammatory or infectious keratitis with the arc of the ring. Dr. Parikh keeps the sponge very dry and uses an aspirating speculum. He said he believes that soaking the sponge would only take away from the ring’s effectiveness. “Keeping it dry on the eye will help it to absorb the eye’s natural tear secretions,” said Dr. Parikh, who said he only keeps the ring wet enough to adhere to the surface of the eye.

For Your Information:

• Patrick Witham can be reached at 134 E. 13th Ave., Ste. 4, Eugene, OR 97401; (541) 344-5499; fax: (541) 344-4531; e-mail: patrick@opti-solution.com; Web site: www.opti-solution.com.
• Mihir Parikh, MD, can be reached at 4150 Regents Park Row, Ste. 155, La Jolla, CA 92037; (858) 450-4213; fax: (858) 450-4219; e-mail: mparikh@arisvision.com. Dr. Parikh has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

• American Optisurgical, Inc., can be reached at 25501 Arctic Ocean, Lake Forest, CA 92630; (949) 580-1266; fax: (949) 580-1270; Web site: www.optisurgical.com.