SMALL CHALLENGE Surgeons can call on a widening variety of devices to deal with stubbornly narrow pupils.

What do cooks, woodworkers and cataract surgeons have in common? They all do better when they have lots of working space. Inadequate pupillary dilation occurs only in a small percentage of patients, but when it happens, it's important to have a solution at the ready. Fortunately, surgeons and surgery facilities have more mechanical and pharmaceutical options than ever. Here's a review.

Mechanical devices
Along with the traditional iris hooks, a growing number of ring-type devices are now available, promising greater efficiency and ease of use and low trauma to the iris.

All of the rings are effective, says T. Hunter Newsom, MD, founder of the Newsom Eye & Laser Center in Tampa, Fla. "The good news is that we have several different options that doctors can play with and see which fits well with their practice technique," he says. And, he adds, since companies with newer options are looking to get a foothold, they're usually happy to provide samples.

What factors are likely to affect buying decisions? Cost is a consideration, of course. Some rings are disposable, while some may be used up to 5 times. Some come attached to inserters, some require separate injectors that need to be sterilized between uses. Some are square, some provide a more circular space. For Dr. Newsom, the most important consideration is how easy it is to get the ring into the eye and back out again.

"Surgeons have different techniques, different likes and dislikes," he says. "The big thing is to try several different ones. The one that works best is the one that fits with your technique."

The updated Malyugin Ring is softer and can be inserted through smaller incisions.

Some options to consider:
Malyugin Ring 2.0 (MicroSurgical Technology). The popular ring has 8 points of fixation, with a goal of ensuring a round pupil (6.25 mm and 7 mm sizes are available), and reducing the risk of damage to the iris. Last year, the company released an updated version that's softer and more elastic, and can be inserted through smaller (1.8 to 2 mm) incisions. The smaller size is also intended to address inadequate pupil size during femtosecond laser cataract surgery. Like its predecessor, the ring looks like a baseball diamond with a loop at each corner. It's disposable and comes with newly designed disposable injectors that are easier to engage and disengage. The Osher Malyugin Ring Manipulator is reusable, however.

"I've become so comfortable putting it in and getting it out, and it is very stable," says Aaron Petersen, MD, of the Southwestern Eye Center in Mesa, Ariz.

"We've been using it since it was first marketed," says Jackie Dayton, RN, supervisor at Surgery Center of Ophthalmology Consultants in Fort Wayne, Ind. "Our doctors are very pleased with the ease of insertion and removal. And the manufacturer hasn't raised its price (about $125) in 5 years."

The Beaver-Visitec I-Ring Pupil Expander is designed to be easy to insert and remove, easy for surgeons to master, and gentle on iris tissue.

I-Ring Pupil Expander (Beaver-Visitec). This single-use device comes with its own inserter attached, so it can be placed and removed with one hand. It's made from pliable polyurethane, and unlike some other devices, it engages the iris completely and maintains 360-degree contact, creating a uniform, circular 6.3 mm diameter field. Outside the ring, 4 corners help hold the iris in place. Each has a positioning hole that's positioned away from the iris, thereby ensuring that the Sinskey hook used to engage and disengage the channels won't injure the iris.

It's designed to be easy for surgeons to master, and gentle on iris tissue while it firmly supports the entire pupillary margin.

"I like it because it's easy to deploy and remove, with minimal trauma to the iris," says Oswald Rondon, MD, of the Eye Clinic Surgicenter in Billings, Mont. "During surgery it's quite stable and doesn't interfere with my maneuvers or fluidics."

The Oasis Iris Expander has a specially designed pre-attached disposable inserter, helping to make it an economical alternative.

Iris Expander (Oasis Medical). This pupil expander is a more economical single-use polypropylene device that's available in 6.25 and 7 mm sizes. The disposable ring expands the pupil and maintains access and visibility throughout surgery. It comes with a pre-attached disposable inserter. It's indicated in cases where miosis and intraoperative floppy iris syndrome (IFIS) are present, says the company.

The Iris Expander's price ($85-$90) was a key factor in her center's decision to use it, says Sandra Roegelein, RN, director of the San Antonio (Texas) Eye Center. Her surgeons have been happy with the results. The pre-attached inserter is an important feature, she says. "We run multiple trays and there's always the potential of needing devices in back-to-back procedures. If we have only one inserter, we might not be able to turn it over right away."

Eagle Vision's Graether 2000 Pupil Expander can be placed through the phaco incision with one hand, thanks to a recently redesigned insertion instrument.

Graether 2000 Pupil Expander (Eagle Vision). This silicone ring with a groove in its outer surface works by engaging the sphincter's margin and expanding to a 6.3-mm opening. It can be accurately placed through the phaco incision, using one hand, thanks to a recently redesigned insertion instrument. In experienced hands, says the company, insertion is simple, quick and atraumatic, and removal takes only a few seconds.

The Diamatrix XpandNT Iris Expansion System can create up to 8 mm of dilation through an incision as small as 1.8 mm.

XpandNT Iris Expansion Speculum (Diamatrix). The low-profile pupil expansion ring is designed to gently expand the eye through 8 points of fixation that can be positioned (and removed) by any push-pull type manipulator. The device can create up to 8 mm of dilation through an incision as small as 1.8 mm, so the goal is to give surgeons extra room to maneuver while improving access to the anterior segment and posterior chamber. The company offers both single-use and reusable versions, the latter of which is validated for up to 5 uses. The single-use models list for $100 each, and a kit that includes 4 multi-use rings lists for $1,500. The multi-use rings alone are priced at $50 per use.

Proponents point to its utility in letting surgeons pre-operatively perform femtosecond capsulorhexis and lens fragmentation in patients with small pupils, something that's especially helpful for patients who want a premium IOL but who have poor dilation.

APX Ophthalmology's Assia Pupil Expander uses 2 small spring-loaded devices, making it easy to insert and remove.

Assia Pupil Expander (APX Ophthalmology). This disposable device, sometimes called just APX, uses 2 small spring-loaded devices that are inserted through 1.1-mm incisions. The surgeon positions the scissor-like configurations, which create a rectangular opening that's about 6 mm x 6 mm. No intraocular manipulation is needed. A distinguishing advantage, says the company, is that in the event of a posterior capsule rupture, the device can't fall into the vitreous cavity, because it isn't placed completely inside the eye. Insertion and removal take only a few seconds, says the company.

Omidria continuously promotes dilation as you irrigate the eye, and its formulation includes ketorolac, which dramatically reduces post-op pain.

Pharmaceutical pupillary maintenance
On the pharmaceutical side, Omidria (Omeros) is a combination of phenylephrine and ketorolac that can be added directly to the BSS solution. Unlike rings, this product doesn't depend on surgical skill, and providers say it does a great job of continuously maintaining dilation as you irrigate the eye. "It really works," says Glenn N. Pomerance, MD, owner and medical director of Renaissance Surgery Center in Chattanooga, Tenn., "especially in difficult cases, such as glaucoma, IFIS and diabetes." Dr. Pomerance also likes the fact that Omidria is manufactured in a strictly regulated proprietary drug manufacturing facility rather than a compounding lab.

The worry is the economics. At $465 for a 4 mm vial, "It's expensive," says Dr. Pomerance. For most Medicare Part B cases that's not a big concern at the moment, since the cost is reimbursed by Medicare as a pass-through (at least through the end of this year). However, patients on some Medicare Advantage plans may not qualify for the pass-through. When that happens, surgery centers and HOPDs can end up on the hook for the full cost. Well aware of such concerns, Omeros offers a patient-assistance program to help overcome financing difficulties. However the process is a lot of work, says a director of surgical services in New England. One other note: drug prices typically drop significantly once their pass-through status has expired.

"Shugarcaine" (compounded epinephrine and lidocaine), the most popular intra-operative alternative, is much less expensive, but needs to be delivered as a bolus at the beginning of the case, because it gradually wears off as surgery progresses. This product is only available from compounding labs; it has not gone through FDA's demanding pre-market approval process.

"Reliable and predictable," is how Ms. Dayton describes it. "But since ASCs are not allowed to mix their own anymore, we've had to resort to purchasing it from a compounding pharmacy, which has increased our cost." But, she says, the price increase turned out to be worth it for her surgeons' peace of mind. When the price went up, "they tried using it only for stubborn pupils. It took them only one day to realize how much they depend on it and how much they missed it. We now use it on every cataract case." OSM