November 2018


Device focus
Artificial iris implants

by Michelle Stephenson EyeWorld Contributing Writer

This slit lamp image shows a CustomFlex Artificial Iris in the capsular bag, secured
temporally with a sutured Cionni CTR.

Preop image (above) of a patient who suffered a ruptured globe injury OS and the postop image (below) following sutured IOL and CustomFlex Artificial Iris placement
Source: Michael Snyder, MD


A look at the cosmetic and functional benefits of artificial iris implants

In May, the U.S. Food and Drug Administration (FDA) approved the first artificial iris implant (CustomFlex Artificial Iris, HumanOptics, Erlangen, Germany) in the country, and it is just now coming to the marketplace. Iris implants have both cosmetic and functional benefits for patients with congenital or acquired iris defects.
“Congenital defects usually fall into the complete aniridia or coloboma categories,” said Kevin M. Miller, MD, Kolokotrones Chair in Ophthalmology, Stein Eye Institute, University of California, Los Angeles. “Other congenital defects include oculocutaneous albinism, where the iris is structurally OK but is missing pigment, iridocorneal endothelial syndrome, and other dysgenesis syndromes.”
Dr. Miller said the overwhelming majority of his patients who would benefit from an artificial iris have suffered either surgical trauma, which is less common, or blunt or penetrating trauma. “Examples of penetrating trauma include scissors slicing into the eye or a bullet or glass going into the eye. Then there are defects from blunt trauma, like fist and racquetball injuries. Blunt traumas can be further divided into blunt with rupture of the eye or blunt without rupture. For example, a bad fist injury can damage the pupil and cause a mydriasis without rupturing the globe. On other occasions, the globe ruptures. As an example, one of my patients was at Dodger Stadium when a foul ball was hit in his direction. It hit him right in the face, fractured his orbit in several places, and blew out his eye,” Dr. Miller said.
Michael Snyder, MD, Cincinnati Eye Institute, Cincinnati, said that many of these patients have multiple holes or openings in the iris, which can cause multiple images. “They will look at one object and they’ll see three. They may see one primary object, a shadow image behind it, and a blurred image on top of it, all of the same thing. That’s really unpleasant,” he said.
Additionally, these patients experience a significant reduction in contrast. Dr. Snyder compares it to watching a movie in a dark room and having someone open the door to a well-lit hallway. “For the person who has an abnormal iris, light is getting through and around the defect. It’s the defocused light that impacts vision. These patients are living with this all day long. It’s not just the light sensitivity, it’s not just the halos, and it’s not just the glare. It’s also contrast sensitivity, shadow images, and multiple images. These iris devices can prevent excess light from entering the eye, whether focused or defocused, so that the eye is receiving an acceptable amount of light,” he said.
HumanOptics artificial iris
According to Dr. Miller, the HumanOptics artificial iris is just becoming commercially available. “For the next 2–4 years, we will be in limbo. We will have to go from one insurance company to the next, and do the same for the various government programs, to get them to pay for the device and the surgery to implant it. New CPT and HCPCS codes will have to be created. We will need to sort out whether patients will be allowed to pay for the device upfront and be reimbursed by their insurance. It’s going to be an interesting few years. I think the device may be less available during the next 4 years than it was during the clinical trial because of the red tape we’re likely to encounter,” he said.
According to Dr. Snyder, the device is customized to look like the patient’s other iris. “People who are congenital aniridics and are born with no irises will need to find a picture of eyes they like because they are custom-made one at a time. Each device is handmade to match the index photo that’s taken of the fellow eye. They are made out of a flexible silicone, and there’s a textured surface that is much like the native iris. Occasionally I will have a patient in whom I implanted a device years ago see a provider who isn’t familiar with the device. The provider will tell the patient that he or she is going to dilate the pupil. The patient will have to tell the provider that it’s plastic and doesn’t dilate. It’s quite realistic,” Dr. Snyder said.
He noted that the matches are good, but they are not all perfect. “Sometimes, it might be slightly lighter, slightly darker, slightly greener, or slightly bluer, but the matches at conversational range are quite excellent. I tell patients that at cocktail party distance, it’s unlikely someone will be able to tell,” he said.
There are two models of the HumanOptics device: a fiber-free and a fiber-containing model. “The fiber-free model is generally injected or placed into the capsular bag or ciliary sulcus if there’s strong capsular and zonular support,” Dr. Miller explained. “It is not supposed to be sutured in place. If you think you’re going to need to suture-fixate a device, which occurs in the majority of cases, then you need to make sure you order the fiber-containing model. We’re all still trying to figure out how to size these. The devices come in a standard diameter of 12.8 mm, and this size seems to work quite well for most eyes when passively placed in the sulcus. But there are small eyes that require trephination. When devices are sutured into the eye, they can be sutured further back, so sizing is not so critical. However, when a device is placed in the sulcus or capsular bag, sizing is truly important.”
He added that the HumanOptics artificial iris is a great choice for all patients with iris defects, with the exception of patients who have a clear crystalline lens. “This device cannot be implanted in front of a clear lens or it will develop a cataract in no time. The patient has to have a cataract or be aphakic or pseudophakic. Surgeons would not want to implant this device in someone who has a very small iris defect that could easily be closed with a suture or two. However, if the defect can’t be closed with sutures because it’s too large and the patient doesn’t have a clear lens, then he or she is eligible,” Dr. Miller explained.
According to Dr. Snyder, the device can be placed within the capsular bag, if it’s being done at the same time as cataract surgery. “That’s an ideal place because anything that’s placed within the capsular bag is not in contact with any living tissue. It’s sequestered within the capsular bag, just like the lens implant. In eyes with no capsular bag or if the capsular bag is not intact, the device can also be sutured and secured to the eye wall,” he said.
The device has been approved for both children and adults. “The functional impact is excellent, the reduction in light-related symptoms is quite excellent, and the reduction in multiple images is excellent,” Dr. Snyder said.

An added benefit

In addition to functional benefits, artificial irises have psychological benefits. “Before surgery, these patients typically just cover the eye by wearing a patch or dark sunglasses all of the time. They do this partly to avoid the light, but they also do it to avoid the stares,” Dr. Miller said. “When you look at someone, you’re naturally drawn to their eyes. Iris defects are especially evident in people who have light-colored eyes. Some of them wear a cosmetic contact lens and that helps a little bit, but even that brings attention to the eye. So one of the huge benefits of this implant is the psychological improvement that patients experience. A lot of them feel normal again for the first time in a long time. Some of these patients have lived with the defect for most or all of their lives. Finally, they can go out into the world and not be concerned with how they look. No one talks about it in any of the papers, posters, and courses, but it’s huge.”
Dr. Snyder agreed. “While it’s not indicated for cosmetic changes, it’s nice for someone who has a damaged iris. These people often feel very self-conscious about it, and it can be a big issue for them,” he said.

Dr. Snyder has financial interests with HumanOptics and VEO Ophthalmics, (Cincinnati). Dr. Miller has no financial interests related to his comments.

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