April 2017




Controversies in cataract surgery
Status of artificial iris implantation devices in the U.S.

by Ellen Stodola EyeWorld Senior Staff Writer


An example of the HumanOptics silicone custom artificial iris
Source: Samuel Masket, MD

Physicians discuss artificial iris devices and their use

Currently in the United States, there are no Food and Drug Administration (FDA)-approved artificial iris devices. However, one of these devices is part of a clinical trial in several locations around the country. Michael Snyder, MD, Cincinnati Eye Institute, Cincinnati, and Samuel Masket, MD, Advanced Vision Care, Los Angeles, discussed artificial iris implantation, the status of these devices, and their own experiences using them in the clinical trial.
Currently, there are four manufacturers of artificial iris devices globally: Morcher (Stuttgart, Germany), Ophtec (Groningen, Netherlands), HumanOptics (Erlangen, Germany), and Reper (Nizhny Novgorod, Russia). The HumanOptics device is currently undergoing FDA trial, Dr. Snyder said.
Though the PMA arm of the study has been fully recruited, Dr. Snyder said that physicians participating in the trial are still able to continue enrolling patients through a continuing access arm. “It is our hope that the device will become available through the FDA process on a more widespread basis,” he said.
Currently, the only option for an ophthalmologist with a patient who needs artificial iris implantation is to refer the patient to one of the FDA-approved sites in the investigation, Dr. Masket said. His practice is one of those sites, and the others are dispersed around the country. Dr. Masket said that he has seen patients from the West Coast, the central part of the country, and outside the US.
One stipulation in the investigation is that postoperative visits also need to be at the study center, Dr. Masket said. This includes a follow-up appointment at 1 day, 1 week, 1 month, and at 3, 6, and 12 months. It’s quite remarkable, he said, how compliant patients have been with these follow-up appointments. The patients seem to recognize the significance of the investigation. “It really is a transformative experience when the defective iris is replaced,” he said.
The original cohort of the study was 180 eyes, Dr. Masket said. That was filled, but the FDA has allowed continuing access, he said, making it possible for sites to continue to enroll patients.

Surgeon preparation for device approval

There are a number of ways surgeons can prepare for approval of this artificial iris device. When you talk about adding new technology to your armamentarium, Dr. Snyder said, you have to consider how to obtain the device and how to technically put it in.
Procuring the device involves a number of specific logistics, he said. The device is created based on an index photo. “Whenever we use the devices, we have to obtain a high-quality color photograph from the unaffected eye from which the device is made.” Basically, you take a picture of the unaffected eye, and the manufacturer then crafts it to make as close a match as possible to the index photo, though Dr. Snyder noted that when looking through the slit lamp, you can sometimes notice slight differences. Not only is each custom colored, but the surface of the device is molded to have a texture similar to anterior iris, he added.
These artificial iris devices perform very well in reducing light sensitivity, contrast sensitivity, glare, and halos, he said.
Another important factor for surgeons to prepare for is the technical aspect of how to insert the device. There is a learning curve because these are maneuvers that are not common in normal daily activity, Dr. Snyder said. The ASCRS has established an artificial iris wetlab that has been run at the annual meeting in the past and will be on the program again this year, he said. This allows physicians to use all of the devices to get a better understanding of them. This is “probably the best way at this moment to become comfortable with implantation technique,” he said.
Another valuable component is to start thinking about the device whenever doctors see a patient who has some sort of iris affliction, Dr. Snyder said. It’s important to reflect on who may benefit from this technology. There are some patients, Dr. Snyder said, for whom you might be able to use stitches or stretch the iris tissue to create adequate aperture. But sometimes, when a lot of those maneuvers are required, a patient could be better served with an iris device placed in the capsular bag during cataract surgery. That could be quicker, safer, less risky, and with a better cosmetic result, he said.
Dr. Snyder said that he expects that if and when the device is approved by the FDA, there will likely be certain indications for on-label use. As physicians, there is an obligation to patients to determine if that device is going to be useful to them. He noted that the FDA labeling will likely also depend on which patients with certain conditions may have been included in study data. Certain situations may arise that were not represented in study data, he added.
Typically the decision-making for when to use the device is based on how much of the patient’s existing iris remains, whether it would mend itself based on the amount that remains, and whether the strength of iris tissue would hold sutures, Dr. Masket said. The other decision-maker, he said, is the cosmetic aspect. If the patient has a dark iris and the physician can do an adequate functional repair, that could be acceptable. For someone with a light iris, suture repair may not have same aesthetic value, he added.
To prepare inserting these devices, Dr. Masket said it’s important to brush up on certain skills. “All of the techniques we use to implant these devices are things that surgeons have done before, just maybe not in that particular order,” he said, recommending that physicians go to lectures and courses at national and international meetings. Dr. Masket said that the hope is that the device will be approved by the end of 2017. Once approved, courses will be organized to teach surgeons how to do the procedure, he said. “Everything is in the skill set of an accomplished anterior segment surgeon, it’s just a question of logistics,” he said.

Potential concerns

As with any device, there are potential concerns with artificial iris devices. “The kinds of eyes that require an artificial iris implantation are not an overly healthy group of eyes,” Dr. Snyder said.
If the device is fixated by natural support structures and these become inadequate, then the device could possibly have to be re-secured, Dr. Snyder said. The best way to treat that is with prevention and ensuring good fixation from the start, he said.
Doctors must recognize that no normal eye ever needs an artificial iris, Dr. Masket said, so many of these eyes have comorbidities specifically relating to glaucoma or damaged corneas. Managing comorbidities becomes a big problem and may require further surgery after artificial iris implantation, Dr. Masket said. “The reason we’re investigating is to determine associated problems with the device,” he said.
Dr. Masket said that in his experience, device-specific problems are very rare. This is a “huge game changer,” he said, and has made a difference for many patients. Another detail that Dr. Masket noted is that patients must pay for the device, as it is not covered by insurance. This can be quite expensive, Dr. Masket added. Accordingly, he developed a non-profit foundation (www.masketfoundation.org) to help disadvantaged patients bear the expense of participating in the investigation.

Editors’ note: Dr. Snyder has financial interests with HumanOptics. Dr. Masket has no financial interests related to his comments.

Contact information

: avcmasket@aol.com
Snyder: Msnyder@cincinnatieye.com

Status of artificial iris implantation devices in the U.S. Status of artificial iris implantation devices in the U.S.
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