February 2019

CORNEA

Device focus
Update on artificial iris implants


by Michelle Stephenson EyeWorld Contributing Writer


This patient suffered an accidental knife injury to his left eye when he was 10 years old.
The injury resulted in a corneal laceration, damage to the iris, and a traumatic cataract.
He underwent emergency surgery to close the globe and remove the cataract. He was left aphakic and partially aniridic, and he developed a corneal scar. He underwent retinal detachment repair by the scleral buckle technique shortly thereafter. High intraocular pressure was treated medically. He also developed a sensory exotropia.

This patient underwent penetrating keratoplasty, posterior synechiolysis, removal of residual cataract material, anterior vitrectomy, and scleral suture fixation of a posterior chamber
intraocular lens and HumanOptics artificial iris. At the time these photographs were taken,
he was recovering from strabismus surgery.
Source (all): Kevin Miller, MD

Dr. Miller shares insights on these devices

The HumanOptics (Erlangen, Germany) artificial iris implant was approved by the FDA in May 2018 and became commercially available in October.
According to Kevin M. Miller, MD, Los Angeles, only approximately 20 surgeons who were involved in the clinical trial are currently implanting the device. “To be a commercial implanter, surgeons need to demonstrate that they have significant experience with complex intraocular surgery, and they must have performed a certain number of lens exchanges and vitrectomies,” he said. “These surgeons cannot be newbies in intraocular surgery because these are reasonably difficult cases. The eyes that need these devices are not clean eyes, so surgeons will have to document that they have certain clinical experience, and they’ll have to go through a training phase where they’re asked to suture devices into model eyes.”
Additionally, CPT codes for the device have not yet been established, so it is currently not covered by insurance. “This is probably going to be a several-year process,” Dr. Miller said. “In most clinical trials, the device manufacturer provides the device for free and pays for all study-related activities. But that would have bankrupted HumanOptics because they are a small company. So everything was done by the investigators for free, including the surgeries to implant the devices. We just billed out the covered portion of the surgical procedure. Today, patients pay for the artificial iris out of pocket.”

Cosmetic and functional benefits

Artificial iris implants have both cosmetic and functional benefits for patients with congenital or acquired iris defects. Most patients who would benefit from an artificial iris have suffered either surgical trauma, which is rare, or blunt or penetrating injuries.
According to Dr. Miller, the only patients with iris defects who are not candidates for an artificial iris are those with a clear lens inside the eye. “We don’t sacrifice clear lenses to implant artificial irises. Patients must either have a cataract or be aphakic or pseudophakic to be a candidate. If an iris defect can’t be closed with sutures because it’s too large and the patient doesn’t have a clear lens, that patient is eligible,” he explained.

Pearls for implantation

Dr. Miller said that pearls for implantation are unique to each case. “Approximately one-third of these patients have glaucoma, and many have tubes in their eyes. About a third have already undergone a corneal transplant,” he said.
The HumanOptics device is available in two models. One is fiber-free, and the other is fiber-containing. “With the fiber-free model, we generally inject it, and we place it in the ciliary sulcus if there’s good capsular and zonular support. This model is not meant to be sutured. If you think you’re going to need to suture-fixate the device, which will be the case for the majority of eyes, then you will need to make sure to order the fiber-containing model,” Dr. Miller explained.
The device comes in a standard diameter of 12.8 mm, which seems to fit well into the sulcus of most eyes without trephination. “However, we also operate on small eyes, for which we will need to trephine the iris diameter. Unfortunately, we don’t have consensus on how to best size these yet. It’s kind of like the early days of the implantable contact lens and the sizing issues we experienced then. When you suture the device into the eye, sizing is not so critical. However, when you place the device in the sulcus, sizing is critical,” he said.

The future

Two other artificial iris devices have undergone clinical trials. “Years ago, Ophtec [Groningen,the Netherlands] ran a clinical trial of a combination iris and lens device called the Ophtec Model 311 device. The overall results of the Model 311 were good, but the device never ended up on the market for one reason. When the company presented their data to the FDA, the FDA wanted to see where Ophtec was manufacturing the raw materials from which the devices were made. Ophtec had warehoused a lot of material, but the plant that manufactured the raw materials had been closed for years. The FDA said if they couldn’t inspect the plant, they couldn’t approve the device. We had data with these devices sitting inside a patient’s eye, but that wasn’t good enough,” Dr. Miller said.
Another device that has undergone clinical trials is made by Morcher (Stuttgart Germany). Ophtec and Morcher were the first companies to develop artificial iris devices. “I became interested in Morcher devices years ago for select patients who had specific iris needs. This company makes a variety of devices that accommodate different needs. Individual surgeons around the country were petitioning the FDA to get single-use compassionate device exemptions, and the FDA was giving them the OK. Then the FDA told Morcher that they would not approve them anymore and that Morcher needed to do a clinical trial. Morcher declined to start a clinical trial because they thought it would be too expensive. I asked Morcher if I could run a clinical trial through my practice, and they agreed. Over the last few years we have published several papers regarding our experiences with Morcher implants,1,2,3,4,5 and we are hoping to go to the FDA in 2019 for a guidance meeting to get the FDA’s perspective on what else we need to do to get this out on the market commercially. My hope is that this will happen in the next 3–5 years,” he said.

References

1. Olson MD, et al. Interim results of a compassionate-use clinical trial of Morcher iris diaphragm implantation: report 1. J Cataract Refract Surg. 2008;34:1674–80.
2. Date RC, et al. Outcomes of a modified capsule tension ring with a single black occluder paddle for eyes with congenital and acquired iris defects: report 2. J Cataract Refract Surg. 2015;41:1934–44.
3. Miller KM, et al. Outcomes of implantation of modified capsule tension rings with multiple black occluder paddles for eyes with congenital and acquired iris defects: report 3. J Cataract Refract Surg. 2016;42:870–8.
4. Lin SR, Miller KM. Lessons learned from implantation of Morcher 50D and 96S artificial iris diaphragms. Case Rep Ophthalmol. 2017;8:527–534.
5. Miller KM, et al. Safety and efficacy of black iris diaphragm intraocular lens implantation in eyes with large iris defects: report 4. J Cataract Refract Surg. 2018;44: 686–700.

Editors’ note: Dr. Miller has no financial interests related to his comments.

Contact information

Miller: miller@jsei.ucla.edu

Update on artificial iris implants Update on artificial iris implants
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