Man's New Iris Implant Turns Black Eye Blue

April 7, 2010— -- Charlie Haverstick was 26 when a mishap during a friendly game of flag football changed not only his eye color, but his vision.

"I was running out to catch or intercept the ball," said Haverstick. "One of the receivers from the other team came toward me and hit me in the eye with the ball of his hand like a karate chop."

The blow broke the bone behind Haverstick's eye. He suffered a subdural hematoma, or bleeding in the brain. The injury also tore the muscle of the iris in his right eye.

But most surprising was that Haverstick, previously blue-eyed, emerged from the week-long hospital stay with one blue eye and one, his right, which had turned completely black.

"People think I have a brown eye and a blue eye," said Haverstick.

The injuries were more than cosmetic. Although he could still see, his permanently damaged iris could no longer act as a shutter, limiting the amount of light entering his right eye. He became extraordinarily sensitive to light.

In photographs, his dark eye appears a bright "Terminator-like" red because nothing blocks the light that reflected off the retina in the back of his eye.

"In natural daylight the size of the pupil might be two millimeters," said Dr. Kevin Miller, an ophthalmologist at UCLA's Jules Stein Eye Institute. "He has essentially no iris, so his functional pupil size is 12 millimeters or 12.5 millimeters, so light just comes pouring into the eye."

Living without an iris is not unheard of. About 1 in 50,000 to 100,000 newborns have a congenital defect that results in aniridia -- an absent or partial iris. An unknown number of others damage the iris through injury. Most treatments focus on limiting the light that comes into the eye, but don't consider the cosmetic aspect of the eye color.

Last month, Haverstick became only the 29th person in the United States to undergo a custom artificial iris implant that aims to address both concerns.

Haverstick, now 53, who lives in Inola, Okla., is a computer instructor at a private college and a coach for a swim team. He tries to limit his exposure to computer screens and wears sunglasses even on the cloudiest days. While attending a clinic on animal ophthalmology, Haverstick's veterinarian heard about a Los Angeles surgeon who was doing human iris transplants. Haverstick called and set up an appointment almost immediately.

Iris Implant Means More Natural Appearance After Injury

"Now I've got an opportunity to be able to go outside without having to shield myself, like a vampire," he said, "and to be able to walk around without worrying too much about getting the headaches at the end of the day."

Miller has performed 70 iris transplants, but none corrected the cosmetic appearance; they simply "appeared spooky." He is only the second surgeon in the United States to implant an artificial iris that is custom-made. Haverstick was his first patient to get an artificial iris that also restored his eye color.

The iris is created by HumanOptics AG, a company with headquarters in Erlangen, Germany. The first of this type of implant procedure was performed in November 2002 in Bonn, Germany. A surgeon in Cincinnati has implanted 28 of these devices. There are about 250 patients worldwide who have had the procedure.

The artificial iris is made of silicone. German artisans refer to a photograph of a patient's good eye and paint an exact replica onto the flexible silicone wafer. Then they encase that artificial iris in more silicone so the pigments don't leach out.

The device is not in clinical trials or even approved for use in the U.S., so Miller applied for a "compassionate use" exemption from the Food and Drug Administration, a process which took three months. It took another six weeks for the company to manufacture and ship three versions of the painted silicone wafer: one a perfect match to his left eye and two others which were darker and lighter. Cost of the device: more than $5,000.

Haverstick does not have health insurance and is relying on family and friends to help pay for the procedure. The transplant itself cost about $8,000. Typically, insurance plans do not cover devices which are not FDA approved.

The surgery itself took less than an hour. Miller made an incision into the cornea – the clear part of the front of the eye -- rolled up the flexible wafer like a cigar and inserted it, then unrolled it flat.

Unlike a normal iris whose pupil adjusts to different levels of light, the artificial iris has a fixed diameter.

Iris Implant May Get FDA Approval in Future

"It's not the six million dollar man," said Miller. "It's not bionic and it doesn't open and close. But I think it's going to be a huge evolution in the treatment of patients with missing iris tissue."

At his post-op appointment the next day, Miller removed the large patch over Haverstick's right eye.

"It's a really nice color match," said Miller, who led his patient over to the mirror to see for himself.

"Wow," said Haverstick. "You know when I first had the injury I would stare at the mirror like this and think my eye was working, but it wasn't."

He looked at Miller with eyes that were the same color for the first time in 27 years. "That is really a good job. Thank you."

Haverstick turned around to show his mother and sister, who were both wiping away tears.

"You can't tell it's not a real iris," said his sister Susan Haverstick. "It looks exactly like the other iris. It's gorgeous. I'm really happy for him."

After a second post-op appointment in about a week, Haverstick will return to his family in Oklahoma. He has three daughters. The oldest was two when her father was injured; the others were not even born. They have always remembered him with two different colored eyes.

"I can't wait to get home and show them," said Haverstick.

Miller will be speaking with ophthalmology colleagues to begin clinical trials with the custom artificial iris device and hopes to get FDA approval within 5-6 years.

"People are always looking to change cosmetic appearance," said Miller. "I don't think this is a procedure to change eye color. This a baby step in the direction of helping people with a significant medical problem. You never know what the cosmetic ramifications will be as time goes on."