By Chencheng Zhao

“Underneath every brown eye is a blue eye,” said Gregg Homer, the inventor of the first noninvasive cosmetic surgery that transforms brown eyes to blue by low-energy laser.

The new procedure, known as Stroma, is raising questions about potential side effects from the technique as well the ethics of performing an elective procedure to change eye color for cosmetic reasons.

For years, people have changed their eye color with contact lenses and even invasive surgery.

Now Strōma Medical Corp. of Laguna Beach, California, has developed a new technique to change eye color. The company said it has no plans at present to market the technique in the U.S.

Homer, Strōma’s chairman and chief scientific officer, said 30 patients have been treated so far. He said none of them had suffered any negative effects.

Stroma, from which the corporation takes its name, is a layer of interlaced tissue in the iris. In dark eyes, the stroma often contains pigment granules, while blue eyes and the eyes of albinos lack pigment.

Homer said in the surgery, the patient is seated, resting his chin in a little cup and looking at a tiny light when the laser treats the iris. The natural blue eye is revealed in 30 seconds, sometimes left with a “limbal ring,” the dark pigment around the outer perimeter of the light iris. , which Strōma’s website compares to the attractiveness of green eyes of Sharbat Gula, the Afghan woman featured on the famed cover of a 1985 issue of National Geographic Magazine.

“It is painless, and there is no recovery time. Patients can immediately drive and work.” Homer said. The total color change takes two-three weeks and is permanent.

The procedure is currently in clinical trials and not commercially available anywhere in the world. A release date has not yet been determined.

Homer said the company will treat 100 more patients and follow them for a year before it finally releases the technology. Potential candidates should be 18 and above and are not limited to nationalities or ethnicities.

Initially, the surgery will be used to change eye color from brown to blue–the “simplest and most sought-after color change,” the company said. It will soon begin testing dark brown to light brown color change, as well as changing hazel or green to blue, which is more complicated and unlikely accomplished with the current laser.

Dr. Kamran Riaz, director of refractive surgery in the Department of Ophthalmology and Visual Science at the University of Chicago, raised some issues.

“I have strong concerns that the risks of this procedure will significantly outweigh any real or imagined benefits,” Riaz said. “I am extremely concerned about the advertising on the company’s website that seems to suggest that not having blue eyes is simply a matter of ‘extra pigment’ that can easily be removed.”

He stated his concern about potential risks and harms that can come about with the procedure, such as the destruction of naturally occurring iris pigment that can cause significant inflammation, ocular damage, elevated pigmentary glaucoma and excessive light sensitivity that could, in turn, be potentially disabling.

Pigmentary glaucoma arises from large pieces of pigments dislodged by abrasion, which increases eye pressure.

Homer said that pigmentary glaucoma had not proved to be a problem so far.

Strōma, he said, uses a low-energy laser to disrupt a thin layer of brown pigment covering the front surface of the iris, initiating a gradual tissue-removal process through which the body digests and eliminates the treated pigment. He said the laser breaks the pigments into the microscopic particles that are small enough for the body to remove.

Riaz noted that the U.S. Food and Drug Administration would have to approve the procedure if marketed in the U.S.

But Homer said he did not plan to pursue FDA approval in the U.S. until next year. Instead, he expected Strōma to seek the CE (Conformité Européenne, meaning European Conformity, a symbol of free marketability in the European Economic Area) this year. This would allow him to release the technology in all countries other than the U.S.

Homer is a researcher and will not treat patients. Strōma stressed it will not perform the procedure on any patients, but will train and certify independent physicians to perform it. The company said these doctors would also set their price. However, it anticipates the retail price of the procedure in the U.S. will be around $5,000.

Some doctors are skeptical about such cosmetic techniques.

Mark Sheldon, an ethicist at Rush University Medical Center in Chicago, pointed out that cosmetic surgery is “elective” or voluntary. “My own feeling is that surgery should only be undertaken if there is no other choice,” he said.

He suggested people distinguish between plastic surgery that focuses on reconstruction following burns and other wounds, and cosmetic surgery that surgeons advertise in magazines.

“They speak to women’s insecurities. They promise a younger, more attractive, self. These cosmetic surgeons advertise directly to the public. They are ‘selling’ things, not responding to circumstances of human beings who are dealing with illness, disease and suffering. They lie outside regular medicine. I would say that these cosmetic surgeons don’t actually have ‘patients.’ They have ‘clients,’” Sheldon said.

Homer thought the ethicist is entitled to his view, but considers it an extreme position. “There is always ‘another choice,’ which is to have no cosmetic enhancement at all. That seems like more of a personal decision than an ethical issue,” he said. He argued that under this ethicist’s view, there would be no hair transplants because of the non-surgical toupee option, liposuction (girdles), breast implants (padded bras), laser skin resurfacing (makeup), or LASIK (glasses).

Finally, Homer emphasized that Strōma candidates don’t have an acceptable non-surgical option because the translucence of a natural blue eye can only be achieved by removing the brown pigment. “Covering the brown with a contact lens or iris implant creates an opaque blue eye, which does not exist in nature and will always look fake,” Homer said.