Issue: March 2012
April 11, 2012
3 min read
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Prosthetic implant to alter eye color may be harmful

A device implanted by surgeons in Panama City, Panama, to cosmetically change natural color of the iris may be associated with sight-threatening adverse effects.

Issue: March 2012
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J. Bradley Randleman, MD
J. Bradley Randleman

A synthetic prosthetic implant used for cosmetic eye color change may be unsafe, with complications including corneal decompensation, cataract formation and vision loss, according to a literature review.

NewColorIris implants (Kahn Medical Devices), developed in 2004, have been associated with a bevy of acute and chronic adverse effects. Surgeons in Panama City, Panama, insert the implants, which are not approved by the U.S. Food and Drug Administration, and promote them as a safe alternative to colored contact lenses.

“I am not a huge advocate of the colored contact lenses, but they are definitely safer than the NewColorIris implant. This device can cause irreversible damage that can and has led to blindness,” J. Bradley Randleman, MD, associate professor of ophthalmology at Emory University and editor-in-chief of the Journal of Refractive Surgery, said in an interview with Ocular Surgery News.

Complications may be managed medically if explantation occurs early, Dr. Randleman said. However, long-standing presence of the device can lead to irreversible ocular changes and permanent damage requiring surgical intervention.

“This device is marketed as being reversible, meaning that if you have it implanted and you develop complications, it can be removed, with your eye returning to normal. But that is simply not the case,” Dr. Randleman said. “That is equivalent to saying that getting shot with a gun is reversible if you take out the bullet. Yes, you can take out the bullet, but everything that bullet hit along its path is still damaged.”

Complications

The primary complication of NewColorIris implants is corneal dysfunction or decompensation of the corneal endothelium, which may lead to corneal edema and eventual transplantation, Dr. Randleman said. Inflammation is a common early postoperative problem, potentially causing glaucoma or IOP-related issues. Moreover, because of the device’s location, repeated eye rubbing could result in cataract formation.

“Every structure in the anterior segment of the eye can be damaged,” Dr. Randleman said.

Image of the NewColorIris implant in the anterior chamber.
Image of the NewColorIris implant in the anterior chamber. A small amount of the patient’s natural brown iris is visible along the pupillary margin.
Slit beam image of the cornea demonstrating visually significant corneal edema resulting from the NewColorIris implant.
Slit beam image of the cornea demonstrating visually significant corneal edema resulting from the NewColorIris implant.
Image: Randleman JB

A literature review published in Clinical Ophthalmology by Sikder and colleagues discussed eight cases of complications in 16 eyes reported in articles listed on PubMed and another case of two eyes observed by the authors directly. Seven of the nine cases showed symptoms within the first postoperative month.

Only one patient required explantation due to uveitis and ocular hypertension, but all complained of decreased or blurred vision and demonstrated anterior chamber inflammation. At final follow-up, 56.25% of the 16 eyes reported in prior studies had decreased best corrected visual acuity, the same percentage with sub-optimal BCVA at initial presentation.

Corneal edema occurred in 81.25% of the 16 eyes, and 75% experienced elevated IOP. In addition to explantation of two implants in a single patient, three trabeculectomies, two Descemet’s stripping automated endothelial keratoplasties and three peripheral iridotomies were also performed.

“With its current design, implantation should be seriously deliberated and risks such as possible surgery for cataracts, elevated IOP and explantation should be extensively discussed with potential patients,” study authors wrote.

While it is impossible to estimate the extent of complications due to the unknown number of devices implanted, numerous videos on YouTube add to published examples.

Potential explanations

Several reports identified manufacturing defects that could harm the ocular surface, according to the study authors.

“In one such study, scanning electron microscope images revealed surface irregularities and sharp edges that may contribute to the abrasion of the corneal endothelium and iris,” they wrote.

Moreover, the authors noted that other studies have demonstrated the implant’s tendency to contact angle structures directly and shift position over time. Some reports also highlighted improperly sized implants that exhibited vaulting within the anterior chamber.

“Specific measurements of each individual patient’s anatomy may permit custom sizing of the implant in the future, with decreased associated risk of complications,” the study authors wrote, adding that steps should be taken to select appropriate candidates for implantation. No criteria for candidacy currently exist.

According to Dr. Randleman, NewColorIris implantation differs from many other cosmetic procedures in that it may damage surrounding anatomical structures and lead to lifelong problems that otherwise would not occur.

“It preys upon younger patients usually and people who may be a little more self-conscious about their appearance, and it promises something that it cannot deliver, and it minimizes the severity of the risk involved,” he said. – by Michelle Pagnani

Reference:

Sikder S, Davis SW, Holz H, Moshirfar M. Complications of NewColorIris implantation in phakic eyes: a review. Clin Ophthalmol. 2011;5:435-438.

For more information:

J. Bradley Randleman, MD, can be reached at 875 Johnson Ferry Road, Suite 100, Atlanta, GA 30342, U.S.A.; +1-404-778-2264; email: jrandle@emory.edu.

Disclosure: Dr. Randleman has no relevant financial disclosures.