NEW
ORLEANS — Patients who are interested in receiving cosmetic iris implants to
change the color of their eyes need to be educated on the ocular complications
associated with the implants, according to a speaker here.
“[The
implants] are heavily marketed, these are very savvy presented on the Internet,
and there’s a lot of misleading information about FDA-approved material and
U.S. patent studies. Of course there are no studies,” Tal Raviv, MD, said at
Cornea Day preceding the American Society of Cataract and Refractive Surgery
meeting. “And the reality is this causes such horrific damage.”
The two
major brands of iris implants are New Color Iris and BrightOcular.
There
were more than 700 patients implanted with the New Color Iris implants in
Panama from 2006 to 2010.
In a
study Raviv and colleagues conducted in 2012, more than 50% of patients who
received the New Color Iris implants needed secondary surgery and sometimes
multiple surgeries.
“There
are severe and irreversible complications. This is not a reversible procedure.
It’s just a removable implant,” he said. “The problem with these implants is
that we cannot size them, and they are anterior chamber lenses that basically
touch the angle 360° and cause severe damage.”
If the
patient is showing early signs of iritis, high IOP, pupil ovalization under the
implant, corneal decomposition or cataract, Raviv recommended that the surgeon
should immediately explant the iris implant.
“Do not
delay and do not hesitate to tell the patient that this is extremely
dangerous,” he said.
Primary
explanation should be performed without other secondary procedures. After
explantation, patients should be evaluated to decide if phacoemulsification,
Descemet’s stripping endothelial keratoplasty, glaucoma surgery or iris repair
is needed, Raviv said.
For
explantation, Raviv recommended surgeons use a one-cut removal technique, which
consists of placing Miochol (Bausch + Lomb) in the eye, using 23-gauge graspers
and scissors to make one radial cut into the implant close to the corneal
entry, and removing the implant using an ophthalmic viscosurgical device.
“These
are unapproved, unstudied cosmetic iris implants, and they are truly a public
safety hazard,” Raviv said. “I believe that ophthalmic societies need to
officially condemn these implants.
Nhu Te
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