Laguna Beach, CA—Patients may soon be able to change their brown eyes blue through a quick laser procedure.
StrÅma Medical, a company based in Laguna Beach, CA, has developed a procedure that disrupts the layer of brown pigment in the iris, revealing the blue underneath.
The desire to change eye color has becoming increasingly popular, as evidenced by the demand for new colored contact lens brands and the controversial BrightOcular iris implant.
According to StrÅma Medical, the procedure uses a laser that fires a series of small, computer-guided pulses across the iris to photo-disrupt stromal melanocytes. The energy passes through the cornea and selectively targets the brown melanocytes, leaving the cornea and posterior iris stroma undisturbed thanks to its photo-absorption properties.
The procedure takes less than 20 seconds. The photo-disrupted melanocytes release cytokine proteins molecules into the aqueous humor of the anterior chamber. StrÅma Medical says the cytokine signal recruits macrophages that engulf and digest the photo-disrupted melanocytes as cellular debris.
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The company says that the eyecare professional would determine when the patient would be able to go back to work and drive, but StrÅma Medical says patients should be able to do so shortly after the procedure. The irises will grow darker for the first week or so after the procedure, but they will slowly lighten with the full color change process taking two to four weeks.
StrÅma’s Chairman and Chief Scientific Officer Gregg Homer says the company treated 17 patients in Mexico two years ago, and the company is currently treating 20 patients in Costa Rica and will likely add more. The company also has plans to treat 30 patients in the Philippines.
Dr. Homer says StrÅma will apply for U.S. Food and Drug Administration (FDA) approval shortly after it releases the technology commercially outside of the U.S.
Some eyecare professionals have expressed concerns that the procedure could raise intraocular pressure (IOP), increasing the risk for glaucoma. But StrÅma Medical says that in its human studies to date—although limited thus far—patients remained within normal IOP ranges. Patients’ post-op IOP never rose above pre-op levels, and, in most cases, IOP actually decreased. No adverse events have been reported.
Optometry Times Editorial Advisory Board member Ben Casella, OD, FAAO, says this is the type of elective procedure that the FDA will look at with a very high degree of scrutiny.
"The company claims that the particles liberated from the anterior iris by this procedure are too fine to clog the trabecular meshwork (keeping in mind that pigmentary glaucoma is caused by pigmented cells from the posterior iris being sluffed off into the angle)," he says. "While the logic of their claim makes sense, we would need to see a multitude of longitudinal data before being comfortable with such a procedure in the U.S. (or anywhere for that matter).
Changing the color of the eye means altering tissue that is not subject to the same immune response as other parts of the body often altered for cosmetic reasons, says Dr. Casella.
“Most doctors who have expressed safety concerns have cited pigmentary glaucoma, says Dr. Homer, speaking exclusively to Optometry Times. “Ultimately, of course, the proof will be in the data. Thus far, no data have revealed any pigmentary glaucoma concerns, and we do not plan to release the technology until we have followed 100 to 150 subjects for at least one full year.
“We will begin taking these doctors' remarks more seriously if they review our final clinical data and still have concerns. Until then, these remarks are really just idle speculation,” he says.