A 37-year-old Illinois truck driver has become the first person in the United States to receive so-called “permanent” implantable contact lenses for the correction of myopia with astigmatism approved by the US Food and Drug Administration (FDA) last month.
On October 22, refractive surgeon Jason P. Brinton, MD, of Brinton Vision in St Louis, implanted the Visian Toric Implantable Collamer Lens (Toric ICL, Staar Surgical) to correct the patient’s vision. The patient was not a candidate for LASIK, according to a news release from Brinton Vision.
On September 13, the FDA approved Staar Surgical’s premarket approval (PMA) supplement for the Visian Toric ICL for the correction of myopia with astigmatism. Toric ICL lenses are implanted behind the iris and in front of the natural lens of the eye.
According to the FDA, the Visian Toric ICL “may improve distance vision and correct or reduce myopia with astigmatism.”
In a clinical study of 210 patient’s eyes implanted with the Visian Toric ICL, 97.4% of eyes achieved within 1.0 D from target refraction and 97.9% of patients had less than or equal to 10 degrees of lens rotation after 1 year, the FDA said.
The most common safety event that occurred during the trial was a second surgical procedure to reposition or to remove and replace the lens, which did not result in any significant loss in vision sharpness. Implantation of the device can be associated with risks of cataract formation, increased eye pressure, and second surgical procedure, the FDA said.
“This approval represents a meaningful expansion of the ICL product line for the correction of refractive error in patients with both myopia and astigmatism which are common conditions in the United States,” the company said in a news release. “The ICL in both spherical and toric designs has been associated with significant improvements in quality of life.”
Prior to FDA approval, Visian Toric ICL had been used successfully in 450,000 people worldwide.
Visian Toric ICL is approved for use in patients aged 21 to 45 years. Indications for use are as follows:
Correction of myopic astigmatism with spherical equivalent ranging from -3.0 D to less than or equal to -15.0 D (in the spectacle plane) with cylinder (spectacle plane) of 1.0 D to 4.0 D in the spectacle plane.
Reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0 D to -20.0 D (in the spectacle plane) with cylinder (spectacle plane) 1.0 D to 4.0 D in the spectacle plane.
With an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 D for both spherical equivalent and cylinder for 1 year prior to implantation).
Visian Toric ICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.
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Cite this article: Newly Approved Toric ICL Implanted in First US Patient – Medscape – Oct 26, 2018.