The availability of quarter diopters is another unique distinction that Crystalens enjoys.
July 13 /PRNewswire/ -- Bausch & Lomb announced today that it has received approval from the Food and Drug Administration (FDA) to market the Crystalens HD(TM) in quarter diopter steps in the United States.
The company will begin shipping the Crystalens HD in the additional diopter steps on July 16, 2009.
Out of the 56 million patients, the Company estimates that the target market for the lens, based on the range of diopters recommended for approval by the panel, is approximately 8 million people.
The FDA will consider these recommendations as it completes its expedited review of the ICL Pre-Market Approval application for the -3 to -20 diopter range that was submitted on May 8, 2003.
He has successfully treated more than 50 patients enrolled in the clinical study, all with prescriptions greater than -8 diopters, and up to -20 diopters.
I wanted to do LASIK, but it wasn't an option for me because of my poor eyesight and the thinness of my cornea," said Chuck Thompson, a New York City lawyer whose prescription was a debilitating -15 diopters.
The Verisyse lens implant is approved for the treatment of nearsightedness for prescriptions as high as -20 diopters.
and the LASIK surgery patients had a slightly lower level of myopia at an average of minus 9.
We continue to see strong growth in the Visian ICL throughout the world and believe that the newly expanded Visian ICL diopter ranges launched here at ESCRS more than doubles the market opportunity for Visian and allow us to compete directly within the most popular myopic and hyperopic ranges of treatment with LASIK.
His data showed that with less than a 2 diopter offset, on average his patients could achieve 20/20 distance vision and 20/25 near vision.