FDA
TALK PAPER

The FDA has received a number of media inquiries about ColorMax eyeglass lenses, which are being promoted widely as a way to correct color blindness. Some of the claims in these promotions may be misleading.

The following can be used to answer questions:

• ColorMax lenses, made by Color Vision Technologies, Inc., Tustin, Calif., were cleared for market by FDA in November. They are tinted prescription spectacle lenses intended as an optical aid for people with red-green color vision deficiencies. The lenses do not help wearers perceive or appreciate colors as people with normal color vision do, but merely add brightness/darkness differences to colors that are otherwise difficult or impossible to distinguish.



• ColorMax lenses are designed to improve discrimination of specific colors that look the same to people with regreen color deficiencies. However, discrimination of at least some other colors is actually impaired.



• ColorMax lenses are not effective for people who are totally color blind. Very few people are truly color blind, and these lenses will not help them to see colors. Most people with color vision problems have partial color vision deficiencies that make it difficult to distinguish between red and green or between yellow and blue. FDA marketing clearance for ColorMax Lenses is limited to red-green color deficiencies, and does not include yellow-blue deficiencies or total color blindness.



• ColorMax lenses are coated with colored filters using a technology similar to that used to apply anti-reflection coatings on spectacles and colored coatings on prescription sunglasses. The coating process is not new or "high-tech" as stated in some of the company's promotional reports.



• Although ColorMax lenses are the first such lenses to be cleared by FDA for commercial marketing in the United States, the idea is far from new. The use of colored filters as an optical aid for color deficiency has been reported in the scientific literature since the 1850's,and at least two textbooks on color vision deficiencies contain entire chapters on the subject.



• The Colormax lenses were cleared for marketing through the FDA's regular premarket review process. Contrary to reports, no special class of devices was created by FDA for these products.



• FDA has determined that ColorMax lenses are substantially equivalent to prescription spectacle lenses. The manufacturer conducted clinical studies to support a new indication for use as an optical aid for red-green color vision deficiencies.



• FDA is currently looking into the claims being made for this product.