Aa
Aa
A
A
A
Close
Avatar universal

Why FDA website can post untrue statement about Ortho-K

http://www.fda.gov/CDRH/contactlenses/types.html#rgp
http://www.fda.gov/fdac/features/1998/298_lens.html
“The vision correction effect is temporary. If Ortho-K is discontinued, the corneas will return to their original curvature and the eye to its original amount of nearsightedness. Ortho-K lenses must continue to be worn every night or on some other prescribed maintenance schedule in order to maintain the treatment effect. Your eye care professional will determine the best maintenance schedule for you.”

On above statement, FDA says "the corneas will return to their original curvature and the eye to its original amount of nearsightedness."
Based the reading from the site and other sites, this statement is untrue because the ortho-k can persistently reduced the thickness of the cornea and caused the persistent corneal shape change. Here I use "persistent" because there is no way to approve this is permanent because the patients can not wait for a life time (they may wait 6 month or a year) and they have to use other surgery to fix the problem that occurred after wearing the Ortho-K.
I also am confused where FDA gets such statement because I read several package insert, the companies never this way although I can the same statement from the media or newspaper.

So, what we should do? This already caused the misleading and the misleading caused eye injure (people believed such statement and wore such lens; finally the cornea thickness became thinner lower than normal and also the corneal shape changed irregularly).

We can file a complaint on FDA Medwatch for the company problem. For FDA own problem, what we should do?










This discussion is related to Vision Shaping Treatment - when and why?.
5 Responses
Sort by: Helpful Oldest Newest
233488 tn?1310693103
MEDICAL PROFESSIONAL
-
Helpful - 0
Avatar universal
Are you saying that Ortho-K caused you to have permanent corneal damage?  But the FDA statement fails to warn consumers about this danger by stating that changes to the cornea are only temporary?  
Helpful - 0
233488 tn?1310693103
MEDICAL PROFESSIONAL
60 years of clinical reseach by ophthalmologists and 60 years of false self-serving pseudo-research by the optmetric trade.

JCH MD
Helpful - 0
Avatar universal
You said that "The FDA is absolutely correct". But based on what?
More confused. Thanks.
Helpful - 0
233488 tn?1310693103
MEDICAL PROFESSIONAL
The FDA is absolutely correct. Ortho-K is like trying to get a really good figure by wearing a girdle over night and then expecting the figure to be permanently changed in the morning when its removed, or trying to reduce your waistline by sleeping with a tight belt on. Ain't going to happen.

Ortho-K is older than the hills, been around for probably 60 years and the only people that believe in it are the optometrists that keep shilling it.

JCH MD
Helpful - 0
Have an Answer?

You are reading content posted in the Eye Care Community

Top General Health Answerers
177275 tn?1511755244
Kansas City, MO
Avatar universal
Grand Prairie, TX
Avatar universal
San Diego, CA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Popular Resources
Discharge often isn't normal, and could mean an infection or an STD.
In this unique and fascinating report from Missouri Medicine, world-renowned expert Dr. Raymond Moody examines what really happens when we almost die.
Think a loved one may be experiencing hearing loss? Here are five warning signs to watch for.
When it comes to your health, timing is everything
We’ve got a crash course on metabolism basics.
Learn what you can do to avoid ski injury and other common winter sports injury.