intraocular lenses

[BUTTERCUP109]

In your opinion, based on your experience, why did the FDA approve Crystalens only for patients over the age of 50?

[Michael J Kutryb, MD]

Most patients with cataracts are over 50 so that is who the clinical trials were done on.  You can still talk to an experienced crystalens surgeon if you need cataract surgery and are under 50.  Some surgeons still use lenses "off label" for those not officially in the approved catagory.  Keep your expectations well in line though as these lenses are somewhat unpredictable and may not provide as much near vision as you want.

MJK MD

[JodieJ]

Hey, Buttercup109, I just saw your subsequent post, and I guess that (unfortunately, in your case) you already have the Crystalens and many problems related to it.  I wish I had some words of wisdom for you.  In your place, I'd seek out the best retinal specialist in the area (or maybe even the region).  Hope your problems are soon resolved.

[JodieJ]

The Crystalens would probably be fine for people under 50 unless they have large pupils.  Because of its smaller optic, people of any age with large pupils would be prone to experiencing glare and halos with the Crystalens.  If you're considering this lens for yourself, a surgeon who is experienced with it could assess whether you are a good candidate.

[2ndsight]

actually I found the labelling and Jodie is right, it says that "safety and efficacy has not been evaluated in patients under age 50" meaning it was not tested on people under 50

[2ndsight]

I am not completely sure of this but from what I read, I think the over age 50 requirement is for patients having "clear lens exchange" in other words, patients who do not have cataracts but want the lens to correct their vision.

[JodieJ]

Probably only patients over the age of 50 participated in the clinical trials.