I am curios as to what happened to the FDA approval of the Staar phakic iol. Also if there are any other improvements to the current lens available that are proposed to be coming out in the near future?

Are they still mainly recommended for people with over -10 diopters?

Last I heard this lens finally got an "approvable" designation from the FDA and should be available very, very soon. I have already been implanting the other phakic IOL (the Verisyse) with great success. Yes, in general these lenses are best for prescriptions over -11 diopters but there is some overlap depending on such things as pupil size, corneal thickness, corneal shape etc.

Dean Dornic, MD

I heard this IOL works well with large pupils. What diameter sizes does this IOL come in? What pescriptions does it come in as well? Does it work for hyperopes and astigmastim?

I'm a (small) investor in Staar and a prospective customer. Approval of the myopia ICL is imminent; we all hope by the end of the year, although the FDA is difficult to predict. It was submitted for approval down to -3 diopters up to -20. In conference calls, Staar has been reporting that the average power implanted has been decreasing to the -7 to -8 range. So some docs in Canada, Europe, and Korea (where it is already approved) have been using it for moderate myopes who might otherwise be Lasik candidates. It will be interesting to see whether it displaces Lasik for this population in the US.

Shortly after approval of the myopia version, Staar will submit for follow-on approval of a toric version that will treat myopia and astigmatism at the same time. If all goes well, that approval is perhaps 6-9 months out. I don't know what their schedule is for hyperopia.

The Visian ICL is approved in Europe, Canada, and Korea in myopia, hyperopia (except Korea) and myopic astigmatism versions. Further details on approved powers and optical diameter are available on the Staar website at www.staar.com. Enter the International site and click on "refractive."

Just to update - the Staar Visian ICL was approved today, and should be shipping within 6-8 weeks. Docs will have to be trained (many have already gone through it) and proctored for their first 5 surgeries before they can perform the procedure solo. No word on toric version for astigmatism - a good guess would be 6-9 months. It was approved for treatment of myopia -3 to -15 diopters and reduction of myopia -15 to -20, ages 21 - 45.

A press release from STAAR is available at http://www.usaeyes.org/library/visian.htm