This article is more than 5 years old. Information may no longer be current.

STAAR Surgical’s Toric ICL receives conditional approval

Issue: February 15, 2002

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

MONROVIA, Calif. — STAAR Surgical (NASDAQ: STAA) has received conditional approval from the FDA for an investigational device exemption (IDE) for the Toric Implantable Contact Lens (TICL). The IDE allows the Company to begin clinical investigation on the TICL in the United States with patients having myopia in the range of –3 D to –20 D and astigmatism in the range of 1 D to 4 D.

The phakic TICL offers treatment for both reduction of pre-existing astigmatism and patients with visual correction for myopia.

Enrollment in the primary FDA clinical trial for the ICL for myopia has been completed. The study demonstrates excellent visual outcomes with low complication rates to date. In a cohort of 529 cases, the incidence of lens opacities was reported to be 2.3% (12 eyes), with eight of these opacities being nonprogressive and showing no loss of best corrected visual acuity.