Safety outcomes of an investigational angle-supported phakic lens for moderate to high myopia: 5 year results for second eyes

Session Details

Session Title: Posterior chamber Phakic IOLS for correction of Myopia

Session Date/Time: Monday 15/09/2014 | 08:00-10:30

Paper Time: 09:11

Venue: Capital Hall B

First Author: : A.Maxwell USA

Co Author(s): :                  

Abstract Details

Purpose:

To assess long term safety outcomes of an angle-supported phakic lens for the correction of moderate to high myopia

Setting:

3 open-label trials in U.S. (C-02-23), Europe (C-02-40), and Canada (C-02-21).

Methods:

In a prospective, integrated analyses at 5 years: 360 subjects (>18 years of age) underwent implantation of an AcrySof Cachet Phakic Lens. Study exclusions were previous corneal or ocular surgery, history of glaucoma, any type of cataract, >2.0 D of preoperative corneal astigmatism, and mesopic pupil size >7.0 mm. Second-eye outcomes at 5 years postoperative included mean annualized percentage change in endothelial and peripheral cell density (ECD) since the 6 month postoperative visit and cumulative serious adverse events (out of 155 operations).

Results:

Mean annualized percentage change (± standard deviation) in central ECD was 1.6±2.1% (n=87; range, -14.4% to 2.5%). Mean annualized percentage change (± standard deviation) in peripheral ECD was -1.8±2.6% (n=87; range, -15% to 3.2%). Serious adverse events did not include IOL related secondary surgical intervention (0/155), but did include synechia (6/155), cataract formation (1/155), and pupil ovalization greater than 1.0 mm (1/155).

Conclusions:

Safety outcomes assessed at 5 years postoperative to second-eye implantation of the investigational AcrySof Cachet Phakic Lens revealed promising safety outcomes and ECD changes within acceptable limits.

Financial Interest:

One or more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One or more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented