Will Synchrony Get FDA Approval This Year?

Presbyopia and cataract sufferers look for a vision solution that can save them from the burden of reading glasses. Although LASIK is a great solution for many vision problems, its only solution for presbyopia (monovision) is not a very good one. For many years the most promising avenue was multifocal IOLs, which replaced the eye's accommodating lens with one whose multiple focal zones allowed recipients to see at different distances. But multifocal lenses have a number of problems. The most common complaint about multifocal lenses is the starbursts, haloes, and other vision effects caused by light passing through focal zone boundaries.

Another solution is a lens that accommodates (changes focus) like your natural lens. There is currently only one accommodating lens approved by the FDA, Crystalens. Crystalens is a good option, but the amount of correction it gives is limited and it has been associated with a high incidence of opacity of the capsular bag that contains the lens, which requires a follow-up procedure called a capsulotomy. Now, industry experts say a second accommodating lens with the potential to solve these problems may be approved this year.

Crystalens has a single lens that moves forward and back as they eye's ciliary muscles flex. Synchrony uses a dual system of lenses that change configuration in response to ciliary muscle action, allowing a person to focus on objects at different distances. According to pre-approval studies, Synchrony offers as much as 4 diopters of correction, enough to give about 90% of recipients 20/20 or better vision and full functionality at all distances after surgery. Comparison with the multifocal lense ReSTOR showed that it was free of glare and visual artifact complaints that plagued as much as 35% of multifocal lens users.

Some studies have also been performed to test long-term stability, and it seems that Synchrony remains an effective vision solution. Vision tests and reading speeds performed at one and two-years postoperatively show that Synchrony recipieints retain visual acuity. Ultrasound biomicroscopyconfirms the continued ability of the lens to accommodate at six months, one year, and two years postoperative. Finally, the three-year capsule opacity rate for Synchrony is very low (1.9% at three years). It has also been confirmed that laser capsulotomy does not interfere with the lens' ability to accommodate.

Synchrony has been approved for use in Europe. Industry experts had hoped it would be approved by the FDA last year, but so far there has been no decision. There is no evidence available to distinguish whether the delay is just due to FDA slowness or if it is due to data that suggests a weakness in the system that we have not seen.

To learn more about this or other advanced vision correction options, please contact an ophthalmologist today.