The CE mark certifies that the implantable micro-lens meets European Union consumer safety, health and environmental requirements.

The approval was announced in a press release issued last month by Presbia, the Amsterdam-based ophthalmic device company that makes the Flexivue lens.

“Today’s CE certification of the Flexivue lens validates our technology and will enable us to move forward with commercialization of our solution for the huge presbyopic market by mid-2010,” Presbia’s CEO Zohar Loshitzer said in the press release.

The Flexivue implant is just 3 millimeters in diameter and less than 20 microns thick at its edge and is made of a hydrophilic (“water-loving”) plastic polymer similar to materials used for intraocular lenses used in cataract surgery for the past 20 years, according to Presbia.

The Flexivue lens is implanted in a small pocket in the center of the cornea that is created with a femtosecond laser. The refractive surgeon inserts the lens into the corneal pocket with a proprietary device developed by Presbia.

Once the lens is properly positioned within the cornea, the pocket seals itself to keep the lens in place.

The Flexivue lens can be left in the eye indefinitely, or it can be removed and replaced if the patient’s visual needs change.

The lens is implanted only in the patient’s non-dominant eye, and the entire procedure generally takes less than 10 minutes.

[Ed. note: The Flexivue corneal implant has not yet been evaluated or approved by the U.S. Food and Drug Administration for use by eye surgeons in the United States.]

SOURCE:  Presbia’s Flexivue micro-lens receives European market approval. Press release issued December 3, 2009 by Presbia. (Viewable at presbia.com.)

The Flexivue intracorneal inlay is designed to restore near vision lost to normal age-related changes in the lens inside the eye by increasing the curvature of a small central zone of the clear front surface of the eye.

The added curvature increases magnification to improve near vision and reduce the need for reading glasses in people over age 40 with clear distance vision.

Flexivue corneal inlay design

The tiny and ultra-thin Flexivue corneal inlay is 3 millimeters (mm) in diameter and has an edge thickness of less than 0.02 mm. The clear micro-lens is made of a hydrophilic (water-absorbing) plastic similar to a soft contact lens material.

The device is implanted in the center of the cornea and can stay in place permanently or can be removed and replaced with a stronger corneal implant if greater magnification for reading is needed.

Implantation of the Flexivue inlay creates a variable curvature to the cornea, similar to the curves on certain multifocal contact lenses.

When successfully implanted, the device should provide improved near and intermediate vision with minimal loss of distance clarity.

The corneal implant procedure

The implantation procedure for the Flexivue corneal inlay typically takes less than 10 minutes and, like LASIK and PresbyLASIK, is performed on an outpatient basis.

Usually, the corneal inlay is implanted in the patient’s non-dominant eye to reduce the risk of any decrease in distance vision.

The steps of the procedure are:

1. Numbing eye drops are applied to the eye to prevent discomfort.
2. A femtosecond laser is used to create a small pocket in the center of the cornea.
3. The Flexivue inlay is implanted in the corneal pocket.

The corneal pocket soon seals itself, securing the inlay in proper position in front of the pupil. Due to its small size, the inlay is virtually invisible, even in blue eyes.

Flexivue clinical trials to begin soon

Clinical trials of the Flexivue System will begin prior to the end of the year under the direction of Ioannis Pallikaris, MD, PhD, according to the company.

Dr. Pallikaris, director of the Institute of Vision and Optics at the University of Crete, Greece, leads Presbia’s medical advisory board and will train surgeons to perform the Flexivue System at his clinical facilities.

Note: At the time of this posting, the Flexivue System and Flexivue corneal inlay for the treatment of presbyopia have not received FDA approval for use by refractive surgeons in the United States.

SOURCE:  Presbia unveils implantable micro-lens. Ophthalmology Times. October 2, 2009.