Presbia Coöperatief U.A. (Amsterdam) introduced its new Flexivue System for implantation of a small corneal inlay to correct presbyopia at the recent 2009 annual meeting of the European Society of Cataract and Refractive Surgeons in Barcelona, Spain.
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:
- Numbing eye drops are applied to the eye to prevent discomfort.
- A femtosecond laser is used to create a small pocket in the center of the cornea.
- 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.