The Presbia FlexivueMicrolens™
The Presbia Microlens™, made from a hydrophilic acrylic material, is a permanent yet reversible refractive corneal implant to treat presbyopia. The tiny implant (3.2mm in diameter and 0.015mm/15µ in edge thickness) is barely discernable once placed in the corneal stroma. The lens design is similar to a bi-focal, so light passed to the retina is focused and increase near vision quality without the undesirable effects of Monovision. The Presbia Microlens™ is offered in a wide range of powers ranging from +1.5 diopter to +3.5 diopter, in 0.25 diopter increments.
Implanted in the non-dominant eye, the Presbia Flexivue Microlens™ offers patients functional near, intermediate and distant vision with only a limited reduction in distance acuity in the operative eye.When utilizing binocular vision this reduction in distance acuity is barely noticed by the patient and 99% of patients have 20/20 binocular vision.
The short procedure requires topical anesthesia. With a proprietary inserter, The Presbia Flexivue Microlens™ is placed in a pocket created in the stroma by a femtosecond laser. The pocket self-seals holding the lens in place at the center of the patient’s visual axis.
One of the main advantages of the Presbia Flexivue Microlens™ is that it will not hinder examination of the retina and other structures in the eye necessary to diagnose ocular health disorders.
The peripheral zone of the Presbia Flexivue Microlens™ contains the refractive power to refract light from near objects onto the retina while the central zone has no power and allows light from distant objects to focus onto the retina. The central hole in the lens allows for nutrient flow.
Clinical Data
The 12-month multicenter, Post–Market Ex-U.S. Evaluation demonstrated successful patient outcomes and a low rate of post-operative adverse events.
Average post-treatment UCVA-near vision of 20/27- No significant change in binocular UCVA- distant vision
12-Month Results In Studies Outside The Us
Our lens generally demonstrated positive results in a 2012 post-market evaluation study, 70 emmetropic patients between the ages of 45 and 60 in Italy and Greece were implanted with the Presbia Flexivue Microlens™ using a femtosecond laser pocket.
Over a period of 12 months, the average uncorrected near visual acuity of the patient’s operated eye improved from 20/110 pre-operatively to 20/27 after surgery. In addition, the study also showed that patients experienced no significant change in their distance visual acuity using both eyes, although the distance vision in the operated eye did show declines of about two lines on the Snellen chart. All patients recorded a binocular distance vision of 20/25 or better within one-month of the surgery.
Patient Satisfaction
Drs. Pallikaris and Fantozzi reported that during the 12-month time period after implantation, none of their patients experienced any degradation to the optical system and no major adverse events were reported with the Presbia Flexivue Microlens™.
In addition, patients in this study reported very high satisfaction rates one year after implantation with 97 percent of patients reporting that uncorrected near vision in the implanted eye was either good or excellent, and 97 percent of patients reporting that their uncorrected binocular distance visual acuity was either good or excellent.