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Flexivue Microlen® an intracorneal inlay for the treatment of presbyopia

Session Details

Session Title: Refractive 1

Session Date/Time: Friday 03/02/2012 | 08:30-10:00

Paper Time: 08:36

Venue: Hall 1

First Author: : V.Feingold UNITED STATES

Co Author(s): :    I. Pallikaris   M. Fantozzi           

Abstract Details

Purpose:

To reduce or eliminate the use of spectacle dependence in emmetropic presbyopes for near vision and to improve near visual acuity.

Setting:

Multicenter study in the University of Crete, Greece and Prato Hospital, Italy.

Methods:

A prospective randomize study of 40 emmetropic patients who were implanted Flexivue Microlens® (Presbia, The Netherlands) using a femtosecond laser (AMO IFS150) that created a special pocket between 280 to 300 micron depth from the anterior surface of the cornea. The lens implanted in a non-dominant eye of a presbyopic patient. Patients had near visual acuity of J5 or worse. The age group was from age 45 to age 60. Uncorrected distance visual acuity of all patients was between 20/20 to 20/32 before surgery. RESULTS Mean near uncorrected visual acuity before surgery was J10 and after implantation of Flexivue Microlens® for a period of 12 months the visual acuity was improved to J2. The preoperative range was J5 to J14 and 12 months after surgery 75% of patients were in the range of J1 to J2. The average preoperative binocular distance visual acuity was 20/20 and 12 months after surgery the uncorrected binocular visual acuity stayed at 20/20. However, the average uncorrected distance visual acuity for the operated eye was reduced to 20/40 from 20/20. Best corrected distance visual acuity before and after surgery has stayed throughout the follow-up period at 20/20. One lens was reposition due to the fact that it was not placed in the visual axis during the original procedure and one lens was removed due to excessive glare, as the patient did not want to wait until neuro-adaptation may reduce the glare effect. In both cases the outcomes were very satisfactory to the patients. Most patients were spectacle free for near vision.

Conclusions:

12 months of implantation in the cornea of Flexivue Microlens®, using a femtosecond laser to create a pocket, demonstrated that the procedure is safe and effective to improve the near visual acuity from J10 to J2. No major clinical adverse events have been reported for the duration of the study.

Financial Disclosure:

... gains financially from product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... is employed by a for-profit company with an interest in the subject of the presentation, ... has significant investment interest in a company producing, developing or supplying product or procedure presented