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Intrastromal implant improves near vision

Patient satisfaction with outcomes, spectacle independence rates are high at 1 year

Dr. Pallikaris
Crete, Greece—Results from 1 year of follow-up in patients receiving a novel intrastromal implant (Flexivue Microlens, Presbia Coperatief U.A.) show that it safely and effectively improves near vision in patients with emmetropic presbyopia without compromising binocular distance acuity, said Ioannis G. Pallikaris, MD, PhD.

The implant is a doughnut-shaped, bifocal lens with a peripheral refractive zone (+1.25 to +3 D) and a central neutral zone that is implanted in the nondominant eye. Dr. Pallikaris, professor of ophthalmology, University of Crete, and director, Institute of Vision and Optics, Heraklion, Greece, presented outcomes from 12 months of follow-up for a series of 15 patients (mean age 51 years) who had the lens placed inside a corneal tunnel created using a femtosecond laser.

Rapid improvement

Figure 1 The implant is made of a hydrophilic polymer, measures 20 m in thickness with a diameter of 3 mm, and is implanted at a depth of 280 to 300 m. The lens itself is invisible, Ioannis G. Pallikaris, MD, PhD, noted, and so there are no cosmetic issues or interference with a fundus or slit-lamp exam.
The data showed all patients achieved rapid improvement in near vision with no change in binocular distance uncorrected visual acuity (UCVA). Near UCVA increased from 20/50 preoperatively to 20/32 at 1 week, reached 20/30 at 1 month, and was stable at 20/25 from 3 months onward. Distance UCVA in the operated eye decreased from 20/20 preoperatively to 20/40 at 1 week, but returned to ~20/30 at 3 months where it remained unchanged. Distance best spectacle-corrected visual acuity did not change and binocular distance UCVA was 20/20 preoperatively and unchanged after surgery.

Consistent with the UCVA data, patient responses demonstrated excellent visual function. One hundred percent of patients gave ratings of excellent or good to questions about perceptions of their uncorrected near vision, distance vision in the operated eye, and binocular uncorrected distance vision. With a single exception, no patient used spectacles for reading, and the remaining patient reported wearing glasses for near activities less than 50% of the time.

"In addition to these very positive results, implantation of this novel lens has many advantages as a treatment for presbyopia," Dr. Pallikaris said. "The procedure is simple, minimally invasive, and takes only minutes to complete. Unlike LASIK, there are no flap-related concerns, and the device can be replaced or easily removed without adverse effects.

"In addition, the lens itself is invisible, and so there are no cosmetic issues or interference with fundus or slit-lamp exam," he said.

The implant is made of a hydrophilic polymer, measures 20 m in thickness with a diameter of 3 mm, and is implanted at a depth of 280 to 300 m.

"Due to the depth of the implantation, the procedure has a minimal effect on topography," Dr. Pallikaris said.

For the study Dr. Pallikaris presented, tunnel creation for lens implantation was performed using the proprietary femtosecond laser and software (iFS femtosecond laser with the iFlap or iPockets software, Abbott Medical Optics) and a special mask, although other femtosecond lasers can be used.

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