Long-term outcomes favorable for bifocal corneal inlay

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Results from 2 years of follow-up demonstrate the efficacy of a bifocal corneal inlay (Flexivue Microlens, Presbia) for correcting presbyopia in emmmetropic patients.

Preoperatively, the spherical aberrations (either central or peripheral) are positive.

Postoperatively, the central spherical aberration Z40 is negative, whereas the peripheral is still positive (Z60). These results are responsible for the increase in the depth of focus and therefore the improvement of presbyopia. (Figures courtesy of Gustavo E. Tamayo, MD)

San Francisco-Results from long-term follow-up support the use of a bifocal corneal inlay (Flexivue Microlens, Presbia) for presbyopia correction in emmetropic patients.

The outcomes were reported by Gustavo E. Tamayo, MD at the annual meeting of the American Society of Cataract and Refractive Surgery. He is director, Bogota Laser Refractive Institute, Bogota, Colombia.

Dr. Tamayo

The inlay measures 3.2 mm in diameter and has an edge thickness of only 15 µm. Featuring a peripheral refractive zone and a central neutral zone, the lens is placed in the nondominant eye using a proprietary insertion tool into a femtosecond laser-created pocket at 300 µm stromal depth.

Outcomes for a series of 12 patients followed for a mean of 23 months (range, 18 to 36) were reported. The patients had a mean age of 52 years (range, 47 to 59). Preoperatively, all eyes with the implant had near uncorrected visual acuity (UCVA) 20/400 or worse and distance UCVA and best-corrected visual acuity (BCVA) of 20/20 or better.

UCVA stability

Stability of near UCVA was achieved by 4 months, and at last follow-up, monocular near UCVA was 20/60 or better in all eyes, 20/40 or better in 10 eyes (83%) and 20/30 or better in 9 (75%).

The procedure resulted in loss of distance UCVA in all eyes with the implant, with the mean decreasing to 20/60 initially. However, the eyes with the implant began to recover distance UCVA at 4 months, and at last follow-up, distance UCVA was 20/40 or better in 10 of the eyes with the implant (83%), and unchanged binocularly from the preoperative level of 20/20. Consistent with the UCVA outcomes, 10 patients (83%) reported spectacle independence while the other 2 patients indicated they were glasses occasionally.

“This inlay offers an excellent alternative to correct presbyopia in emmetropic patients and it has benefits of being noninvasive and easily reversible,” Dr. Tamayo said.

“However, as the outcomes in this study show, the procedure induces monovision,” Dr. Tamayo continued. “The monovision is small, well-controlled, and easily tolerated. Nevertheless, patient selection is critical for obtaining good results.”

Safety data showed patients experienced an initial loss of binocular contrast sensitivity, but it also recovered to baseline and remained stable from 6 months onward. BCVA was unchanged in 10 (93%) eyes with the implant while the other 2 had a 2-line loss.

“No patients suffered incapacitating visual symptoms,” Dr. Tamayo said. “Mild haloes were reported by 5 patients, and 2 patients are not driving at night, but the haloes are decreasing with time.”

Other results from a satisfaction questionnaire showed 100% of the patients were at least “happy” with the correction, of which two-thirds described themselves as “very happy.” In addition, all of the patients were willing to have a second procedure as needed.

“Importantly, no patient has wanted the inlay removed, even those who had loss of BCVA,” Dr. Tamayo said.

Gustavo E. Tamayo, MD

E: gtvotmy@telecorp.net

Dr. Tamayo is a member of the Presbia medical advisory board.

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