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    Inlay’s long-term data speaks to leap forward in presbyopia

    Take-Home Message

    Long-term trial data for a small-aperture corneal inlay (Kamra, AcuFocus) for presbyopia turned in superb results.

    Dr. Vukich

    Madison, WI—A small-aperture corneal inlay (Kamra, AcuFocus) for presbyopia turned in superb results when long-term data were analyzed.

    Monocular uncorrected near visual acuity (UNVA) improved by an average 3.4 lines, intermediate visual acuity improved slightly, and distance visual acuity was unchanged—all of which is very encouraging for patients with presbyopia.

    John Allan Vukich, MD, presented 3-year data from the prospective non-randomized U.S. clinical trial with the inlay that included 507 patients who were naturally occurring presbyopic emmetropes (age range, 45 to 60 years). Refractive errors in this patient population were low levels of myopia and hyperopia (–0.75 and 0.5 D) with no more than 0.5 D of astigmatism.

    All patients had UNVA worse than 20/40 and better than 20/100. Best-corrected distance visual acuity was 20/20 or better bilaterally.

    Implantation of the corneal inlay—a monocular procedure that is performed in the non-dominant eye—is performed during an intralamellar dissection that resembles a pocket into which the device is positioned over the pupil.

    Eyes with the inlay had an average gain in monocular UNVA of 3.4 lines preoperatively to 36 months after implantation, noted Dr. Vukich, surgical director, Davis Duehr Dean Center for Refractive Surgery, Madison, WI.

    36-month follow-up period

    “Importantly, this gain in vision was a sustained improvement that was maintained over the 36-month follow-up period,” Dr. Vukich said.

    All study eyes completed the 36-month follow-up examination.

    An important consideration in patients with presbyopia is the status of intermediate vision. In the study eyes, monocular uncorrected intermediate visual acuity (UIVA) improved, but as expected not to the same extent as near vision. The mean UIVA was 20/25.

    “It is important that there was no loss of intermediate vision during the follow-up period,” he said.

    In addition, monocular uncorrected distance visual acuity was maintained over the course of the study in the eyes with the inlay.

    “The average distance visual acuity remained better than 20/20,” Dr. Vukich said.

    Excellent uncorrected distance binocular visual acuity also was maintained at an average of 20/16 over the duration of the study.

    Long-term results showed that UNVA improved from a mean of J8 to J2 in the eyes with the inlay from preoperatively to 1 month postoperatively and was maintained to 5 years after surgery. The vision in the eye with the inlay and in both eyes was unaffected by the progression of presbyopia, Dr. Vukich noted.

    Normal progression of presbyopia would be expected as a result of lessening of the accommodative ability. Patients continue to do well, however, despite the natural presbyopic progression.

    “This indicates that the vision is unaffected by the continuing presbyopic changes,” Dr. Vukich said. “This is certainly encouraging.”

    John Allan Vukich, MD

    E: [email protected]

    Dr. Vukich is a consultant to and chairman of the medical advisory board of AcuFocus. The device is investigational and not available commercially in the United States.

     

     

     

     

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