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    Inlays provide option for presbyopic correction

    Three devices—each based on a different principle—all appear to provide similar results

    Reviewed by Julian D. Stevens, DO

    Almost seven decades after José Ignacio Barraquer, MD, first proposed the idea of a corneal inlay, three devices have come into clinical use for presbyopia correction.

    All three inlays are placed in the non-dominant eye as a monocular procedure. Reviewing their mechanisms, characteristics, and outcomes, Julian D. Stevens, DO, noted that while each is based on a different principle, the three inlays seem to produce fairly similar results.

    “It is interesting that there is no congruence of opinion about design as we have three entirely different methods of dealing with presbyopia with these inlays,” said Dr. Stevens, consultant ophthalmic surgeon, Moorfields Eye Hospital, London.

    Reflecting on the long road to developing successful corneal inlays and looking ahead, Dr. Stevens quoted Winston Churchill: “Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”


















    Pinhole effect

    One inlay (Kamra, AcuFocus) has both the CE mark and FDA approval and is an annular, small-aperture optic that uses a pinhole effect to increase depth of focus. Made of polyvinylidene difluoride, the inlay measures 3.8 mm in diameter and has a 1.6-mm central opening. A series of 8,400 microholes, each 5 to 11μm in diameter, scattered throughout the material allow continued transmission of vital nutrients across the cornea.

    The inlay is placed using a dedicated device into a femtosecond laser-created pocket made at a depth of 200 to 250μm.

    The U.S. IDE study enrolled 507 patients at 24 sites. Eligible patients had a spherical equivalent (SE) ranging from +0.5 to -0.75 D and best-corrected visual acuity of 20/20 or better.

    The analysis of the primary effectiveness endpoint showed that 83.5% of eyes achieved 20/40 or better uncorrected near visual acuity (UCNVA), surpassing the FDA requirement for 75% of eyes to reach that level of vision. Subgroup analyses, however, showed how small differences in refraction significantly affect outcomes, Dr. Stevens said.

    Among patients with emmetropia (SE 0 to +0.25 D), 81.3% achieved 20/40 or better UCNVA in the treated eye. Among participants with very low hyperopia (+0.25 to +0.50 D), only 76.2% achieved 20/40 or better UCNVA, whereas 92% of patients with low myopia could read 20/40 or better without correction.

    “So, the pinhole effect needs a little bit of help to be most effective,” Dr. Stevens said.

    Reading glasses

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