Policyholder Services



Does my OMIC policy extend coverage for implanting corneal inlays?

Updated 10/2/2019

Yes.  Under the Surgery Class 3 rating classification, coverage automatically extends to refractive surgery procedures, including implantation of corneal inlays.  Physicians who perform such procedures must be appropriately trained and certified as required by the manufacturer.

The KAMRA Inlay is a small, ring-shaped device that is implanted in the cornea to improve near vision. The FDA granted approval in April 2015 for this device for a very narrow range of indications. It is approved for intrastromal corneal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 who have a cycloplegic refractive spherical equivalent of +0.50 D to -0.75 D with less than or equal to 0.75 D of refractive cylinder, who cannot focus clearly on near objects or small print without glasses, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 D to +2.50 D of reading add.

In late June 2016, the Raindrop Near Vision Inlay became the second FDA-approved implantable corneal device for correction of near vision. As with the KAMRA Inlay, the Raindrop Inlay was approved for a narrow range of indication. It is approved for intrastromal corneal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 65 who have a manifest refractive spherical equivalent of +1.00 D to -0.50 D with less than or equal to 0.75 D of refractive cylinder, who cannot focus clearly on near objects or small print without glasses, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.50 D to +2.50 D of reading add. According to the ReVision Optics web site, the Raindrop Inlay will no longer be sold to ophthalmic practices or distributors as of January 30, 2018.

Although the safety and effectiveness of corneal inlays in patients who have had LASIK or other refractive procedures is unknown, OMIC will extend coverage for the off-label treatment of patients who have previously undergone refractive surgery, provided such patients meet the FDA’s age and visual requirements noted in the product’s FDA-approved label. Patients should sufficiently recover from the original refractive surgery procedure and their vision should stabilize before undergoing the inlay procedure.  We recommend that refractive surgery not be performed in conjunction with implantation of the inlay.  OMIC will also cover the off-label treatment of pseudophakic patients who meet the visual requirements established by the FDA.  Discuss any off-label use with the patient and appropriately document this discussion in the patient’s medical record and consent form.

OMIC has developed a sample consent form for on-label use of the KAMRA inlay.  Although many of the risks are similar to those of laser vision correction procedures, some are unique to the inlay. Of particular note, the KAMRA inlay may cause or worsen dry eye syndrome and other vision problems, including loss of depth perception, loss of contrast sensitivity, and glare/halos and night vision problems. The inlay may also cause corneal complications such as corneal edema, clouding, and thinning. Patients experiencing such problems or who are otherwise unhappy with their results may need to have the inlay removed.  However, the patient’s vision may not return to the way it was prior to placement of the inlay.  Decreased vision could be permanent.

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