One surgeon provides insight into his surgical technique for implantation of corneal inlays.
Uncorrected presbyopia results in avoidable vision impairment, and as of 2005, more than 1 billion people globally were classified as presbyopic.
In the United States, 55% of the population wears vision correction, and of this segment of the population, 53% are prebyopic. The majority of these presbyopes wear spectacles for presbyopia correction.
Freedom from glasses is attractive to a subset of the presbyopic population and can be achieved in many ways. In addition to contact lenses, presbyopia correction may be surgically achieved using monovision LASIK or PRK, conductive keratoplasty, scleral spacing procedures or refractive lens exchange.
IntraCor (Technolas Perfect Vision), a new, non-U.S. Food and Drug Administration-approved procedure, involves the use of a femtosecond laser to reshape the interior of the cornea without any surface penetration. The use of presby-LASIK is another option; however, presby-LASIK is also not currently FDA-approved in the United States.
Yet another novel way to correct presbyopia is through the use of corneal inlays. The two corneal inlays currently undergoing FDA clinical trials are Raindrop (ReVision Optics) and Kamra (AcuFocus).
In this surgical maneuvers column, Minoru Tomita, MD, PhD, describes the surgical technique for, as well as his experience with, the use of corneal inlays to correct presbyopia.
Thomas “TJ” John, MD
OSN Surgical Maneuvers Editor
The Kamra corneal inlay is an effective option for the treatment of presbyopia. The device is made of polyvinylidene fluoride with nano particles of carbon. The ring has a central aperture of 1.6 mm, which increases depth of field and improves near and intermediate vision with minimal impact on distance vision. The inlay is currently available in Japan and approved in 48 other countries, and the final module of the product’s pre-market approval has been submitted to the FDA.
In East Asian countries such as Japan, the majority of the population is myopic. Furthermore, the prevalence of patients with high myopia is higher in Asia than in white, black and Hispanic populations.
In our clinic, more than 1 million patients have already been treated with LASIK surgery to correct their refractive error. To address these myopic and post-LASIK presbyopes, I developed the protocol for implanting the Kamra inlay post-LASIK surgery, either independent of the initial LASIK surgery, or as a planned two-step procedure. I have found that both approaches cause fewer dry eye symptoms and result in higher patient satisfaction than thick-flap procedures.
Post-LASIK Kamra procedures begin with careful patient evaluation. The patient must be evaluated for dry eye disease, and any symptoms should be treated aggressively. It is extremely important that the corneal surface is in good condition at the time of the surgery.
It is also important to perform optical coherence tomography imaging to confirm the original LASIK flap thickness. Surgeons should never rely on the planned or programmed flap thickness from the prior LASIK procedure.
To achieve the best range of vision, the patient’s postoperative refraction in the inlay eye should be −0.75 D. Post-LASIK Kamra patients experience an average myopic shift of −0.60 D, so I prefer for my patients to be between plano and −0.25 D at the time of inlay insertion. Any hyperopic refraction needs to be corrected prior to inlay implantation to ensure optimal outcomes.
Patients who present with both ametropia and presbyopia should receive both the Kamra inlay and LASIK correction. The LASIK procedure is performed as usual with a 100-µm flap (Figure 1). Among these patients, the postoperative refractive target for the non-inlay eye should again be between plano and −0.25 D.
Whether performed separately or as a two-step procedure, the pocket interface must be created at least 100 µm below the original flap interface. In my practice, I create the pocket and insert the inlay a minimum of 1 month after the LASIK procedure. If necessary, an enhancement can be performed at the time of inlay implantation by lifting the original LASIK flap.
Figure 1. Perform a traditional thin-flap LASIK procedure at least 1 month prior to inlay implantation.
Images: Tomita M