Presbyopia Challenge | July/Aug '17

Presenting Corneal Inlays

Many patients seeking LASIK do not know about this presbyopia-correcting option.

The idea for using corneal inlays to modify refraction has been around for almost 70 years. In 1949, Barraquer introduced his idea of keratophakia—shaping donor corneal tissue on a cryolathe, and implanting it in the cornea to alter a patient’s refraction.1 Since that time, there has been a long history of attempts to find biocompatible synthetic materials and implant designs that allow the cornea to maintain its physiologic function and also predictably improve refraction.2-6

After decades of refinement of the concept, a number of corneal inlays have in recent years reached the market, and each has amassed a significant quantity of clinical data demonstrating efficacy and safety. These inlays, rather than addressing myopia or hyperopia as Barraquer and others tried to do, are designed to improve near vision in presbyopic patients. Typically, a corneal inlay is implanted under a flap or in a stromal pocket in only the nondominant eye to boost near vision, leaving distance vision mostly unchanged. In patients who are not emmetropic, a corneal inlay can be combined with LASIK.

Commercially available corneal inlays include:

  • The Kamra inlay (AcuFocus). This inlay, with an opaque ring surrounding a central aperture, operates on the pinhole optical principle, increasing the implanted eye’s depth of focus. Its diameter is 3.8 mm, with a central aperture of 1.6 mm and thickness of 5 µm. The Kamra was the first corneal inlay to receive both the CE Mark and US FDA approval.7
  • The Raindrop Near Vision Inlay (formerly PresbyLens; ReVision Optics). Made of transparent hydrogel, this inlay is 1.5 to 2 mm in diameter, and its thickness ranges from 10 µm at the periphery to 32 µm in the center. Its index of refraction is similar to that of the cornea, and its effect comes from reshaping the center of the cornea.8 The Raindrop has both the CE Mark and FDA approval.9
  • The Flexivue Microlens (Presbia). This hydrophilic acrylic implant is 3.2 mm in diameter and 15 µm thick at its edges. Central thickness varies with power, which ranges from 1.50 to 3.50 D, and there is a central opening 0.51 mm in diameter. It is a refractive implant, with a mechanism of action similar to that of a multifocal IOL. The Flexivue has received the CE Mark in Europe, but it is not approved by the US FDA.10 This past year, Presbia purchased the assets of Neoptics, a company that was developing another refractive corneal implant, the Icolens.11

Common Questions on Corneal Inlays

Question No. 1: What is the difference between vision with An inlay and with monovision?

Drs. Moarefi and Bafna: Monovision is a strategy that is often employed to improve near vision for presbyopic patients such as yourself. Essentially, one eye is corrected for distance, one for near. Sometimes this causes problems for patients such as loss of stereo vision and depth perception. The inlay is different from monovision because you would not lose significant distance vision in the operated eye, which is your nondominant eye. You might lose 1 line of distance vision in that eye, but you would gain 5 or 6 lines of near vision, so it is not a one-to-one tradeoff. Plus you will still have good distance vision in your unoperated eye.

Question No. 2: Will my eye look different or strange with the implant in place?

Drs. Moarefi and Bafna: Raindrop is completely transparent, so it cannot be seen. The Kamra does have a pigmented ring, as you can see in the manufacturer’s picture (Figure 1). You might think that there would be a cosmetic concern, in that the ring would be visible to others. Strangely, though, it is almost impossible to tell that an eye has had an inlay and LASIK. Let me introduce you to our staff member who has a Kamra inlay. Can you tell which of his eyes the inlay is in (Figure 2)?

Figure 1. Specs of the Kamra inlay.

Figure 2. The Kamra inlay in situ.

Question No. 3: Will my vision return as quickly after the inlay as it does after LASIK?

Drs. Moarefi and Bafna: You may have read on the internet or heard from friends that good vision returns almost immediately after LASIK—what people refer to as the wow effect. The inlay is different from LASIK. There is a gradual neural adaptation that takes place while your eyes learn to use the reading add. It is like a journey in which, as every week goes by, vision continues to progressively improve. As long as you realize that the change is not instantaneous, but gradually improves, you will probably adapt well to it.

Question No. 4: Is the implant removable?

Drs. Moarefi and Bafna: In refractive surgery, we make a distinction between subtractive technologies and additive technologies. LASIK is a subtractive technology, meaning that we remove tissue from the cornea and we cannot put it back. An inlay is an additive technology. We put the inlay under a flap in your eye, and, if necessary, we can take it out. At that time, your vision should return to its preoperative level.

Question No. 5: What are the risks?

Drs. Moarefi and Bafna: The risks with an inlay procedure are very low, similar to those of LASIK because we must create the flap or stromal pocket in which we will place the inlay. As I mentioned previously (Question No. 4), if there is a problem with the inlay, we can take it out. In our practice right now, about 98% of patients who receive inlays are very happy with them. We have explanted inlays from less than 2% of patients, which is a very low number. Most patients are accepting of the vision change. And in the few patients who have undergone explanation, all of them have had their vision return to baseline levels.

INTRODUCING THE CONCEPT

Despite a long history and extensive clinical experience, corneal inlays are not widely known among the general public. In our refractive surgical practice, few patients ask specifically for corneal inlays. Therefore, we usually take it upon ourselves to introduce the idea of a presbyopia-correcting inlay when we see patients who we think might benefit from this technology.

In a typical case, for example, a patient may come in expressing interest in a more familiar refractive surgical procedure, such as LASIK, for his or her myopia or hyperopia. (We generally do not see emmetropic presbyopes, who tend to manage well with reading glasses and do not think often of refractive surgery. Patients who seek refractive surgery usually have a fairly significant refractive error that binds them to their glasses or contact lenses all day long.)

When a patient seeking LASIK is of presbyopic age—40 years and above—we point out that LASIK will address only his or her distance vision, meaning that he or she will still have to wear reading glasses after surgery. At this point, we would initiate discussion of ways to remedy that situation, and a corneal inlay would be one of the options.

Clearly, when patients express interest in any type of refractive surgery, this suggests that they are interested in getting rid of their glasses. For presbyopes, then, our discussion with them begins with the question, “Are you interested in reducing your need for spectacles for all ranges of vision postoperatively?”

We always discuss all options for dealing with presbyopia, including bifocal and progressive spectacles in addition to surgical approaches. But, when patients answer that question positively, depending on their refractive error, we may present monovision laser refractive surgery and corneal inlays as options.

Depending on the patient’s age and level of refraction, we may also offer refractive lens exchange with either a multifocal or extended depth of focus IOL. Because we are based in the United States, we note that the two types of inlays that are available to them are the Raindrop and the Kamra. Table 1 shows a comparison of these two inlays and the Flexivue Microlens, available now in Europe.

When a patient expresses interest in one of these corneal inlays, we proceed with our evaluation, making sure the eye and the patient are healthy, determining whether the patient qualifies for surgery, and assessing the patient’s refractive state. Doing this helps us to determine which inlay might be more appropriate.

MAKING A RECOMMENDATION

We usually describe both corneal implants to the patient but make sure to offer a sound recommendation for one or the other. As Barry Schwartz pointed out in The Paradox of Choice,12 having too many choices makes things more complicated for patients—it can paralyze the patient and make moving forward with a decision more challenging. To avoid this, we try to listen to the patient, gauge his or her needs, and make a suggestion with the aim of meeting those needs.

If the patient is slightly hyperopic, we may recommend the Raindrop. Because the hyperprolate shape that the Raindrop produces may theoretically function better in someone with a potentially flatter cornea, the so-called sweet spot for the Raindrop is 0.50 D. For someone with a slight myopic refractive error, we lean toward the Kamra. The sweet spot for this inlay is -0.75 to -1.00 D. We have information on both inlays on our practice website, and we offer patients pamphlets from the manufacturers if they are interested in learning more about the devices. By far the greatest educational resource we have, however, is the six staff members in our practice who have had a Kamra inlay placed in their own eyes. When patients are interested in getting an inlay, we let them talk directly to someone who has had the procedure, so they get a first-hand description of what the experience was like. This personal touch is far more valuable to patients than any website or promotional material that we can provide.

With that said, however, undoubtedly when patients decide on pursuing surgery with a corneal inlay, they will have questions. In the accompanying sidebar, we answer the five most common questions we receive from patients regarding inlay surgery, followed by answers pulled from the first page of hits on a Google search.

1. Barraquer JI. Modification of refraction by means of intracorneal inclusions. Int Ophthalmol Clin. 1966;6(1):53-78.

2. Lane SL, Lindstrom RL, Cameron JD, et al. Polysulfone corneal lenses. J Cataract Refract Surg. 1986;12(1):50-60.

3. Knowles WF. Effect of intralamellar plastic membranes on corneal physiology. Am J Ophthalmol. 1961;51:1146-1156.

4. Dohlman CH, Refojo MF, Rose J. Synthetic polymers in corneal surgery. I. Glycerylmethacrylate. Arch Ophthalmol. 1967;77(2):252-257.

5. Werblin TP, Peiffer RL, Binder PS, McCarey BE, Patel AS. Eight years experience with Permalens intracorneal lenses in nonhuman primates. Refract Corneal Surg.1992;8(1):12-22.

6. McDonald MB, McCarey BE, Storie B, et al. Assessment of the long-term corneal response to hydrogel intrastromal lenses implanted in monkey eyes for up to five years. J Cataract Refract Surg. 1993;19(3):213-222.

7. FDA approves first-of-its-kind corneal implant to improve near vision in certain patients [press release]. US Food and Drug Administration. April 17, 2015. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm443471.htm. Accessed May 30, 2017.

8. Raindrop Near Vision Inlay Professional Use Information. Revision Optics. March 2017. http://www.revisionoptics.com/wp-content/uploads/2016/09/710-0015-Rev-6-Artwork-FDA-Professional-Information-Brochure-US.pdf. Accessed May 30, 2017.

9. ReVision Optics receives FDA approval for the Raindrop Near Vision Inlay [press release]. ReVision Optics. June 29, 2016. http://www.revisionoptics.com/raindrop-near-vision-inlay-fda-approval/. Accessed May 30, 2017.

10. The Presbia Flexivue Microlens. Presbia. https://presbia.com/surgeons/. Accessed May 30, 2017.

11. Presbia acquires comprehensive patent portfolio for the Presbia Flexivue Microlens [press release]. Presbia. August 22, 2016. http://investors.presbia.com/releasedetail.cfm?ReleaseID=985078. Accessed May 30, 2017.

12. Schwartz B. The Paradox of Choice. New York: HarperCollins; 2004.

author
Shamik Bafna, MD
  • Cataract and Refractive Surgeon, Clear Choice Laser Eye Center and Cleveland Eye Clinic, Brecksville, Ohio
  • drbafna@clevelandeyeclinic.com
  • Financial disclosure: Consultant (AcuFocus, Revision Optics), Researcher (Presbia)
author
M. Amir Moarefi, MD
  • Department of Ophthalmology, Case Western Reserve University Hospitals, Cleveland, Ohio
  • amir.moarefimd@gmail.com
  • Financial disclosure: None acknowledged
author
Daniel Chang, MD | Section Editor
  • Private practice at Empire Eye and Laser Center in Bakersfield, California
  • dchang@empireeyeandlaser.com
  • Financial interest: None acknowledged

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