LASIK combined with inlays can optimize presbyopia outcomes

Issue: September 25, 2017

A corneal inlay can help improve near vision without disrupting distance vision in patients with presbyopia. Surgeons have had this option for more than 2 years since the FDA approval of the AcuFocus Kamra inlay in April 2015 and the ReVision Optics Raindrop near vision inlay in June 2016.

Ocular Surgery News spoke with refractive surgeons on the tactic of combining LASIK and corneal inlay surgeries to improve outcomes and expand the patient pool eligible for the procedure.

Daniel S. Durrie, MD: Patients are interested in an option that can improve their near vision, is not monovision and does not disrupt their distance vision any more than possible. That is where the inlay category really comes in. My experience has been with the Kamra inlay; I did clinical trials on that, and it is my “go-to.” There are a few reasons why patients like this better than other options. We know from clinical trials and from experience since approval that the effect has a tendency to get better over time and to last a long time. Our patients who are 2 years out from surgery see better than they did 1 year after surgery, and clinical trial evidence shows the effect lasting up to 5 or 6 years.

Patients who do the best with the Kamra inlay are nearsighted in that eye, somewhere between –0.75 D and –1 D, and have a tendency to have good distance vision. Those patients do not come drifting into your office all the time. Most of them are people you have created with LASIK in the past or you do laser surgery in combination. My go-to procedure right now for someone who is a candidate, who wants to have this procedure and meets all the qualifications, is to do laser surgery at the same time. That has become the procedure. Patients only have to have one surgery, and they have a tendency to do the best at near and distance.

R. Luke Rebenitsch, MD: Corneal inlays have been a useful option for patients in our practice. I joined a practice 2 years ago that had previously been 100% laser vision correction (LVC). When I joined, my partner and I immediately decided to add the treatment of presbyopia to our practice given the changing demographics. As such, we added the Kamra and Raindrop inlays as well as refractive lens exchange (RLE). Before the advent of corneal inlays and advanced technology IOLs for RLE, we had been limited to LVC for distance alone or blended/monovision when treating patients in the first stage of dysfunctional lens syndrome. This worked well for many people, but others struggled to adjust. Having inlays available has provided a useful bridge for patients in the early years of presbyopia until they progressed to the later stages of dysfunctional lens syndrome. They have also brought many people in the door who better qualified for other procedures, thereby growing our practice.

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Of note, corneal inlays have a refractive range that works best for each type available in the U.S. As a result, to provide the best visual outcomes, we combine laser vision correction with inlays in most of our patients to increase satisfaction and widen the eligible pool. Without combined LVC, we would have only a fraction of the happy inlay patients that we now have successfully treated.

As of today, presbyopia is now approximately 40% of our practice and the fastest growing segment. Without corneal inlays and combined LVC, the growth of this segment would likely never have achieved the levels that I am seeing in our practice and across the country.

Sondra Black, OD: Presbyopia is regarded by a large number of patients as a disability. For the patient population between 45 and 60 years old with a clear lens and no significant refractive error, corneal inlays are the procedure of choice for us in our practice. Inlays are not as invasive as a lenticular procedure, and patients are much more comfortable with a corneal procedure. The safety feature of inlays being removable adds to that comfort level.

It is rare to encounter a patient with the ideal prescription range for an inlay. For example, we have realized that with the Kamra corneal inlay, the ideal patient is plano in the dominant eye and on average –0.75 D in the nondominant eye. Being able to increase that pool of patients by doing LASIK to achieve the ideal pre-inlay target is crucial in order to achieve good results and have happy patients. There are also millions of post-refractive surgery patients who have become presbyopic and are upset that they now need to wear glasses. Having the ability to insert an inlay in these post-LASIK patients, in a pocket deeper than the existing flap, is our procedure of choice. I am one of these patients, and I have had a Kamra inlay for more than 4 years now and am completely glasses-free.

Jeff Machat, MD, FRCSC, DABO: My introduction to corneal inlays started with my own eye. I turned 50 and became significantly presbyopic, which led me to seek a solution that was reversible, had a high safety profile and was not monovision. I am now binocularly balanced and have distance, intermediate and near vision. I have had the inlay for more than 5 years, and it has been resistant to the progression of presbyopia. I have been extremely pleased. I have performed about 450 corneal inlay procedures over the past 5 years, and overwhelmingly patients are happy with the option.

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There is hand-holding. The ocular surface must be pristine in terms of tear film stability, and there is a slow recovery. In this day of LASIK and instantaneous miracle vision recovery, that has been the biggest difficulty.

I would say that 80% of the patients who are looking for the corneal inlay also require LASIK. Frankly, it has worked out extremely well for us as a practice builder. It does not take any more time in my schedule than just doing a regular LASIK procedure.

We know what to tell patients, and we have learned lots of lessons:

Optimize the tear film in advance; it should be pristine.
Obtaining the correct refraction target is critical.
Patients who are hyperopic in both eyes need both eyes treated; otherwise, every time they try to read their distance eye will try to accommodate because it is their dominant eye, and that throws off the reading eye.
If you want to have happy patients with great results, you need to perform LASIK and hit that target refraction for any corneal inlay. – by Robert Linnehan

References:
FDA approves first-of-its-kind corneal implant to improve near vision in certain patients. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm443471.htm. Published April 17, 2015. Accessed on Aug. 21, 2017.
FDA approves implantable device that changes the shape of the cornea to correct near vision. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm509315.htm. Published June 29, 2016. Accessed on Aug. 21, 2017.

For more information:
Sondra Black, OD, can be reached at Crystal Clear Vision, 33 Hazelton Ave., Toronto, Ontario M5R 2E3, Canada; email: sondra.black@crystalclearvision.com.
Daniel S. Durrie, MD, can be reached at Durrie Vision, 5520 College Blvd., Leawood, KS 66211; email: ddurrie@durrievision.com.
Jeff Machat, MD, FRCSC, DABO, can be reached at Crystal Clear Vision, 33 Hazelton Ave., Toronto, Ontario M5R 2E3, Canada; email: jeff.machat@crystalclearvision.com.
R. Luke Rebenitsch, MD, can be reached at ClearSight Center, 7101 Northwest Expressway Suite 335, Oklahoma City, OK 73132; email: lrebenitsch@gmail.com.

Disclosures: Black reports she is a consultant for AcuFocus. Durrie reports he is a consultant and clinical investigator for AcuFocus. Machat reports he is a consultant and on the medical advisory board for AcuFocus. Rebenitsch reports he receives honoraria from AcuFocus.