Recently there have been several press releases and advertisements for the FDA-approvals of two brands of corneal inlays: the KAMRA Inlay and the RAINDROP Inlay. Both inlays are small discs that are implanted into the front of the cornea in only one of your eyes; typically, the non-dominant eye. Each are advertised to improve near vision without glasses without impairing distance vision.
The problem with these inlays is that outcomes have not proven to work as advertised – by some estimates they may result in complications or dissatisfaction in up to 20 percent of implanted eyes.
Is it wise it to pay $5,000 for a procedure that may not give satisfaction 20 percent of the time? Let’s explore the two options.
KAMRA works based on a pinhole effect that increases depth of focus. The lens must have a pre-operative refraction of -0.50 diopter of sphere to obtain an ideal outcome. This means that LASIK will need to be performed first and then the inlay second, requiring two separate procedures for the patient.
The goal is to see at both distances – near in one eye and distance in the other eye. Many side effects have been reported including glare, severe halos, and compromised night driving vision. In other cases, reading vision may not prove satisfactory to function without spectacles. Imagine paying $5,000 and still having to wear readers while experiencing glare and halos at night.
Multiple clinics in Europe and Asia have ceased implanting corneal inlays. In some cases, patients must stay on chronic steroid drops to prevent corneal haze and inflammation. I have met with surgeons that tell patients that there is up to a 10 percent chance that the inlay may need to be removed (explanted). I personally know one patient with steroid induced glaucoma and another that had to use steroids every day for months. Additionally, if chronic inflammation occurs, there is a high risk of permanent scarring of the cornea.
RAINDROP is a small inlay disc placed in the central cornea to steepen the central cornea. This steepening improves near vision but slightly drops the clarity of the distance image. Most patients do not see 20/20 at both distance and near. Again, LASIK will likely need to be performed first. The ideal refraction prior to the inlay is just opposite of the KAMRA at + 0.50 to + 0.75 sphere.
The biggest issue with this inlay is chronic and late onset inflammation. I have personally managed one patient with permanent corneal haze after the RAINDROP was explanted. I am close with a surgeon who has managed several cases of the cornea melting on top of the inlay resulting in irreversible scarring and loss of vision.
Across the nation, you will find many trained corneal specialists such as myself that do not believe in corneal inlays. This belief is supported by experience with procedures like INTACS and epikeratophakia, where sudden late onset corneal haze, melts and fibrosis may be encountered.
I published an article critical of corneal inlay technology in “Cataract and Refractive Surgery Today”. Click here to read the article.
Please approach these new technologies with caution. They will likely produce patient satisfaction 80 percent of the time or provide a shorter-term solution, but this still means that the dissatisfaction rate could be as high as 20 percent. Let’s compare this to LASIK, where large multi-center trials show satisfaction above 96 percent.
Loden Vision Centers is committed to providing only procedures that have proven to be the safest and have success rates of 95% or higher so that our patients are getting the very best treatments available.
For more information or to book a consultation to discuss your treatment options, please contact us at 615-859-3937.