“I think it is best to offer patients only the FDA-approved cross-linking procedure because it was proven safe and effective through rigorous clinical trials, it can slow or halt the progression of keratoconus, and it is well covered by insurance.” – Dr. Barry Lee, Eye Consultants of Atlanta

After being diagnosed with progressive keratoconus, it’s likely that your physician will offer various treatment options, including corneal cross-linking to halt progression of the condition and specialty contact lenses to improve vision. However, many people are unaware that some cross-linking procedures that are offered may not be FDA-approved and are instead considered experimental. It is important to know that iLink is the only cross-linking procedure that has been approved by the FDA (since April 2016) and is the only cross-linking treatment eligible for insurance reimbursement.

iLink is proven safe and effective by the FDA in slowing or halting the progression of keratoconus to help preserve patients’ vision. It works by creating new collagen cross-links and leads to the stiffening of the cornea. Any other corneal cross-linking procedures being offered are unapproved, this means that NOT ALL corneal cross-linking treatments are the same. A doctor may offer corneal cross-linking, but that does not necessarily mean that it is iLink FDA-approved cross-linking. In fact, unlike iLink, unapproved drugs and devices have not been validated by an independent, third party and their manufacturing process has not been evaluated.

Unapproved Cross-Linking Regrets

If someone is treated with an unapproved cross-linking procedure, the FDA has not determined that the drug and devices used are safe and effective. In this case, they risk their keratoconus continuing to progress and needing to be re-treated with cross-linking again or even worse – corneal transplant surgery. Dr. Barry Lee, of Eye Consultants of Atlanta, has seen this firsthand.

One of Dr. Lee’s recent keratoconus patients received unapproved epi-on cross-linking in 2017. The procedure seemed to have ‘worked’ at first; however, the 28-year-old man’s vision is continuing to decline. Now, he will never regain the vision he lost and he faces multiple surgical procedures, long recovery periods, and complex long-term management – something that may not have happened had he received iLink initially. While Dr. Lee believes that one eye has progressed to the point that the patient is no longer a candidate for cross-linking, he is planning to retreat the other eye with epi-off iLink FDA-approved cross-linking to slow or halt the progression[1]. He hopes this will improve the ability to fit the patient for a scleral lens to improve his vision, although a corneal transplant may still be needed in the future.

Dr. Lee feels that the patient wasn’t properly informed of his available treatment options or what he could expect following the unapproved procedure. He believes that it is the responsibility of the referring optometrist and the surgeon who is performing the unapproved cross-linking procedure to inform patients that there was also an FDA-approved procedure available – even if the FDA-approved treatment is not being offered in their practice. In addition, because the man underwent an unapproved procedure, he paid thousands of dollars out of pocket when FDA-approved iLink is widely covered by insurance. Sadly, the patient thought the procedure would allow him to avoid a corneal transplant, but that’s exactly what he will likely need now.

In a recent article featured in Cataract & Refractive Surgery Today, Dr. Lee discusses his experience retreating the patient who received an unapproved epi-on cross-linking procedure. To learn more about this keratoconus and cross-linking story, you can read the full article here.

 

Find a Cross-Linking Expert Near You

Search the directory to locate a cross-linking expert who is familiar with treating progressive keratoconus with FDA-approved iLink.

The results described on this site are based on data collected regarding short- and intermediate-term efficacy of treatment. Individual results are not guaranteed and may vary. iLink may cause haze, inflammation, fine white lines, dry eye, disruption of surface cells, eye pain, light sensitivity, reduced sharpness of vision, and blurred vision. Also, Ulcerative keratitis, a potentially serious eye infection, can occur. Discuss the risks with your doctor and determine if iLink may be right for you.

 

[1] Tzamalis A, Diafas A, Vinciguerra R, Ziakas N, Kymionis G. Repeated Corneal Cross-linking (CXL) in Keratoconus Progression After Primary Treatment: Updated Perspectives. Semin Ophthalmol. 2021 Oct 3;36(7):523-530.

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