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Welcome to another edition of CEDARS/ASPENS Debates. CEDARS/ASPENS is a joint society of cornea, cataract and refractive surgery specialists, here to discuss some of the latest hot topics in ophthalmology.
Earlier this year, the FDA approved corneal collagen cross-linking for the treatment of keratoconus and corneal ectasia. In this issue, I will discuss how this may affect the way we approach keratoconus patients in the future. I hope you enjoy the discussion.
Current disease courseKenneth A. Beckman
Keratoconus is a progressive degenerative disease of the cornea that typically presents in the teens or 20s and often leads to the need for corneal transplantation. It is estimated that the prevalence is about one in 2,000 patients. For years, eye care professionals were forced to watch helplessly as the disease progressed and patients were inevitably subjected to the need for surgery. While corneal transplant surgery is highly successful for these patients, it is still a major procedure with significant risks and a lifetime of maintenance. Because this disease may present at an early age, it is common for a patient to eventually need a second transplant years later. Also, because so many of these patients are young and active, they are forced to limit their activities at a time in their lives when many of their peers are at their most active. They are particularly vulnerable to trauma and frequently are participating in activities that subject them to trauma.
We all have seen patients run this course. They may present initially in the late teens with a mild cone, but still correctable to 20/20. A few years later, they may still be correctable to 20/25, but they feel they see better in contact lenses. Now they are 26 years old, only correct to 20/40 in glasses and are dependent on rigid gas permeable contacts. All we could do was watch as the vision deteriorated. Soon, they are 30 years old and only correct to 20/200 in glasses. They may still correct to 20/30 in contacts, but they have trouble keeping the contacts on all day. Finally, when they are 32 years old, with a visual acuity of 20/400 in glasses and 20/50 in contacts (assuming that they can even tolerate contacts anymore), they are sent to the corneal specialist for keratoplasty.
This sad scenario is what we all had to endure. While other procedures, such as intrastromal corneal ring segments, may have been developed to help patients cope and temporarily keep their vision at a useful level, they did not stop progression.
Earlier treatment
Fortunately, in the spring, corneal collagen cross-linking was approved by the FDA for the treatment of keratoconus. This remarkable procedure has been the standard of care internationally for years but had not been available in the U.S. other than as part of clinical trials. Corneal cross-linking involves treating the cornea with riboflavin and then exposing the cornea to ultraviolet light to create the formation of collagen cross-links within the cornea. These bonds lead to stiffening and stabilizing of the cornea.
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The primary goal of corneal cross-linking is to stop progression. In addition, cross-linking has been shown to actually lead to flattening of the cornea in many cases. Ideally, a patient should be evaluated for cross-linking immediately after diagnosis. The procedure is at its best when the patient is treated while the vision is still good, to prevent progression. Unfortunately, this is counterintuitive to the classical teaching for the gatekeepers, optometrists and comprehensive ophthalmologists. There is still a tendency for the primary eye care professional to say that the patient is doing well with contacts and does not need any intervention. But is this in the best interest of the patient?
While cross-linking is not without some risk, such as infection and corneal haze, it may be eliminating the eventual need for a far more risky procedure, a corneal transplant. We do not wait until visual field loss advances to treat glaucoma, as the vision loss is irreversible. Similarly, while keratoconus patients may obtain significant improvement with cross-linking, if the cone progresses too far, they may not be able to recover the visual potential they once had if they were treated at an earlier stage. I have related this to many parents of young patients with early cones. If a parent of a young man knew that all of the men in their family had heart attacks in their 40s, they would not wait until their son turned 40 to have him checked. Their genetics tells us that they are extremely likely to have heart disease at a young age. They likely would be evaluated at a much younger age and treated in any way they could to decrease the risk of the inevitable. Well, we know that the 18-year-old cone has a high likelihood of progressing to keratoplasty, so why would we sit on this? Even if those patients would not eventually progress to keratoplasty, many of them still develop significant corneal changes requiring complex contact lenses and less than optimal vision in glasses and contacts.
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This is where we need to completely reverse our approach to this condition. It is no longer fair to the patient to merely stand back and watch as their vision deteriorates. We need to educate the optometrists and ophthalmologists who see these patients. It is critical that these patients are evaluated as early after diagnosis as possible. For many patients, transplantation is inevitable and yet avoidable. In addition, because some patients who are no longer progressing have been shown to actually regress and flatten with treatment, those patients should also be evaluated, as they may also benefit from cross-linking. Eventually, years from now, we will hopefully have a generation of keratoconus patients who were treated in their 20s and by their 40s and 50s are still enjoying excellent vision without needing a transplant. The key is early diagnosis and treatment.
For more information:
Kenneth A. Beckman, MD, FACS, can be reached at Comprehensive Eye Care of Central Ohio, 450 Alkyre Run Drive, No. 100, Westerville, OH 43209; email: kenbeckman22@aol.com.
Disclosure: Beckman reports he was a principal investigator on two FDA clinical trials by Avedro. He currently performs the cross-linking procedure but has no financial interest in the company.
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