The best treatment for keratoconus will depend on its severity and how quickly it is progressing. Make sure your cross-linking is FDA-approved and covered by insurance. As a treatment for low myopia, Intacs ® corneal implants were a market failure since LASIK provided better, more consistent results with a lower complication rate. The implants also have the advantage of being removable and exchangeable. We then use the Phorcides Analytical Software designed by Mark Lobanoff, MD, to help plan refractive topography-guided correction of the cornea. The front surface called the cornea and it's like a clear window to the eye.. 18 While the “Dresden protocol” with epithelial removal is an established standard, some corneal surgeons are now performing variations of CXL, including trans-epithelial (epi-on) application of riboflavin drops. Corneal cross-linking is a treatment for an eye problem called keratoconus.. Several studies show that Intacs can improve the best spectacle-corrected visual acuity (BSCVA) of a keratoconic eye by an average of two lines on a standard eye chart. SEE ALSO: Answers From An Eye Doctor About Keratoconus >. Because the center of scleral and semi-scleral lenses vaults over the irregularly shaped cornea, these lenses don't apply pressure to the eye's cone-shaped surface for a more comfortable fit. Because of the precise nature of the back surface fit, high quality and individualized optics can be placed on the front surface of the device. The first is the Corneal Cross Linking procedure, also known as CXL. You optician will be able to advise on what’s best for you. Your eye care practitioner will monitor closely the fitting of "piggyback" contact lenses to make sure enough oxygen reaches the surface of your eye, which can be a problem when two lenses are worn on the same eye. In the mildest form of keratoconus, eyeglasses or soft contact lenses may help. Keratoconus. Keratoconus usually affects both eyes and generally begins to first affect people ages 10 to 25. These larger lenses also are more stable than conventional gas permeable contact lenses, which move with each blink because they cover only a portion of the cornea. These are large-diameter gas permeable contacts — large enough that the periphery and edge of the lens rest on the "white" of the eye (sclera). Click here to find a cornea specialist near you. While more study is needed, early results of a small study involving topography-guided conductive keratoplasty (CK) show this procedure might help smooth irregularities in the corneal surface. The aim of this procedure is to strengthen an already weak cornea by ‘cross linking’ the collagen fibres found in the cornea. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. enews. Comparison of sequential vs same-day simultaneous collagen cross-linking and topography-guided PRK for treatment of keratoconus. Keratoconus Treatment. The maximum keratometry reading decreased from 54.61 D to 43.48 D, and corneal cylinder decreased from 7.46 D to 3.18 D. It is an exciting time to be managing patients with keratoconus in the United States. IVMED 80 eye drops for treatment of keratoconus in patients -Phase 1/2a. Researchers have found that epithelial thickness is fairly uniform from the center to the periphery in healthy corneas. Photrexa Viscous® (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) are used with the KXL®System in corneal cross-linking to treat eyes in which the cornea, the clear dome shaped surface that covers the front of the eye, has been weakened from the progression of the disease keratoconus or following refractive surgery, a method for correcting or improving your vision. Figure 2. At A Glance. When considering cataract surgery in patients with keratoconus, there may be certain factors to take into account before developing a surgical plan.Experts discussed treatment options for these patients, steps to take before surgery, how they decide on a plan of action, and appropriate lens options. Keratoconus treatment can include eyeglasses, special hard con Keratoconus diagnosis include a comprehensive eye exam and tests to determine your corneal shape. To decrease patient discomfort and mitigate risks, epi-on CXL protocols that leave the epithelium intact while still adequately strengthening the cornea are of interest. While keratoconus can be a challenging condition, it can be managed effectively when detected early. The UltraHealth and ClearKone hybrid contact lenses manufactured by SynergEyes combine a highly oxygen-permeable rigid center with a soft peripheral "skirt." Keratoconus (ker-uh-toe-KOH-nus) occurs when your cornea — the clear, dome-shaped front surface of your eye — thins and gradually bulges outward into a cone shape.A cone-shaped cornea causes blurred vision and may cause sensitivity to light and glare. Brian Boxer Wachler, MD, is an ophthalmologist and refractive surgeon at the Boxer Wachler Vision Institute in Beverly Hills, Calif. Also, progressive mild to moderate keratoconus has been safely and successfully treated with a combination of corneal crosslinking and implantation of a toric phakic IOL. Cleveland Clinic is a non-profit academic medical center. With the sequential approach, CXL is followed 1 to 2 years later by topography-guided PRK (TG-PRK). Nattis A, Donnenfeld ED, Rosenberg E, Perry HD. With this strategy, known as epi-off CXL, come patient discomfort and the risks of delayed epithelial healing, infection, sterile infiltrates, and stromal haze. More by this author . Preoperative BCVA was 20/80. In a first-ever collaboration, 4 supranational cornea societies joined forces in a complex, multistep process to develop the Global Consensus on Keratoconus and Ectatic Diseases. Update on Keratoconus Treatment. Tissue engineering is the science of improving or replacing biological tissue using various growth factors. What’s the difference between an HSA and FSA? Keratoconus is a progressive eye condition that affects the cornea, causing it to bulge out. 10. A New Zealand team of researchers has developed a tissue-engineering approach to treating keratoconus. This system uses proprietary Elevation Specific Technology to exactly match the unique irregularities of each individual eye. Keratoconus affects men and women equally, about 1 in 500 to 2,000 individuals overall, and 5-15% of individuals born with Down Syndrome. Keratoconus is a progressive eye disease in which the normally round cornea thins and begins to bulge into a cone-like shape. 7. For the detection of early keratoconus, Placido disc–based topography has been supplanted by Scheimpflug tomography, which can map both the anterior and posterior corneal surfaces. Ophthalmologists have long believed that they should never perform PRK or LASIK on an eye with ectasia because of the risk of worsening the condition. Keratoconus is actually a disease of the surface of the eye. Keratoconus Treatment. Corneal crosslinking may reduce significantly the need for corneal transplants among keratoconus patients. Advantages include less risk of infection, less discomfort and one-day visual recovery. The popularity of and evidence for corneal biomechanical measurements for detecting glaucoma risk are growing. At our clinic, we have been developing a Minneapolis epi-off protocol. 72. Get useful, helpful and relevant health + wellness information. Go to www.livingwithkeratoconus.com/ to obtain the FDA-approved product labeling. 6. Keratoconus - Causes, Symptoms and Treatment August 20, 2019 Keratoconus is an eye condition, where the cornea which is usually round and dome-shaped begins to … It's the only keratoconus treatment proven to slow or stop the progression of the disease. With epithelium-off crosslinking, the outer layer of the cornea (called the epithelium) is removed to allow entry of riboflavin, a type of B vitamin, into the cornea, which then is activated with UV light. This technology allows the laser system to identify and target raised topographic features, such as an elevated cone, thereby normalizing the shape of an irregular keratoconic cornea to improve BCVA. Read more. 4. Treatments for progressive keratoconus include: This procedure, also called corneal collagen cross-linking or CXL, strengthens corneal tissue to halt bulging of the eye's surface in keratoconus. Corneal crosslinking. Vinciguerra R, Ambrósio R, Roberts C, Azzolini C, Vinciguerra P. Biomechanical characterization of subclinical keratoconus without topographic or tomographic abnormalities. Tomographic and biomechanical Scheimpflug imaging for keratoconus characterization: a validation of current indices. [65] [66] The Save Sight Keratoconus Registry is an international database of keratoconus patients which is tracking outcomes of cross-linking in patients with keratoconus. Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-A-induced collagen crosslinking for the treatment of keratoconus. Click here to view your insurance policy. Investigators have found that posterior corneal changes are an early marker for ectasia, preceding changes on the anterior surface. For progressive keratoconus, only Avedro's corneal cross-linking procedure is FDA approved and widely covered by insurance. Subclinical keratoconus detection by pattern analysis of corneal and epithelial thickness maps with optical coherence tomography. Available Treatment Options. Comparison of standard and accelerated corneal cross-linking for the treatment of keratoconus: a meta-analysis Acta Ophthalmol . For keratoconus, this method involves placing a soft contact lens, such as one made of silicone hydrogel, over the eye and then fitting a GP lens over the soft lens. 2. In 2016, however, the FDA approved cross-linking surgery as a treatment for keratoconus and recommended that a registry system should be set-up to evaluate the long-term treatment effect. With the simultaneous approach, TG-PRK is followed immediately by CXL. 2020;61:2587. August 9, 2019 | By First Eye Care DFW. These measurements can also provide valuable information on a patient’s risk of ectasia. Keratoconus is a non-inflammatory eye condition in which the normally round dome-shaped clear window of the eye (cornea) progressively thins causing a cone-like bulge to develop. The use of any drug or drugs other than Photrexa Viscous and Photrexa or any device other than the KXL System for corneal cross-linking is not FDA approved, except as part of an investigational new drug study. Keratoconus Diagnosis and Treatment - American Academy of Ophthalmology Keratoconus diagnosis include a comprehensive eye exam and tests to determine your corneal shape. Tear fluid analysis for detecting biomarkers for keratoconus and targeted treatments such as Cyclosporine A to reduce MMP-9 and inflammatory cytokine levels are being researched to decrease progression. With the epithelium-on method (also called transepithelial crosslinking), the corneal epithelium is left intact during the treatment. The idea is to maximize the CXL effect in the weakest region of the cornea, usually inferiorly, and to apply weaker amounts of irradiation in concentric rings expanding out from the cone. What happens to FSA dollars at the end of the year? The surgical procedure takes only about 10 minutes. In this case, eye drops containing low levels … You can expect frequent return visits to your eye care provider so he or she can fine-tune the fit and your prescription, especially if your keratoconus continues to progress. By contrast, in an ectatic cornea, the epithelial layer exhibits significant thinning over the cone (Figure 1), sometimes surrounded by a “doughnut” of thicker epithelium.¹ This epithelial masking effect on the anterior surface may explain in part why it is easier to detect early ectasia on the posterior surface. Currently, the only corneal cross-linking platform that is FDA-approved for the treatment of progressive keratoconus in the U.S. is epithelium-off cross-linking performed with a Glaukos KXL System and proprietary Photrexa and Photrexa Viscous riboflavin solutions. Some people with keratoconus can't tolerate a rigid contact lens, or they reach the point where contact lenses or other therapies no longer provide acceptable vision. Research is driving promising advances in diagnosis and treatment. Doctors then send the resulting impression to an EyePrint lab for 3-D scanning. You are encouraged to report all side effects to the FDA. Optovue was the first manufacturer whose OCT technology gained FDA approval for epithelial thickness mapping. We perform accelerated CXL with pulsed 18 mW UV-A delivery and allow oxygen to reenter the cornea between UV-A treatments (2 minutes on, 1 minute off, 1 minute on, 1 minute off, 2 minutes on). Custom toric soft contacts for keratoconus are significantly more expensive than regular soft contacts, but vision insurance may cover some of the costs associated with contact lenses for keratoconus. The original Dresden CXL protocol is time-intensive, requiring 30 minutes for riboflavin instillation followed by continuous application of UV-A radiance at 3 mW/cm² for 30 minutes, for a total treatment time of 1 hour.6 Theoretically, the UV-A intensity can be increased and illumination time proportionally decreased, resulting in the same photochemical effect. This approach increases wearer comfort because the soft lens acts like a cushioning pad under the rigid GP lens. 11. 1. UltraHealth and ClearKone are available in a wide variety of parameters to provide a fit that conforms well to the irregular shape of a keratoconic eye. Intacs might delay but can't prevent a corneal transplant if keratoconus continues to progress. Your doctor should monitor defects in the outermost corneal layer of the eye for resolution. As the cornea becomes more irregular in shape, it causes progressive nearsightedness and irregular astigmatism to develop, creating additional problems with distorted and blurred vision. All RIghts Reserved • Privacy Policy. Medicaid: Eligibility and Vision Benefits. Share: Link has been copied to your clipboard. 9. New technologies are improving our ability to diagnose keratoconus earlier than ever before and facilitating visual recovery with remarkable results. Meanwhile, the National Keratoconus Foundation reports a link between allergies and keratoconus. Accelerated corneal collagen cross-linking in thin keratoconic corneas. A recent addition to the analysis of corneal curvature involves mapping the thickness of the corneal epithelium with OCT. Accessed 8/27/2019. Two devices are available in the United States to measure corneal biomechanics: the Corvis ST (Oculus Optikgeräte) and the Ocular Response Analyzer (Reichert). The EyePrintPRO can only be fit by doctors who undergo specific training and certification. However, most modern contacts — both GP and soft — typically have adequate oxygen permeability for a safe "piggyback" fit. Kanellopoulos A. Figure 1. Several studies have supported this concept of accelerated protocols and have shown similar results in arresting keratoconic progression with illumination times ranging from 3 to 10 minutes.7,8 This approach is becoming more popular with corneal surgeons around the country because it is more convenient for patients and for the surgical team. Recent research has shown that this approach can shorten epithelial healing times because of the smaller abrasion zone needed and also strengthen the flattening effect.11. Other ocular side effects include inflammation, An important step in standard CXL is removing the epithelium in order to maximize riboflavin penetration and oxygen availability, both of which are critical to the CXL photochemical reaction. The market for keratoconus treatment was around USD 322.7 million in 2016 and is expected to reach USD 427.5 million by 2023 which is a projected CAGR of 4.1%. 8. Get useful, helpful and relevant health + wellness information. Corneal crosslinking without epithelial removal. The risk information provided here is not comprehensive. It's a non-invasive procedure that strengthens the cornea by "cross-linking" the cornea's collagen fibres through the application of Riboflavin drops and exposure to UV-A light. Invest Ophthalmol Vis Sci. Example of epithelial mapping of a keratoconic cornea. This article highlights promising recent advances in keratoconus management. We do not endorse non-Cleveland Clinic products or services. The traditional method is called “penetrating keratoplasty” (PK). Mark Lobanoff, MD. To treat keratoconus there are two corneal transplant methods. All About Vision and AllAboutVision.com are registered trademarks of AAV Media, LLC. Steinberg J, Siebert M, Katz T, et al. Fitting contact lenses on an eye with keratoconus often is challenging and time-consuming. Because fitting a gas permeable contact lens over a cone-shaped cornea can sometimes be uncomfortable for a person with keratoconus, some eye care practitioners advocate "piggybacking" two different types of contact lenses on the same eye. The process begins with an EyePrint Impression, which captures the precise curvatures of the entire ocular surface. A topographic "map" created by computer imaging of the eye's surface helps create individualized treatment plans. Ozgurhan E, Akcay B, Kurt T, Yildirim Y, Demirok A. Contact lenses or glasses can be used to help correct vision, while FDA-approved corneal cross-linking is a non-invasive treatment to slow or halt keratoconus that is progressive. Riboflavin 5’ … The most common ocular side effect is haze. 13. Toker E, Çerman E, Özcan DÖ, Seferoglu ÖB. Recently, contact lens manufacturers have introduced custom soft contact lenses specially designed to correct mild-to-moderate keratoconus. IVMED-80, a twice-daily eye drop for the treatment of keratoconus in development by iVeena Delivery Systems, was recently granted orphan drug designation by the FDA. Advertising on our site helps support our mission. Molokhia S, Muddana SK, Hauritz H, et al. View PDF. These lenses were designed specifically for keratoconus, and the central GP zone of the lens vaults over the cone-shaped cornea for increased comfort. Retinal detachment: Symptoms, causes and treatment. Postoperative UCVA was 20/25. Glare and light sensitivity also may occur. 73. Studies have shown that both devices can differentiate normal from keratoconic corneas; the Corvis is able to do so in the absence of topographic or tomographic data.2-4 Further studies are being done to validate the recently developed Tomography and Biomechanical Index, which is a value combining Scheimpflug tomographic and biomechanical data for enhanced detection of ectasia.5. This imbalance makes the cornea more susceptible to oxidative damage from compounds called free radicals, causing it to weaken and bulge forward. Intacs may be needed when keratoconus patients no longer can obtain functional vision with contact lenses or eyeglasses. Intacs (Addition Technology) are FDA-approved clear, arc-shaped corneal inserts that are surgically positioned within the peripheral cornea to reshape the front surface of the eye for clearer vision. Eyeglass temples: How do you know if they're the right length? In this condition, the front part of your eye, called the cornea, thins out and gets weaker over time. New technologies and regulatory approvals have made the diagnosis and treatment of keratoconus an exciting field for ophthalmologists and optometrists alike. © 2000-2020 AAV Media, LLC. In March, Carl Zeiss Meditec gained FDA approval for epithelial thickness mapping with its Cirrus HD-OCT. Explore further Genetic factors behind eye disorder identified 5. It also is being investigated as a way to treat or prevent complications following LASIK or other vision correction surgery. Risk factors for oxidative damage and weakening of the cornea include a genetic predisposition, explaining why keratoconus often affects more than one member of the same family. We do not endorse non-Cleveland Clinic products or services. Are contact lenses a good choice for kids? 1. Hybrid contact lenses provide the crisp optics of a gas permeable contact lens and wearing comfort that rivals that of soft lenses, according to SynergEyes. In 2016, Avedro's corneal cross-linking procedure became the first and only FDA approved corneal cross-linking treatment for progressive keratoconus. In 2003, WaveLight developed technology to perform topography-guided excimer laser treatment. Accessed 8/27/2019. The FDA approval of corneal cross-linking (CXL) has ignited further research into how best to halt ectatic vision loss and how to recover visual acuity through combined procedures. As keratoconus advances, the corneal surface becomes increasingly irregular and these options do not help adequately. Join our community to receive newsletters and offers. Cleveland Clinic is a non-profit academic medical center. OCT epithelial mapping can provide supplemental information that should improve early detection of subclinical keratoconus. Today, the treatment is widely covered by commercial insurance. fine white lines, dry eye, disruption of surface cells, eye pain, light sensitivity, reduced sharpness of vision, and blurred vision. But as the disease progresses and the cornea thins and becomes increasingly more irregular in shape, glasses and regular soft contact lens designs no longer provide adequate vision correction. How older drivers can improve their driving at night, Improve your driving at night: With tips on glasses and lenses. To learn more, talk to your healthcare provider. The only FDA-approved medication to treat the progression of keratoconus is riboflavin 5´-phosphate ophthalmic solution. Because simultaneous treatments were found to produce the best results, we use the following regimen. Stulting RD, Trattler WB, Woolfson JM, Rubinfield RS. Often, keratoconic patients experience changes in their eyeglass prescription every time they visit their eye doctor. Tell your healthcare provider if you are pregnant or plan to become pregnant. To decrease patient discomfort and mitigate these risks, researchers and clinicians are interested in a CXL protocol that leaves the epithelium intact while still adequately strengthening the cornea. Keratoconus: A Roadmap to Treatment [October 8, 2019 Webinar] Please enjoy this recording of our webinar: “Keratoconus: A Roadmap to Treatment” This webinar was led by our moderator, Dr. Jason Marsack, who discussed with Dr. Maria Walker and Dr. Matt Kauffman from the University of Houston, College of Optometry, where they shared their insight to what the newly diagnosed KC patient can … Keratoconus KC is a condition of the eye which results in liberal thinning of the cornea. Both lenses have a very wide range of fitting parameters for a customized fit and are larger in diameter than regular soft lenses for greater stability on a keratoconic eye. This eventually impairs the ability of the eye to focus properly, potentially causing poor vision. There are two versions of corneal crosslinking: epithelium-off and epithelium-on. Keratoconus Treatment Options. More by this author . IVMED-80, a copper-based eye drop is also being researched for its effect on increasing lysyl oxidase activity and corneal stiffness. As research advances, gold-standard technologies gradually change. "The EyePrint is like a fingerprint—it's completely individual," says EyePrint developer Dr. Christine Sindt, Clinical Associate Professor of Ophthalmology and Visual Sciences at University of Iowa. enews. Although the procedure halted keratoconic progression, it did not improve patients’ VA. Treatment options for keratoconus In the early stages of keratoconus, corrective glasses or contact lenses can help the patient. (Glaukos recently acquired Avedro.). The original protocol for performing CXL focused solely on strengthening the cornea by forming bonds between corneal fibers. As one would expect, the cohort in which both topographic and refractive error was treated had better UCVA and BCVA outcomes than the cohort limited to the treatment of topographic abnormalities.13. OCT epithelial mapping will not replace corneal tomography, but it can provide supplemental information that should improve early detection of subclinical keratoconus. A potential solution, therefore, would be to combine laser ablation with a strengthening procedure such as CXL. Research suggests the weakening of the corneal tissue that leads to keratoconus may be due to an imbalance of enzymes within the cornea. This cone shape deflects light as it enters the eye on its way to the light-sensitive retina, causing distorted vision. Intacs ®, intrastromal corneal ring segments, were approved for keratoconus treatment in 2004.Previously, Intacs ® segments were used to treat low amounts of myopia (under -3.00). In this surgery, the ophthalmologist removes full-thickness central cornea and replaces it with donor tissue, known as a “corneal button.” Supported by the National Keratoconus Foundation, this safe, minimally invasive outpatient procedure works by stiffening the weakened cornea to slow or halt progression of the disease. The risk for keratoconus is increased in people who have asthma (as reported by the American Optometric Association).More than 23 million people in the US are living with asthma, and the onset of this health disorder often begins in childhood. Corneal crosslinking is a modern corneal scar treatment that can slow the progress of keratoconus. This leads to a strengthening of the structure of the cornea. This treatment uses energy from radio waves, applied with a small probe at several points in the periphery of the cornea to reshape the eye's front surface. The Avedro KXL system is indicated for treatment of progressive keratoconus in patients ages 14 and older by first debriding the corneal epithelium. These medium-water hydrogel lenses can correct up to 30 D of nearsightedness or farsightedness and up to -10 D of astigmatism. Visual and keratometric outcomes of keratoconus patients after sequential corneal crosslinking and topography-guided surface ablation: Early United States experience. . 12. Eyes with advanced keratoconus may require an advanced prosthetic scleral lens design. In the United States, custom soft contacts that are available for the correction of keratoconus include: KeraSoft lenses (Bausch + Lomb). Since then, the procedure has been completed more than 18,000 times at more than 300 practices nationwide. As access, insurance coverage, and use of these technologies improve, visual disability from keratoconus will be a rare occurrence in the near future. Keratoconus also is associated with overexposure to ultraviolet rays from the sun, excessive eye rubbing, a history of poorly fitted contact lenses and chronic eye irritation. Even after a transplant, you most likely will need glasses or contact lenses for clear vision. Gore DM, Leucci MT, Anand V, et al. 2019 Feb;97(1):e22-e35. Vinciguerra R, Ambrósio R, Elsheikh A, Roberts C, Lopes B, Morenghi E, Azzolini C, Vinciguerra P. Detection of keratoconus with a new biomechanical index. A. John Kanellopoulos, MD, developed the Athens protocol and has investigated the safety and efficacy of both sequential and simultaneous treatments. This is a non-invasive treatment for patients with keratoconus. Download PDF. Both technologies facilitate the identification of biomechanically at-risk corneas before any decompensation begins to alter corneal curvature. Research is driving promising advances in diagnosis and treatment. The last remedy to be considered may be a cornea transplant, also called a penetrating keratoplasty (PK or PKP). Dr. Kanellopoulos found that both methods were safe when the ablation depth was limited to 50 µm, with no patients showing disease progression, but he reported that the simultaneous method resulted in better final visual acuity results.12, Earlier this year, Nattis and colleagues published a study in which TG-PRK was used not only to normalize topography but also to treat refractive error beyond the 50-µm threshold.13 In the study, patients underwent CXL followed by TG-PRK 30 months later on average.