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20-20 Vision Perfection
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Keraflex and accelerated crosslinking patient information leaflet 25th March 2011 Version 3
Patient information LeafletKeraflex (Microwave Thermoplasty) for the correction of Keratoconus)
Keraflex® KXL is currently CE marked and licensed for use in Europe for the treatment of keratoconus (KC), a degenerative disorder which causes the cornea to thin and bulge from its natural state to a conical shape resulting in distortion of vision. There are limited therapeutic options currently available for treating KC. Upto 10% will require corneal transplantation. There is no currently established treatment option for high diopter refractive correction among KC patients, other than corneal transplantation and now, keraflex.
On average, the onset of KC begins in the mid teens. The disorder afflicts millions of teens and young adults around the world, severely affecting their visual acuity and often requiring corneal transplants. In the UK, over 30000 people are affected by keratoconus with approximately 500 undergoing corneal transplantation annually. Corneal transplants may take upto 18 months for full visual recovery and approximately 40 percent will require a regraft within 10 years.
Keraflex is a new thermokeratoplasty procedure used for the treatment of keratoconus. The Keraflex procedure uses microwave energy delivered in a small annulus to the corneal mid-periphery. This procedure flattens the cone and helps to regularise the cornea. By combining the procedure with a modified collagen crosslinking procedure there is a marked improvement in the stability of the eye.
Clinical results suggest Keraflex KXL flattens the protruding cone of keratoconus and makes the irregular cornea smoother, thereby improving visual acuity. Adjunctive selective collagen cross linking enhances the induced refractive effect as well as stabilize the keratoconic cornea.
In addition improved visual acuity, Keraflex KXL holds the potential to increase tolerance to contact lens wear and to improve vision correction with glasses among KC patients. Further, this non-invasive procedure will ultimately help keratoconus sufferers, with no alternative therapeutic options, avoid corneal transplants.
During a Keraflex® procedure, the Vedera™ KXS delivers a single low energy microwave pulse lasting less than one second. Energy is applied to the cornea using a dielectrically shielded microwave emitter which contacts the epithelial surface. Through capacitive coupling, the single pulse raises the temperature of the selected region of corneal stroma to approximately 65°C, shrinking the collagen and forming a toroidal lesion in the upper 150 microns of the stroma.
Using an evaporative
ing technique (patent pending), the Vedera KXS
s the surface of the cornea during the treatment to isolate and protect Bowman’s membrane from the thermal effects of the microwave energy.Accelerated Crosslinking
At 20-20 Vision Perfection we are proud to say that we are amongst the world leaders in the treatment options for keratoconus. We have the UK’s first Keraflex treatment and accelerated crosslinker.
Collagen crosslinking has been used for almost a decade to arrest the progression of keratoconus by ‘hardening’ the cornea. Today, over 50000 procedures are performed annually, with our experience growing every year.
We all know that keratoconus is a progressive condition affecting the cornea of the eye. The cornea is the clear window at the front of the eye. It is a curved structure allowing it to act as a lens and focus an image
o the retina. In keratoconus, the cornea loses the normal chemical links between collagen strands, causing the cornea to be unusually elastic. The pressure inside the eye then pushes the cornea into a distorted, conical shape. The cornea moves from being a smooth curvature like a football to a distorted shape, similar to a rugby ball. This distorts the quality of the image projected into the eye, and the vision becomes progressively blurred.
The idea behind crosslinking the cornea is to prevent progression of the keratoconus to a stage that corneal transplantation will be required. Anyone with progressive keratoconus is potentially suitable. Patients with very advanced keratoconus or whose vision is already spoiled by scarring will usually not be good candidates for the procedure.What are the intended benefits of Collagen Crosslinking?
Enhance corneal rigidity
Increase the corneal resistance and biomechanical stability of the cornea
Prevent progression of keratoconus
May defer the need for a corneal transplant procedure
May reduce the nearsightedness and astigmatism associated with keratoconus
Enhance contact lens wear
Reduce risk of progressive keratoconus after laser vision correctionWhat is Accelerated Crosslinking?
Traditionally, Collagen Crosslinking for keratoconus treatment is a painless, out-patient procedure. It is performed under topical anaesthesia. The skin of the eye (epithelium) is removed. Riboflavin eye-drops are applied to the cornea for 30 minutes. The eye is then bathed in a very specific wavelength of light-UVA for 30 minutes. The combination of the light and riboflavin causes chemical
s to form within the cornea, increasing its rigidity and stability.
The whole process traditionally takes about 90 minutes. A protective soft contact lens is worn for about 24 hours, and eye drops need to be instilled to limit the risk of infection and corneal haze.
The accelerated crosslinking mirrors the procedure above bur differs and benefits patients in 2 ways:
1. Reduces cross-linking time from one-hour to a few minutes, adding to patient comfort and experience
2. More importantly, accelerated crosslinking allows thinner corneas to be crosslinked with greater precision, potentially decreasing the risks associated for crosslinking. In effect those patients outside current treatment criteria can be crosslinked and receive the same benefits as below.
The procedure is extremely safe, and no sight-damaging complications have been reported.How is the Keraflex procedure performed?
Keraflex procedure takes in total less than 30 seconds to perform. There is no cutting or blades involved in this procedure. The actual corneal reshaping takes less than a second. The procedure is undertaken under topical anaesthetic, under aseptic techniques. Following the procedure, debris on the surface of the eye is removed and a protective contact lens placed on the surface to help with healing. You will be given antibiotic drops to take and some painkillers for any discomfort.What do you expect after the procedure?
You will very likely have blurred vision until the Keraflex settles down. You may even experience discomfort with lights, see a white ring on the cornea (Keraflex ring), or suffer some discomfort/pain which typically will last 24-48 hours.
After 7-10 days, you will come back to clinic and get rescanned. If there is a significant benefit from the scan then we will recommend cross-linking. However, you will unlikely notice any major benefit in vision at this stage.Accelerated crosslinking after Keraflex.
A brief description of the crosslinking procedure is given above.
Firstly, the cornea is anaesthetised. This is done by placing drops in your eyes. Whilst this is being done, antibiotics are applied to the eyes to fight infection. Once the eye is anaesthetised, a special surgical instrument is used to dislodge the cells on the surface of the cornea. Once these cells have been dislodged, drops of vitamin B2 (Riboflavin) are applied to the eye every few minutes for approximately 10 minutes. Once the surgeon is satisfied that sufficient riboflavin has been absorbed by the cornea, the light treatment can begin. This treatment will last a total of 3 minutes. The riboflavin that was applied earlier on in the procedure will now ensure that the cornea absorbs the UVA light. Once the operation is finished a protective lens will be fitted to the eye and further antibiotics applied. This protective lens will need to be kept in place for 1 – 2 days.
The UVA light that the cornea absorbs during the treatment causes cross-linking. The cross-linking that takes place after the exposure to the light will take place over the few days following the operation. Once the cross-linking has taken place it will then take a little longer for the cornea to begin flattening.What is involved after the operation?
After a few days you will need to return to have the protective contact lens removed. After this your eye care professional will give you eye-drops to be taken for the following few weeks. Following this we simply recommend that you continue to have annual visits to your optometrist as you did before your operation.What are the risks involved with CXL?
As with any operation, there are some risks. During the CXL procedure the surface of the cornea is dislodged. This opens up the possibility of infection. We manage this risk by applying antibiotics both before and after the procedure, but there is always still a small risk. There are also cases where the cornea becomes hazy and may interfere with your vision. This usually settles. Ultimately, with any new innovation, we cannot tell you long-term risks of CXL. However, with 13 years experience we have experienced no long-term adverse effects. In terms of the Keraflex, once the white outline of the ring disappears there maybe only some residual scarring of the cornea. Keraflex uses similar technology as a procedure called Conductive keratoplasty, so we anticipate that the Keraflex will have no long lasting effects other than what is discussed. In fact the reason for crosslinking the cornea after the Keraflex is that we know that the effects of Keraflex will wear off if we don’t.
Can using UV light for cross-linking cause any harm?
The UVA light that is used in this procedure is measured very closely. The light that causes harm in sunlight is UVC. The light that is emitted by the cross linker device is completely harmless.
Before each treatment the UVA light is very carefully measured and checked. The machine itself also performs many safety checks to ensure the patients safety. In the past, there have been concerns that the UVA light may cause damage to the retina. These concerns are no
longer valid as the riboflavin in the cornea absorbs all of the UVA light before it gets to the retina. However, we will not know the long-term risks that may occur in 20-30 or 40 years. Our experience with this procedure is improving and it appears that it is safe.What can you expect after the Keraflex and crosslinking?
It is hoped that Keraflex will reshape the cornea and crosslinking hold the shape. This will allow patients to achieve improved vision ideally without aids, but in certain cases patients will find glasses or soft contact lenses will improve the residual left after Keraflex. Optimum effect occurs over 3 months but most patients begin to see the improvement after 2-3 weeks.
What other options do I have?
This really depends on the degree of keratoconus, compliance with contact lenses and self-motivation. Options include: contact lenses, spectacle correction, INTACS and as a last resort corneal transplantation. We would be happy to discuss these options if you feel that they these would be useful to you.