INTACS - KERAVISION INTACS
About Intacs:
Corneal Ring Segments
FdA Approved Correction Of Mild Myopia
Non-Laser Procedure
Immediate Vision Correction
Superb Optics, Excellent Visual Results
Maintenance Free Correction
Central Cornea Undisturbed, No Tissue Removal
Great Flexibility - Removable, Replaceable
Potential For Reversibility
Biocompatible Material With 50 Years History In Eyes
Permanent Tiny Corneal Inserts
Office Procedure With Drop Anesthesia
GENERAL QUESTIONS ABOUT INTACST
Q. What are IntacsT?
A. Intacs corneal ring segments are the revolutionary way to correct mild nearsightedness-without laser surgery. They provide an alternative to eyeglasses, contact lenses, and surgical procedures that permanently alter the eye by cutting or removing tissue from the central cornea.
Intacs are two tiny half rings. To get an idea of how small they are, just imagine a contact lens where the center part has been removed and only the very outer edge remains; then imagine this ring divided into two equal halves. That's how tiny Intacs are. They are made of a special biocompatible plastic that has been safely used in contact lenses and cataract surgery for nearly 50 years. When placed in the periphery of the cornea, they are practically invisible-and they cannot be felt. Intacs reshape corneal curvature without removing tissue from the central optical zone, the area of the cornea that is most critical for clear vision. This subtle reshaping makes nearsighted corneas flatter, thereby correcting vision.
Intacs are the result of nearly a decade of clinical research and have been available in other countries for several years.
Q. What are the advantages of IntacsT?
A. Intacs offer several key advantages:
- Intacs are a safe and effective means to correcting mild nearsightedness.
- Intacs are FDA-approved.
- Intacs offer an immediate improvement in vision.
- Intacs provide excellent results. In U.S. clinical studies, 97% of patients saw 20/40 or better with Intacs, 74% saw 20/20 or better, and 53% saw 20/16 or better.
- Intacs are maintenance-free.
- Tissue is not removed from the central optical zone, the region of the cornea most important for clear vision.
- Intacs offer greater flexibility, because they can be removed or replaced.
Q. Who is a candidate for IntacsT?
A. Intacs are currently available for people with mild myopia (nearsightedness) who have no more than 1.00 diopter of astigmatism. The best way to find out if you are a candidate for the procedure is to schedule an appointment with Your Doctor so he can evaluate your vision.
You may qualify for Intacs, if:
- Your prescription for eyeglasses or contacts is between -1.00 and -3.00 diopters, with no more than 1.00 diopter of astigmatism. If you don't know your current prescription, we can schedule you for a complimentary examination and consultation;
- You have healthy eyes, free from disease or injuries;
- You have had stable vision for at least one year; and
- You are at least 21 years of age.
Q. Who is not a candidate for IntacsT?
A. You should not have Intacs placed if:
- You have autoimmune or immunodeficiency diseases (lupus, rheumatoid arthritis or AIDS, for example);
- You are pregnant or nursing;
- You have known conditions of the eye that may increase the possibility of future problems; or
- You are taking prescription medications that may affect corneal healing or your vision.
- Your Doctor will review your general medical history with you and will evaluate your eyes for any conditions that might suggest you should not have Intacs. It is important to advise Your Doctor if you have had a Herpes infection in your eyes or if you have insulin-dependent diabetes or other medical condition that might affect wound healing. You should also bring a list of any prescription and over-the-counter medicines that you take.
Q. What are IntacsT made of?
A. Intacs are made of a special biocompatible plastic that has been safely used for nearly 50 years in contact lenses and in the intraocular lenses used to treat patients with cataracts. Intacs are designed for permanent placement in the eye, but they are also removable.
Q. What is the difference between IntacsT and other refractive procedures?
A. Intacs are designed to be placed in the outer edge of the cornea away from the "central optical zone." Because nearly all the light that reaches the retina must pass through the central optical zone, it is the part of your cornea most important for clear vision. Therefore, it is essential not to damage the central optical zone. The procedure for placement of Intacs does not cut or remove tissue from the central optical zone. This makes the procedure quite different from other refractive surgical procedures that permanently alter the central cornea. Intacs are also removable and replaceable.
Q. How do IntacsT work?
A. Simply, Intacs gently change the shape of your cornea to correct your vision. In the nearsighted eye, the curve of the cornea is too steep. Light rays entering the eye are bent too much and are focused in front of the retina-instead of on it. As a result, things far away appear blurry. Intacs change the shape of the cornea, allowing the light rays to focus on the retina. But unlike laser surgery, which reshapes the cornea by removing tissue from the center, Intacs are placed in the outer edge-leaving the central optical zone intact.
Q. What is the central optical zone and why is it so important?
A. The central optical zone refers to the center area of your cornea. Virtually all light that enters your eye passes through the central optical zone in order to be focused. For this reason, the central optical zone is crucial to clear vision. Intacs corneal ring segments are specially designed to be placed in the outer edge of the cornea away from the central optical zone. - back to top
GENERAL QUESTIONS ABOUT THE PROCEDURE AND AFTERWARD
Q. What's involved in the procedure?
A. Typically, patients are given a mild oral sedative and eye drops to numb the eye before the procedure. A tiny opening, less than 2 mm, is made near the upper edge of the cornea beneath the upper eyelid. Intacs are inserted through this opening so that they rest between the layers of tissue in the cornea, outside the central optical zone. This procedure usually takes about 15 minutes and is performed in our office.
Q. What are the risks?
A. As with any refractive surgical procedure, there are certain risks and complications. Your Doctor will be happy to discuss the potential risks and benefits in detail with you. Clinical studies in the U.S. showed that infection, which is a risk with any surgical procedure, occurred 0.2% of the time following the placement of Intacs. Other adverse events included: shallow Intacs placement (0.2%, temporary loss of 2 lines of best-corrected vision (0.2%) and anterior chamber perforation during surgery (0.4%). None of these events resulted in a permanent loss of vision. Other complications included: over correction, reduction in central corneal sensation, difficulty with night vision, under correction, induced astigmatism, blurry vision, double vision, corneal blood vessels, halos, glare, fluctuating distance vision and a reduction of 2 or more lines of best corrected vision. If the results of the procedure are not satisfactory, your Intacs may be removed or replaced.
Q. How long does it take to recuperate?
A. The majority of patients notice significantly improved vision the first day after surgery. Most people resume normal activities usually the next day.
Q. Who does the procedure, and where is it performed?
A. Your Doctor, who has received special training in the placement of Intacs, will perform the procedure. The procedure will be performed in our office operating room.
Q. How long does the procedure take?
A. The procedure takes approximately 15 minutes for one eye, and you go home the same day. The total procedure, including the pre-surgical preparation, is usually completed in less than one hour.
Q. Will both eyes be done on the same day?
A. Both eyes may be corrected - the decision will be made by you and Your Doctor.
Q. What can I expect my vision to be?
A. In U.S. clinical studies, 97% of patients saw 20/40 or better with Intacs; 74% saw 20/20 or better-the standard for good vision, and 53% saw 20/16 or better-a level that exceeds the standard for good vision.
| Uncorrected Vision | Day 1 | Month 3 | Month 12 |
| 20/16 | 13% | 49% | 53% |
| 20/20 | 34% | 71% | 74% |
| 20/25 | 55% | 86% | 87% |
| 20/40 | 81% | 97% | 97% |
Q. Will I still need glasses or contact lenses after the procedure?
A. Typically, patients no longer depend on glasses for correction of their distance vision. Some patients may still wear glasses for reasons specific to their situation. For example, Intacs does not correct presbyopia (the difficulty with near vision), so you may need reading glasses. It is not recommended that a contact lens be worn on an eye that has Intacs.
Q. How long do Intacs T stay in the eye?
A. Intacs are intended to remain permanently in place without maintenance, yet as an Intacs trained ophthalmic surgeon, Your Doctor can easily remove them.
Q. Can IntacsT be felt once they are in place?
A. No. Intacs are not felt because they are placed in the cornea beneath the nerve endings.
Q. Can IntacsT be seen by the naked eye?
A. Intacs are rarely noticeable to other people and their appearance in the eye is similar to a contact lens. They might be seen up close with a flashlight shining on your eye from the side.
Q. Can they dry out or get dirty like a contact lens?
A. No. Intacs are designed to remain permanently in place within the cornea and don't require maintenance.
Q. Could I have an allergic reaction to Intacs?
A.cataract operations and outside the eye for contact lenses. It has not been known to interact with eye tissue to produce an allergic reaction or other side effects, such as swelling or irritation.
Q. What if my vision changes?
A. As you get older, your eyesight will change. If the Intacs you were given no longer provide the amount of correction you need, they may be removed or replaced. If they are replaced, your recovery is as rapid as the original procedure. If you choose to proceed to another procedure such as LASIK, that procedure can usually be performed within a month. If the Intacs are removed with no other procedure planned, your vision will return to its original level almost immediately but will continue to improve over three month's time. Your Doctor will help you determine the best means to accommodate any changes in your vision.
Q. What will my vision be like if I later want Intacs removed?
A. Intacs can be easily removed in a brief outpatient procedure. When Intacs were removed in U.S. clinical studies, patients' vision returned to their preoperative levels in most cases. This process typically took up to three months. All patients' corrected vision was 20/20 or better following the removal of Intacs. back to top
QUESTIONS ABOUT COST AND MORE INFORMATION
Q. What will this procedure cost?
A. The fee for Intacs and the procedure to insert them is typically similar to other refractive procedures for vision correction, such as LASIK. The fee is as low as $100 per month.
Q. How can I get more information?
A. The best way to see if Intacs are right for you is to schedule an appointment for a brief complimentary evaluation. If you would like further information, you can also call the manufacturer's toll-free information line, 888-8INTACS (888-846-8227) or visit the web site, "www.getintacs.com".
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