Last updated: Jul 1, 2005
Technology is always advancing. At this time, there may be new options for people with Aniridia to get an iris implant device. I write this to share my experience and knowledge in the hopes that others can benefit from it. I will update this document as any new information becomes available.
In early 2004, I first found out about a fairly new procedure that is being used to help people with Aniridia. It is a device which is inserted into the eye and mimics the function of the iris and pupil combination. The main goal of the device is to reduce glare and provide for smoother contrast in vision.
I know of two manufacturers of what is called an Iris Ring. They are Opthec and Morcher. The Morcher device is only available in black while the Opthec offers colors. The color of the device is the color which the patients eye will be, similar to a normal eye.
At least one of these devices was developed overseas and have been used there for a few years (best as I can figure). They are currently under study by the U.S. FDA for possible use in this country. It apparently takes several years of studies to prove to the FDA that the devices are safe. The main factor here is that Aniridia is not all that common and therefore they don't have a wide range of test data yet.
Studies done both here and overseas are showing very positive results so far though. I read two articles that indicate every patient had a positve result, with only one patient having any reaction to the implant (body rejecting the implant) and it was a treatable event.
The device itself consists of one or more pieces which replace the iris and pupil. I have no clue how the device mimics the function of the human iris and pupil, but it is said to provide for similar services and appearance as the real thing. If any parts of the patients iris or pupil is usable, only what needs to be replaced will be implanted. There are many sizes and shapes these devices come in and they can be custom made for any particular situation. These can be mounted to the usable part of the iris.
If there is no usable iris, a tension ring is used to mount the device to the casing of the eye. In this situation, the size of the device would be the full size. The tension ring is just a circular piece which has small mounting arms on it. The surgeon will first inplant the tension ring and suture it to the eye casing. Then, the device is attached to the tension ring.
The actual surgery will be of the outpatient type, which means there is no hospital stay. The surgery is performed at either a hospital or other surgical facility and the patient is released afterwards. A family member or friend must be with to transport the patient to and from the clinic.
If the patient also has a cataract (with many Aniridics do) the surgeon may also deal with that condition at the same time. Cataract removal by hand surgery involves locating the portion of the lens that is clouded and cutting away this part. Laser surgery to remove cataract has the laser beam break up the clouded part. Whichever process is used, there is a portion of the lens which is now missing (or not functioning). More modern cataract surgery has the original lens completely destroyed and an artificial lens used. See the section about cataract surgery for more information on this.
The implant surgery is incision surgery, which means the eye is actually cut into. This is the only way to install internal devices into the eye. A small incision is made to the side of the eye and the device(s) are slid through this. The size of the incision depends on the size of the implant. The device is then slipped through the incision and guided into its proper placement. The device can be turned for postition while it is being inserted. Sutures are used to attach the device and/or the tension ring to the eye. When the work is completed, the insicion is closed.
Since there is punctures made to the eye, there may be some bleeding. The fluids within the eye are constantly being recirculated naturally, which will help to remove the blood or other impurities introduced as result of incision surgery. It may take a day or two for the vision to be clear again.
If the eye can return to its normal operation and does not reject the newly implanted device(s), the surgery is considered to be a success. There is always a chance for infections or rejection of the device.
Either local or regional anesthetic is used during this surgery. The goal is to cease all eye movement during surgery and to halt any pain sensation. Tools are used to hold the eyelids as wide open as possible as well as hold the eye in place. According to what I read, there is feeling of pressure and movement but not pain. Apparently the patient is able to watch the operation as it occurs because there is no way to turn off sight.
The early studies which I have read indicate that the implant rejection levels are very low. There seems to be more of a chance that infections occur as the eye tries to adapt to this new thing inside of it. These infections seem to be rare and also pretty treatable. I have only read about one case of rejection in over 40 cases of documented attempts.
The patient may be required to wear an eye shield during sleep for a period of time after surgery. This prevents reflex rubbing or touching of the eyes. The patient will use eye drops for a few weeks after surgery also. These are usually to stop infections but may include pain relief or moisturizers. There is normally no restrictions on using the eye if the patient feels no adverse effects from doing so.
Insurance should help cover the costs of this type of surgery, but a patient should always communicate with the insurance company prior to having surgery done. Since the iris implant is not FDA approved for public distribution in the United States yet, insurance may not cover the costs.
I will update this document as the process continues.
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