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Aniridia

Overview

Aniridia is the partial or complete absence of the iris, which is the colored part of your eye. The iris regulates the amount of light that enters your eye. In low light conditions the pupil, or opening in the center of your iris, increases in size to let in more light. Conversely, in bright light, the pupil constricts to reduce the amount of light entering your eye.

What causes aniridia?

Sometimes the iris fails to develop properly due to a genetic defect – this is known as congenital aniridia. Aniridia can also result from trauma to the eye, because the iris is quite fragile – like the consistency of tissue paper. 

Symptoms

Aniridia usually causes light sensitivity and problems with glare, similar to what we all temporarily experience when we leave a movie matinee and step outside into the bright afternoon sunshine. This is because the lack of iris tissue allows too much light into the eye. In addition to causing light sensitivity, aniridia can also make it difficult to open the eye normally, and it reduces the depth of field normally provided by a small or medium pupil (similar to the aperture effect in a camera).

Treatments

Often surgeons can repair a traumatic iris defect with sutures. When iris repair is not feasible, an artificial iris can help provide relief from light sensitivity and glare.

Dr. Francis Price and his associates at Price Vision Group have specialized in taking care of aniridia patients, both congenital and traumatic, for over 25 years. Dr. Price is the Medical Monitor and the Cornea Research Foundation is participating in the first USA clinical research study of an artificial iris implant, the Ophtec Model 311. In this study, we found that 2/3 of the patients had traumatic aniridia and 1/3 had congenital aniridia. Many congenital aniridia patients have other associated abnormalities of the eye such as corneal scarring, glaucoma, early cataract development, and/or improper development of the macula and retina that can lead to poor vision. Often the attachments of the lens to the wall of the eye are abnormal leading to dislocation of the lens/cataract. Some patients also have nystagmus. The Cornea Research Foundation and Price Vision Group have long had an interest in helping aniridia patients and provide treatments for lack of iris tissue, corneal scarring, glaucoma and complicated cataracts.

Artificial Iris Lenses

Congenital and traumatic aniridia are relatively rare, so there has been little incentive for major ophthalmic companies to seek approval of artificial iris devices in the United States due to the high costs associated with the approval process. Artificial iris implants have been available in Europe for over 10 years and are available in the U.S. on a compassionate use basis.

Several artificial iris devices are available. Dr. Price is the Medical Monitor for the USA clinical study of the Ophtec Model 311, which is available in three colors: blue, brown or green. Morcher makes a black artificial iris that has been available for a number of years, but Morcher has not initiated a study to get this lens approved for use in the USA. A new artificial iris from Humanoptics provides the most attractive cosmetic appearance because it can be custom matched to the patient’s natural iris color. Humanoptics plans to initiate a USA clinical study in which the Cornea Research Foundation will participate.

We reported the initial results from the artificial iris study in the following publication:
Price MO, Price FW, Chang DF, Kelley KA, Olsan MD, Miller KM. Ophtec iris reconstruction lens United States clinical trial phase I. Ophthalmology, 2004, III; 1874-1852.

Ophtec Artificial Iris

One normal eye and one with artificial iris
One normal eye, one with an
artificial iris.
Artificial Iris
Artificial Iris
Before Implanted Iris
Before
After Implanted Iris
After
An artificial iris may help reduce glare and light sensitivity in people who are missing some, or all of the iris, which is the colored part of the eye.

Dr. Francis W. Price, Jr. is medical monitor for the first clinical trial evaluating use of the Ophtec artificial iris* in patients.  He implanted an Ophtec artificial iris in first study patient in 2002 and has been the surgeon who has consistently performed the most implants in the study. * Artificial Iris Implant is manufactured by Ophtec USA.

The Ophtec Artificial Iris Implant is made of PMMA, the most common type of plastic used to make hard contact lenses and artificial intraocular lenses to replace the natural lens. Until now, this plastic has been primarily used in cataract surgeries. The artificial iris comes in blue, green and brown. This new iris can block excess light from entering the eye so patients are not as easily incapacitated by glare and light sensitivity as they were before when they did not have a complete iris.

People who are most likely to benefit from this type of procedure are those with a missing iris, or an iris defect, or people whose iris has endured trauma. To date, most patients have been over the age of 21.  However, as Dr. Price recently pointed out, “The artificial iris can also benefit children who are born without an iris or who lose the iris in an accident.  It can help improve their vision and restore a more normal appearance. Enrollment in the study has been completed, but patients may still receive an artificial iris through a compassionate use exemption from the FDA.

*Artificial Iris Implant is manufactured by Ophtec USA.

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Learn more about Trischa’s new life and new vision.

Boy Gets Artificial Iris

Artificial Iris being implanted

by: Mary McDermott

(Indianapolis-February 1, 2005) - A five-year-old New York boy has come to Indianapolis for a chance to dramatically improve his vision.

Michael Cruz was born with troubled eyes. He does not have any irises - the part that would usually be blue, brown, green or hazel. The iris controls the amount of light that enters the eye. It is a ring-shaped tissue with a central opening, which is called the pupil.

In a normal eye, the pupil will constrict in bright light and dilate in dimmer light. For Michael, light in an ordinary room is too bright to see clearly because his eyes can’t filter it.

“Kind of like coming out of a movie matinee in the bright sun—you know how just devastating it is—you can’t keep your eyes open, you can’t lift your head up. And that’s the way these people are all the time from the time they’re born. So Michael doesn’t even realize what it’s like not to be that way,” said Dr. Francis Price, eye specialist.

Soon, though, Michael should see the world with new eyes. An operation he had at St. Vincent Hospital Tuesday morning gave him an artificial iris. He’s only the third child in the country to get such an implant.

“The artificial iris has a clear central area that’s visual, and an outer area that’s nine millimeters in diameter that’s opaque. It comes in blue, green, or brown, and his family chose brown for him,” said Dr. Price.
It was all part of a clinical trial involving 112 people who received artificial irises. Dr. Price has performed nearly half of those procedures. He expects Michael to heal quickly and he hopes the implants eventually get federal approval for wider use.

“I think it’s a tremendous asset for these people who have these conditions. It’s just phenomenal. Now, not everybody has a dramatic response but most of the people have a really dramatic improvement,” said Dr. Price.
Michael received one artificial iris Tuesday. He is scheduled to get the other one in a few months.

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