Iris Implant Surgery: Everything You Need to Know

Iris implant surgery is a procedure in which a prosthetic iris replaces one that failed to develop normally or an iris that was damaged following an injury. The surgery can also be done for purely cosmetic reasons, meaning to change an eye color.

However, the use of artificial iris implants for non-medical purposes is considered risky and has not been approved the U.S. Food and Drug Administration (FDA)—at least not yet.

To minimize the risk, iris implant surgery is often done in conjunction with a cataract procedure, lens implant, or corneal transplant.

This article explains the circumstances under which iris implant surgery may not be the best idea and points out the possible risks. It also presents the alternate side: When the surgery is justified, how to prepare for it, and what to expect before, during and after the procedure.

What Is Iris Implant Surgery?

Iris implant surgery is an outpatient procedure used to insert a prosthetic iris into the eye under local anesthetic.

The technique was first developed in 1956 to repair iris defects due to congenital problems, illness, or injury. Research shows iris lens diaphragm implants help to restore working functions of the iris, including reducing glare and improving visual acuity.

Prosthetic iris implants used to improve visual acuity come in a few different varieties including:

• Iris lens diaphragm
• Endocapsular tension ring with fins
• Customized artificial iris

Most iris implants are available in a handful of stock colors, such as blue, green, brown, and black. Patients who require surgery in one eye may want to consider opting for a customized iris to better match their other eye's color.

Circumstances That Discourage Surgery

Artificial iris implants are only recommended for individuals with iris defects who do not have a clear lens. Most healthcare providers require the eye either has a cataract, is missing a lens (aphakic), or has an artificial lens (pseudophakic) to be a candidate for iris implant surgery. 

People who are missing an iris (aniridic) and have a clear lens are not good candidates for iris implants, because a working lens should not be sacrificed to correct an iris defect.

In addition, artificial iris implants are contraindicated in people for whom any of the following apply:

• Active eye infection
• Uncontrolled inflammation of the eye
• Eye disorders that cause the eye to be abnormal in size, shape, or function (such as microphthalmos or rubella cataract)
• Untreated retinal detachment
• Untreated chronic glaucoma
• Rubeosis of the iris
• Proliferative diabetic retinopathy
• Stargardt's retinopathy
• Pregnancy

Possible Risks

Functional prosthetic iris implants are designed for sulcus or intracapsular placement, while cosmetic implants are put in the anterior chamber over the iris.

Complication rates are low for functional iris implants, but higher for cosmetic implants. Risks of iris implants include:

• Reduced vision or blindness
• Elevated pressure inside the eye that can lead to glaucoma
• Cataracts 
• Cornea injury leading to vision problems
• Blurred vision and tearing due to inflammation of the iris

Purpose of Iris Implant Surgery

The iris is a colored ring of muscle fibers behind the clear cornea and in front of the lens in the eye. In addition to providing eye color, the iris contracts and expands to change pupil size. This controls the amount of light that gets in to improve focus at different distances. 

A compromised iris, therefore, can affect vision. Iris implant surgery is used to improve vision in patients with:

• Traumatic iris defects, such as from an injury or previous surgical procedure
• Congenital aniridia, a condition where a person is born missing one or both irises
• Iris coloboma, a hole or other defect in the iris
• Herpetic iris atrophy, damage from a herpes outbreak in the eye
• Surgical iris loss
• Ocular albinism, a genetic condition that reduces pigmentation of the iris

Most prosthetic iris implantation patients report experiencing a significant decrease in light and glare sensitivity and overall improvement in vision.

To ensure you are a good candidate for iris implant surgery, your ophthalmologist will perform a thorough eye examination. This may include:

• Visual acuity (eye chart) test
• Refraction to measure your prescription strength
• Tonometry to test intraocular pressure
• Gonioscopy to check the anterior chamber angle 
• Ophthalmoscopy to examine the peripheral retina 
• Specular microscopy to determine endothelium cell count

In addition, your healthcare provider will measure the anterior chamber depth, axial length, and corneal diameter, and take photographs to help match the iris color for customized implants.

The healthcare provider will also discuss your medical history including whether you have diabetes, hepatitis B or C, Behçet’s disease, collagen tissue diseases, or a previous uveitis attack and ask about current and past medications.

Unapproved Cosmetic Use

In some places, iris implants are also used to permanently change eye color for cosmetic purposes, such as changing brown eyes to blue. However, cosmetic iris implants are not approved in the United States or Europe due to surgery risks.

Though not advised, Americans desiring cosmetic eye color changing surgery sometimes travel out of the country (e.g., to Mexico, Panama, or Costa Rica) to have the procedure done—a practice known as medical tourism.

If you are seeking to change your eye color for cosmetic reasons, there are other options you can consider. In addition to colored contacts, eye color can be permanently changed using a laser that disrupts the top layer of your eye's melanin (pigment), the amount of which determines eye color/shade. With this, a brown eye will turn blue permanently.

While this may give you the look you desire, the American Academy of Ophthalmology warns the procedure carries risks of glaucoma, uveitis, and could lead to blindness.

How to Prepare

For many years, iris implants were only approved in the United States on a case-by-case basis under a compassionate use device exemption from the FDA—this meaning the agency had to OK your specific surgery.

That changed in 2018 when the CustomFlex Artificial Iris (by HumanOptics) was granted FDA approval for medical use. Made of thin, foldable medical-grade silicone, the prosthetic iris is custom-made for each individual patient, and healthcare providers can use it without further FDA review of a patient's case so long as they meet criteria for the surgery.

Still, for patients seeking iris implants for medical reasons, the path to surgery can be long and filled with red tape. Few healthcare providers are credentialed to perform the surgery in the United States, so you may spend time searching for one that is qualified and accessible to you.

In addition, there is no billing code for the procedure, meaning the surgeon cannot charge for insurance plans for it. Insurance may cover the cost of the prosthetic iris with prior authorization, but there is a good chance you may need to pay out of pocket.

Ordering and Scheduling

Prior to scheduling iris implant surgery, the ophthalmologist will need to take precise measurements and photos of your eyes to order the prosthetic. Since each iris implant is custom-made, the wait can be a few months. Once the order has shipped, the surgeon's office will contact you to schedule surgery.

You will not be allowed to drive after the surgery, so be sure to make arrangements for a ride home as soon as your surgery date is set.

What to Expect on the Day of Surgery

When you arrive at the outpatient facility, you will likely be asked to complete several forms and verify personal information.

Before the Procedure 

You will then be taken back to the procedure room and the healthcare provider will perform a brief examination. The surgeon will place numbing drops in your eyes. Your head will be strapped into a harness to keep your head still, and small device will be positioned to hold your eyelid open and prevent blinking.

During the Procedure

Once the numbing drops have taken effect, the surgeon will start the procedure. If you are having other work done alongside iris implant surgery, such as cataract surgery, the healthcare provider will begin with that and finish with the iris implant.

To implant the iris, the surgeon makes a small incision in the cornea where it meets the sclera (white part of the eye). The silicone iris is folded and inserted through the incision. The prosthetic is then unfolded and sutured into position over the natural iris.

After the Procedure

Once the surgery is ended, your healthcare provider will give you instructions about caring for your eye, which may include wearing dark glasses to protect against the light. You will also be prescribed eye drops to prevent infections and complications. You will then be sent home.

Recovery

Healing following iris implant surgery depends largely on the health of the eye prior to surgery. Most patients recover fully in a matter of weeks, provided there are no complications. Your healthcare provider will provide guidance for when you can resume normal activities again.

Follow all of your healthcare provider's instructions and call if you have any questions or concerns. Your healthcare provider will most likely ask you to come in for several follow-up visits to monitor your recovery.

Healing

Your eye may feel slightly gritty or scratchy for the first 24 to 48 hours after surgery. Your vision may be blurry and your eye may tear. Avoid touching and rubbing your eye. Your surgeon may advise you to sleep with a protective eye patch at night to prevent this.

Sensitivity to light is common after iris implant surgery and should abate within a few days. Your eye may also be slightly inflamed after the surgery which may cause slightly blurry vision to perpetuate for the first week or so.

Your healthcare provider will likely prescribe antibacterial drops or other medications to prevent infection. They may also recommend using lubricating drops, a cloth soaked in cold saline as a compress, or over-the-counter pain relievers like Tylenol (acetaminophen) to relieve post-surgical pain.

A Word From Verywell

Iris implant surgery should only be performed by a qualified and experienced ophthalmologist. It is currently only approved for medical reasons in the United States. If you are seeking cosmetic eye color changing surgery abroad, be sure to do your research into the facility and surgeon. If not done properly, iris implant surgery can lead to complications including blindness.