Colored iris implant

  • Colored Iriens Implant - Is It Possible To Change Eye Color?

 

 

Colored iris implants, inserted for aesthetic purposes in order to change the color of the eyes, represent a real public health problem. Unlike functional iris implants used in cases of traumatic or iatrogenic aniridia which are positioned in the sulcus or capsular bag, cosmetic colored implants are positioned on a healthy iris and in direct contact with the iriscorneal angle. Developed in Panama, the “New Color Iris” (figure 1) have apparently been implanted in more than 700 patients who made the trip to Panama between 2006 and 2010 in order to undergo a bilateral surgery. Many published clinical cases have reported complications related to the placement of these implants.

Complications of colored iris implants:

Fifty percent of the patients who benefited from the "New Color Iris" developed glaucoma, cataracts, uveitis, whether or not associated with endothelial decompensation. Despite the removal of the implant, more than half of the patients required secondary intervention such as endothelial corneal transplant, penetrating keratoplasty, filtering surgery or cataract surgery.

 

Implant irien coloré "New color iris"
Figure 1: Implant irien de première génération

More recently, a new iris implant, the “BrightOcular” (figure 2) replaced the “New Color Iris”. Its size is between 11.5 and 13.5mm, for a thickness varying between 0.3 and 0.5mm. It is used in nearly 10 countries outside of Europe and the United States. The company's website communicates that the implant is made from material approved by the FDA. However, no study has validated the safety of the use of these implants. One study reports the results of 12 patients who received Brightocular implants: 80% developed anterior uveitis, 58% glaucoma and 50% endothelial decompensation requiring corneal transplantation.

 

Figure 2: Appearance of the eyes with blue "Bright Ocular" iris implant. Note the corneal edema on the left eye caused by the implant.
Bottom left, aspect of the bright ocular implant under a biomicroscope.
Bottom right: Explantation of a bright ocular implant through a micro-incision.
Figure 2B.JPG

Explantation technique of a colored "Bright Ocular" iris implant

 

It is relatively easy to remove these silicone implants (figure 2, video). Through a 3 mm micro-incision, the implant is sectioned using 23 gauge scissors. It can then be removed through the microincision as it's flexible.

 

Are iris implants authorized in France?

No, the iris implants for cosmetic purposes are not allowed, neither in France nor in most countries of the European Union. They are to be distinguished from "Human Optics" iris implants which aim to correct congenital or acquired pathologies leading to aniridia (partial or total absence of iris). These have the CE marking and have a perfect place in reconstructive surgeries of the anterior segment.

 

The colored iris implants have an important media campaign, combined with a presence on social networks and indirect support of celebrities who have benefited from their implantation even though no serious study has proven safe and many cases of serious complications have been reported. The company BrightOcular speak on their website of a "brief, safe and painless" procedure while no scientific study has confirmed these statements. Today, it is essential to inform patients of the risks associated with the placement of such implants and to carry out strict monitoring of patients who have benefited from them.

Eye complications related to conjunctival tattoos:

 

 

Episcleral tattooing is a technique consisting in injecting a dye into the subconjunctival space, the objective being mainly cosmetic. The technical gesture is generally not carried out by a surgeon or by personnel trained in the ophthalmological environment. It is done without a surgical microscope with the risk of globe penetration, traumatic cataracts, retinal detachment or endophthalmitis.

Short-term complications reported include headache, photophobia and a persistent foreign body sensation. More severe, infections and perforation of the eyeball have been described. In the longer term, the literature speculates on the risk of a local inflammatory granulomatous reaction associated with scleral thinning, allergic reactions, uveitis or the possibility of migration of the dye into the surrounding tissues, at the iridocorneal angle with a risk of associated glaucoma, or at the level of the optic nerve with the risk of optic nevritis.

It is important today to properly assess the risks associated with such practices and to inform patients who may be interested in them.

 

Eye complications related to conjunctival whitening surgeries

The conjunctival whitening procedures initially described for the treatment of hyperhemias in chronic conjunctivitis consist of a large resection of the conjunctiva associated with a resection of the Tenon's capsule more or less associated with the use of Mitomycin C (MMC) per or postoperatively. The goal of using MMC is to reduce the risk of scarring. This technique was mainly performed in South Korea, with results published in 2013 on nearly 1,700 patients. The main complications reported include scleral thinning, calcified plaque formation, fibrovascular proliferation, ocular hypertension, and recurrence of conjunctival hyperemia. Cases of necrotizing scleritis have been described up to 4 years after surgery. In March 2014, ASCRS issued a press release recommending the use of other techniques to treat conjunctival hyperemia.