The CustomFlex Iris is a customized Artificial Iris implant that is made from medical inert pigmented silicone elastomer material. This prosthetic iris implant is custom-made which means it is made specifically for each patient according to the color of the iris. It comes in one diameter of 12.8 mm and the surgeon can trim it to fit the size of the eye.
The color of the silicon should match the color of the natural iris either the remnants of the iris or the color of the iris of the other eye for the same patient but in case of aniridia, the color of artificial iris can be selected by the patient.
The CustomFlex Artificial Iris is used mainly in patients with aniridia. Aniridia is absence of the iris which can be complete or partial absence or congenital or acquired anirida. Acquired aniridia can occur after trauma and surgical removal of iris due to uveal melanoma.
You should know that this artificial iris implant has no refractive powers which means it can’t correct refractive errors such as myopia, hyperopia and astigmatism.
How does CustomFlex Iris work?
This artificial iris device is implanted inside the eye through small corneal incision. Your eye doctor will remove the natural lens or cataract from your eye and implant intraocular lens inside the capsular bag then the CustomFlex Artificial Iris is implanted in the sulcus ( space between the iris and capsular bag) or inside the capsular bag infront of the intraocular lens.
The doctor might use the whole artificial implant as in case of complete aniridia or in cases with partial aniridia he might trim it to fit inside the eye and to suture it with the remnants of the iris so that it will appear as complete iris. This implant has a fixed artificial pupil with a diameter of 3.35 mm to control the amount of lights enter inside the eye.
What are the benefits of CustomFlex?
1-Improve the cosmetic appearance of the eye.
2-Patients with aniridia always complain of glare and light sensitivity and both of them reduce the visual acuity and the best corrected vision. This implant helps to reduce both of them and improve the quality of vision.
Is CustomFlex Iris Implant suitable for everyone?
CustomFlex is approved by FDA for medical needs only and it can't be use for cosmetic purposes to change the eye color. Your eye doctor must be sure that this implant won’t cause any damage to your eye that might lead to permanent vision loss and in order to do that, full ocular examination before the surgery is required to be sure you don’t have any of the following:
1- Active or uncontrolled inflammation of the eye (Uveitis)
2- Small Eye or microphthalmia.
3- Untreated chronic Glaucoma.
4- Iris Rubeosis or new abnormal blood vessels that grow on the iris.
5- Untreated retinal detachment.
Types of CustomFlex Artificial Iris
1- CustomFlex With Fiber with polyester meshwork layer.
2- CustomFlex Fiber Free.
The polyester meshwork layer provides more stiffness and stability for suturing the implant inside the eye. The Fiber free implant is mainly used for sutureless surgical procedures.
Complications of CustomFlex Artificial Iris Implant
Some of these complications are related to the iris implant itself and some are related to the surgical procedure in general or both:
1- Inflammation, iritis and anterior uveitis with red eye and pain.
2- Increased intraocular pressure.
3- Photosensitivity and glare.
4- Corneal edema due to corneal decompensation that can end up with bullous keratopathy.
5- Decentrations, dislocation or malposition of the implant which might cause diplopia and reduction in visual acuity.
6- Macular edema.
7- Retinal detachment.