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January 2, 2020 | Author: Admin
Artificial iris implants are particularly used for both cosmetic and therapeutic purposes. In many cases, the iris implants simultaneously perform both the functions. Artificial iris anterior chamber implants were initially used for therapeutic purposes. However, in recent times, many people opt for artificial iris anterior chamber implants for cosmetic purposes, for instance, to change the color of the eye.
As the cosmetic use for iris anterior chamber implant has recently been increased, there are no studies to indicate the long-term risk and complications in context to vision. Various causes have been reported which concludes that iris implants may lead to vision-threatening complications. These complications may be seen many years after implants.
Therapeutic use of an artificial iris implant is done when the natural iris undergoes degeneration or damage. The probable cause for therapeutic iris implantation includes congenital or acquired defects. Many patients suffering from iris defects see several images ranging from clear to blurred. Quality of life in these patients is significantly reduced and the problem in iris also impacts visual contrast. The condition becomes more complex when these symptoms are clubbed with halos, glare, and increased light sensitivity. The light enters in eyes of these patients is defocused that impacts the quality of vision.
Congenital defects include congenital aniridia, congenital coloboma, iridocorneal endothelial syndrome, and oculocutaneous albinism. For these patients, to provide therapeutic and cosmetic benefits, USFDA has approved artificial iris implant. Not only the people with various congenital defects of iris would be benefitted but the patients who have acquired problems in iris either due to surgery or trauma may also be able to get the advantage. Injury or trauma to iris may include penetration of objects such as knife or scissors in the eye and blunt trauma including injury due to ball or fist.
USFDA has approved CustomFlex Artificial Iris (HumanOptics, Erlangen, Germany). The implant is made of foldable and thin medical-grade silicone. The device is currently available in the United States and its use is expected to increase in the next few years. Trained doctors for implanting the device, authentic success stories, and entry into the list of insurance companies for implant cost reimbursement are some of the growth drivers of artificial iris implant.
The device has a variety of benefits. These are customized to meet the need of the individual patient. The device is used to manage iris deformity not only due to congenital but also due to other reasons which include removal of iris due to melanoma. It helps in providing cosmetic as well as a therapeutic advantage in patients who suffer from complete or partial aniridia.
During the surgery, the CustomFlex Artificial Iris is implanted with the help of a small incision. The implanted iris may either be held through the normal anatomical structures of the eye or can be kept in place with the help of sutures. The artificial iris does a similar function as performed by the natural iris. The artificial implant also creates a pupil that regulates the amount of light entering the eye.
CustomFlex Artificial Iris offers various advantages to the patients, for instance, it reduces the light sensitivity, reduces glare and halos, improves the cosmetic appearance of the eye and significantly improves the overall quality of life.
Apart from the advantages, there are certain limitations to its use. The device is contraindicated in people who are suffering from underlying ocular conditions such as microphthalmus, have ocular infection or inflammation, diabetic retinopathy, abnormal growth of blood vessels in iris, Stargardt’s disease which is characterized by aggregation of cells in the vision area of the retina and if there is a pregnancy.
To implant the device, the surgeon should be well-trained in context to surgery, implantation, and post-surgical care. It is also to be noted that there should be no dilation of the pupil after the implant as the artificial iris implant does not dilate because of its plastic nature.
People requiring iris implants in a single eye may face the problem of matching. Sometimes the implant may be slightly lighter or slightly darker as compared to the natural eye. However, the matches are quite comparable and the difference is not visible until looking for minute deviations.
CustomFlex Artificial Iris comes in two models. One is CUSTOMFLEX® ARTIFICIALIRIS with Fiber and the other is CUSTOMFLEX® ARTIFICIALIRIS Fiber Free. Artificial iris with fiber is generally used in cases where suturing is indicated while fiber-free is implanted where no suturing is required. The total diameter of both the model is 12.8 mm with pupil diameter 3.35 mm. It is to be noted that this size may fit in maximum eyes. However, in patients with small eyes, surgical precision is required.
Size is of little importance when the suturing of the implant is done as large size can be sutured to keep the implant in place. However, in the case where the implant is placed in a capsular bag or sulcus without suture, sizing may play a significant role.
The patient must pass the eligibility criteria for getting the implant. Implanting the device in front of a clear lens may lead to cataract thus the patient requiring this implant should have a cataract. If the defect in the iris can be treated only through suture such patients are ineligible for getting the implant. However, patients with large defects along with cataracts are eligible candidates for an implant.
If the surgery of both the implant and the cataract is done simultaneously, the device is preferably be placed in the capsular bag. The implant provides exceptional results and improves the quality of vision and quality of life equally in both adults and children.
Apart from the therapeutic benefits, the device also provides a cosmetic advantage. It infuses the confidence in the patients who were wearing an eye patch or contact lenses to hide the iris defect. They were able to meet people without thinking about the problem in their eyes. This will improve their psychological health.
Yusrah Shweikh, Sally Ameen, and Ali Mearza. Complications secondary to cosmetic artificial iris anterior chamber implants: a case report. BMC Ophthalmol. 2015; 15: 97
https://www.fda.gov/medical-devices/recently-approved-devices/customflextm-artificial-iris-p170039
https://www.reviewofophthalmology.com/article/the-artificial-iris-in-practice
https://xtalks.com/humanoptics-customflex-artificial-iris-approved-as-breakthrough-device-1356/
https://www.mneye.com/cornea/artificial-iris-now-approved/
http://www.spectrumsurgical.com.au/artificial-iris/
