FDA
Approves CustomFlex Artificial Iris
The FDA approved the first
Artificial Iris implant for patients with congenital aniridia (absence of an iris) or eye damage, called the
CustomFlex from
HumanOptics AG, a German firm. The
CustomFlex is a flexible silicone membrane that is folded and inserted through a small incision in the eye, then unfolded in place.
In a non-randomized clinical trial of 389 adult and pediatric patients with
Iris defects, the treated persons reported “decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis”, according to the FDA.
The
CustomFlex is patient-tailored to appear like an actual iris, with 94% of patients being satisfied with its appearance. The custom design either matches the contralateral healthy eye, or is selected by the patient in cases of bilateral aniridia. It has the advantage of being inserted into the ciliary sulcus or anterior chamber of the eye with a 2.75 mm-wide incision, compared to other implants that require up to 9.5 mm.
Patients with
Iris aniridia suffer from blurred vision, light sensitivity, eye watering, as well as risks of increased intraocular pressure and glaucoma. 70% of patients with the implant reported less light hypersensitivity and better quality of life. The congenital disorder, called congenital aniridia, is an improper development of the
Iris of the eye during development. It involves a gene called Paired Box gene 6 (
PAX6) and affects 1 in 64,000 to 100,000 people. For these patients and those who’ve experienced eye trauma, the
CustomFlex offers an opportunity to improve how they see and are seen.
Announcement:
FDA approves first artificial iris
Product page:
ArtificialIris*(CustomFlex)…
Related study:*
Implantation of ArtificialIris, a CustomFlex irisprosthesis, in a trauma patient with an Artisan lens…
