Georgia Eye Partners has expanded its services to include CUSTOMFLEX® ARTIFICIALIRIS, an FDA-approved, custom-made iris prosthesis in the United States for iris defects.
“This innovative solution not only restores a natural iris appearance but also effectively tackles symptoms of aniridia, ultimately enhancing the daily lives of our patients,” said Dr. Evan Schoenberg, who offers the procedure to patients.
What Is CUSTOMFLEX® ARTIFICIALIRIS?
The CUSTOMFLEX® ARTIFICIALIRIS is a foldable iris prosthesis custom-made for each individual patient, replicating the natural appearance of the patient’s eye. It is intended for use as an iris prosthesis for the treatment of iris defects.
The CUSTOMFLEX® ARTIFICIALIRIS is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia. When implanted, the CUSTOMFLEX® ARTIFICIALIRIS mimics the natural iris and produces an improvement in the visual symptoms associated with aniridia that most affect the patient’s quality of life.
Effectiveness
In a non-randomized clinical trial of 389 adult and pediatric patients who had the CUSTOMFLEX® ARTIFICIALIRIS implanted in one or both eyes for the treatment of congenital aniridia or other iris defects (Sponsor Clinical Research Consultants, Inc.), more than 70% of the study patients reported decreases in light sensitivity and glare, as well as improvement in health-related quality of life. In surveys, 94% of the study patients rated the appearance of their eyes as improved, much improved, or very much improved after the iris prosthesis was implanted.
Benefits
One of the probable benefits of the CUSTOMFLEX® ARTIFICIALIRIS treatment is that symptoms related to light sensitivity and vision may improve. Patients may also be able to function better and more easily perform normal activities that require useful vision. 12 months after the patients in the clinical trial underwent the CUSTOMFLEX® ARTIFICIALIRIS surgery, there was a decrease in the severity of day-time and night-time symptoms of light sensitivity, glare and halos.
“We are excited about the potential of this new procedure to enhance the quality of life for patients by addressing the visual effects of aniridia that impact them the most,” said Dr. Schoenberg. “This aligns perfectly with our commitment to delivering patient-centered care, and we couldn’t be more pleased to continue this mission.”
Who Is a Candidate?
The CUSTOMFLEX® ARTIFICIALIRIS is surgically implanted for the treatment of aniridia in children and adults who are born with aniridia or have iris defects that occur as the result of injuries or other conditions in which the iris becomes damaged or non-functional.
Patients may be a good candidate for CUSTOMFLEX® ARTIFICIALIRIS treatment if they are at least 3 years of age or older, have a diagnosis of congenital or acquired full or partial iris defect in the eye to be treated, have symptoms of light sensitivity, photophobia, and/or glare in the eye to be treated or other medically necessary indication for treatment, or if the eye to be treated either already has an IOL in place, has no lens, or is scheduled to undergo cataract extraction before or concurrently with the artificial iris surgical procedure.
