FDA Clinical Trials

Our office participates in many FDA clinical trials and clinical research projects. If you are interested in learning more about this, please reach out to our office.

CustomFlex Artificial Iris Prosthesis

The human iris controls the amount of light entering the back portion of the eye.  Images formed from this light are projected onto the back of the eye, then converted to electrical energy and sent to the brain where sight occurs.  The absence of all or a portion of an iris can significantly reduce the quality of an image projected onto the back of the eye, which in turn can significantly diminish sight.  The purpose of this clinical study is to evaluate the ability of the investigational artificial iris implants to improve the quality of vision in eyes with partial or total iris loss.

Common causes of partial or total iris loss include trauma, disease, drug use and congenital anomalies. Visual symptoms associated with damaged, incomplete, or absent irises can range from mild disturbances when in special lighting conditions, to non-functional vision.  The investigational artificial iris that has been recommended for you is designed to create an artificial pupil, thereby reducing or eliminating light that can cause glare, halos, photophobia (sensitivity to light) and other visual disturbances.

Treatments for partial to total iris loss vary depending on the amount of remaining iris, the condition of surrounding tissues as well as visual potential.  Available treatments include doing nothing, prescribing custom colored contact lenses or surgically recreating the iris/pupil using sutures to draw the remaining iris together.  For many, these treatments perform satisfactorily and patients function with minimal effects to their daily life.  Others, however, do not benefit from available treatments and experience a significant reduction in their quality of life.

The artificial iris is designed to reconstruct the iris/pupil to minimize or eliminate visual disturbances and provide functional vision.  Due to the current limitations in technology a perfect cosmetic result may or may not be achieved.

The device has been recently approved by the Food and Drug Administration (FDA) and is manufactured outside the United States. Information regarding the device’s safety, efficacy, and whether the device has been manufactured according to FDA’s quality systems or other pertinent FDA regulations is continuing to be collected.


Before you decide to receive an Iris Prosthetic Implant, understand that the following treatment options are currently available:

1.  Do nothing:  All surgery has risks.  Choosing to do nothing eliminates these risks.  Technology may be developed in the future that offers a better solution.

2.  Colored contact lenses:  Custom made hard or soft contact lenses are placed on the surface of the cornea to create a functional pupil, which requires no surgery. However, many patients cannot wear contact lenses due to corneal disease or trauma and other patients may choose not to wear contact lenses due to disabilities, working conditions and or convenience.

3.  Suture reconstruction:  Surgery is performed to “stitch” together iris remnants in an effort to close an undesired opening in the iris or to decrease the size of the pupil.  However, in your particular case, Dr. Rosenthal’s opinion is that there is insufficient iris for this to be successfully accomplished.

CLINICAL EXAMPLES: HumanOptics CustomFlex Artificial Iris Implant

The following are examples of subjects that have had HumanOptics CustomFlex Artificial Iris Implant and results may vary.

17-year-old male with congenital aniridia (absence of the iris): Top photograph after implantation of CustomFlex iris OS (left eye); Bottom photograph, after bilateral implantation.  Visual acuity preoperatively was 20/100 Best Corrected Visual Acuity (BCVA) with nystagumus (involuntary eye movement) and foveolar hypoplasia (underdevelopment of the macula).  Post-operatively visual acuity was 20/30 OU (both eyes) with dampening of nystagmus.

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