Information for Medical Professionals
ANNOUNCING A NEW FDA MONITORED CLINCIAL TRIAL:
The HumanOptics CustomFlex Artificial Iris Implant
I am pleased to announce that my practice has been selected as a study site for the FDA clinical trial of an innovative implantable device for the repair of iris defects or congenital iris anomalies: The HumanOptics CustomFlex Artificial Iris Implant.
As the co-inventor (along with Volker Rasch, MD of Potsdam, Germany) of the very first modular iris prosthesis intended for human implantation, I have had the benefit of 17 years of experience in the surgical treatment of iris defects. While the earlier models of iris implants are effective in treating visual problems such as glare, photophobia, starbursts and reduced visual quality, their cosmetic appearance left something to be desired, and often required incisions of up to 13mm.
The HumanOptics CustomFlex Artificial Iris is composed of flexible silicone, can be inserted through a sub 2.8mm incision and is meticulously handmade to match the coloration of either the patient's damaged eye, the fellow eye, or, in cases of complete aniridia, of the eye of an individual that the patient selects as a “model.” As a result of these innovations, the devices can be implanted under minimally invasive conditions and provides a nearly undetectable cosmetic match, allowing its use under expanded clinical applications.
Over the past several years, and prior to the approval of an Investigational Device Exemption by the FDA I have had the opportunity, (through the FDA’s Compassionate Use Device Exemption regulation), to implant a number of patients with this device, all with excellent results.
For more written information regarding the HumanOptics CustomFlex Artificial Iris please click here (or visit www.artificial-iris.com/surgeons). A few examples of the surgery which I have performed can be viewed on youtube (search for either “kjrmdfacs” or “artificial iris implant”) and this news feature regarding one of my previous patients who benefited greatly from this surgery.
If you wish to refer patients that you believe could benefit from this surgery, or have questions, please feel to contact our Clinical Research Coordinators, Danielle Kramer or Jessica Mesa, at crc@eyesurgery.org or 516-466-8989.
Sincerely,
Kenneth J Rosenthal, MD FACS
Principal Investigator
Pre- and post op photos of iris implant patients
The HumanOptics CustomFlex Artificial Iris Implant
I am pleased to announce that my practice has been selected as a study site for the FDA clinical trial of an innovative implantable device for the repair of iris defects or congenital iris anomalies: The HumanOptics CustomFlex Artificial Iris Implant.
As the co-inventor (along with Volker Rasch, MD of Potsdam, Germany) of the very first modular iris prosthesis intended for human implantation, I have had the benefit of 17 years of experience in the surgical treatment of iris defects. While the earlier models of iris implants are effective in treating visual problems such as glare, photophobia, starbursts and reduced visual quality, their cosmetic appearance left something to be desired, and often required incisions of up to 13mm.
The HumanOptics CustomFlex Artificial Iris is composed of flexible silicone, can be inserted through a sub 2.8mm incision and is meticulously handmade to match the coloration of either the patient's damaged eye, the fellow eye, or, in cases of complete aniridia, of the eye of an individual that the patient selects as a “model.” As a result of these innovations, the devices can be implanted under minimally invasive conditions and provides a nearly undetectable cosmetic match, allowing its use under expanded clinical applications.
Over the past several years, and prior to the approval of an Investigational Device Exemption by the FDA I have had the opportunity, (through the FDA’s Compassionate Use Device Exemption regulation), to implant a number of patients with this device, all with excellent results.
For more written information regarding the HumanOptics CustomFlex Artificial Iris please click here (or visit www.artificial-iris.com/surgeons). A few examples of the surgery which I have performed can be viewed on youtube (search for either “kjrmdfacs” or “artificial iris implant”) and this news feature regarding one of my previous patients who benefited greatly from this surgery.
If you wish to refer patients that you believe could benefit from this surgery, or have questions, please feel to contact our Clinical Research Coordinators, Danielle Kramer or Jessica Mesa, at crc@eyesurgery.org or 516-466-8989.
Sincerely,
Kenneth J Rosenthal, MD FACS
Principal Investigator
Pre- and post op photos of iris implant patients
64 year old female status post tennis ball injury OS. The patient underwent lensectomy/vitrectomy/scleral buckle, and suffered complete loss of the iris. Subsequently, we implanted a sutured IOL with a CustomFlex Artificial Iris.
17 year old male with congienital aniridia: Top photograph after implantation of CustomFlex iris OS; Bottom photograph, after bilateral implantation. Visual acuity preoperatively was 20/100 BCVA with nystagumus and foveolar hypoplasia. Post-operatively, visual acuity was 20/30 (both eyes) with dampening of nystagmus.