Information for Prospective Participants
INFORMATION FOR PARTICIPANTS
Rosenthal Eye Surgery and Facial Plastic Surgery
Principal Investigator: Kenneth J. Rosenthal, MD FACS
Clinical Research Coordinators: Danielle Kramer and Jessica Mesa
Study Title:
“Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects”
Device Manufacturer: HumanOptics AG/ Dr. Schmidt Intraocularlinsen GmbH
ClinicalTrials.gov Identifier: NCT01860612
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 in the United States 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 investigational artificial iris is designed to reconstruct the iris/pupil in order to minimize or eliminate visual disturbances and provide functional vision. Due to the current limitations in the 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.
ALTERNATIVE TREATMENTS
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.
If you have any questions or would like further information, please feel to contact our Clinical Research Coordinators, Danielle Kramer or Jessica Mesa, at crc@eyesurgery.org or 516-466-8989.
CLINICAL EXAMPLES: HumanOptics CustomFlex Artificial Iris Implant
Kenneth J. Rosenthal, MD FACS
The following are examples of subjects that have had HumanOptics CustomFlex Artificial Iris Implant and results may vary.
64 year old female status post tennis ball injury OS (left eye). The patient underwent lensectomy/vitrectomy/scleral buckle, and suffered complete loss of the iris. Subsequently, we implanted a sutured Intraocular Lens (IOL) with a CustomFlex Artificial Iris.
Rosenthal Eye Surgery and Facial Plastic Surgery
Principal Investigator: Kenneth J. Rosenthal, MD FACS
Clinical Research Coordinators: Danielle Kramer and Jessica Mesa
Study Title:
“Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects”
Device Manufacturer: HumanOptics AG/ Dr. Schmidt Intraocularlinsen GmbH
ClinicalTrials.gov Identifier: NCT01860612
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 in the United States 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 investigational artificial iris is designed to reconstruct the iris/pupil in order to minimize or eliminate visual disturbances and provide functional vision. Due to the current limitations in the 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.
ALTERNATIVE TREATMENTS
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.
If you have any questions or would like further information, please feel to contact our Clinical Research Coordinators, Danielle Kramer or Jessica Mesa, at crc@eyesurgery.org or 516-466-8989.
CLINICAL EXAMPLES: HumanOptics CustomFlex Artificial Iris Implant
Kenneth J. Rosenthal, MD FACS
The following are examples of subjects that have had HumanOptics CustomFlex Artificial Iris Implant and results may vary.
64 year old female status post tennis ball injury OS (left eye). The patient underwent lensectomy/vitrectomy/scleral buckle, and suffered complete loss of the iris. Subsequently, we implanted a sutured Intraocular Lens (IOL) with a CustomFlex Artificial Iris.
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.
Kenneth J. Rosenthal, MD, FACS
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New York City Address Fifth Avenue EyeCare and Surgery 1115 Fifth Avenue New York, NY, 10128 (212) 517-4500 crc@eyesurgery.org |