The Ophtec Artisan Aphakia Pediatric IOL Study
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 visual correction of aphakia (+10 diopters to +30 diopters) in children. Dr. Rosenthal will also serve as the U.S. medical monitor for this
study.
The ARTISAN® Aphakia Lens is a unique single piece lens manufactured from ultraviolet light absorbing polymethylmethacrylate (PMMA) designed for primary or secondary implantation into the aphakic human eye for the visual correction of aphakia (+10 diopters to +30 diopters, +14.5 to +24.5 in 0.5D increments) when placement of a posterior chamber intraocular lens in the posterior chamber is not indicated and when an anterior chamber angle fixated intraocular lens is determined to not be in the patient’s best interest.
Uniquely, this lens may also be exchanged atraumatically during the child’s growth period, in which their refractive error is changing without the need for very invasive surgery. The IOL can be unclipped (“de-enclavated”) from the iris with a simple, relatively atraumatic motion, and exchanged with a new IOL of appropriate power.
During a surgical procedure, the lens is affixed to the relatively immobile anterior mid - periphery of the iris stroma by two iridoplastic bridges with enclavation mechanisms. The optic portion of the lens is 5.0mm in diameter and biconvex in configuration. The optic carrier is elliptical in shape and has an overall length of 8.5mm with a slight anterior vault and a width of 5.4mm. One fixation mechanism (enclavation claw) is located on each side of the two peripheral supports.
Intraocular lenses have historically been used as replacements for the natural lens following cataract surgery, and for the vast majority have restored vision to a level enabling patients to regain normal activities soon after cataract surgery.
The primary difference between traditional IOLs and the ARTISAN® Aphakia lens is the location of the lens placement within the eye. Conventional IOLs are placed behind the iris in the capsular bag. If the capsular bag is not stable, these lenses may alternatively be placed in the ciliary sulcus or sutured to the sclera or iris. Other alternative IOL designs may be placed in the anterior chamber due to lack of capsular support. These anterior chamber IOLs have projections into the anterior chamber angle to support the lens. The unique design of the ARTISAN® Aphakia
lens attaches it directly to the iris stroma allowing it to sit flush with the iris while maintaining a distance from the delicate structures of the anterior chamber. It provides an alternative for posterior IOLs in cases of compromised capsulary bags and where angle fixated lenses are deemed an unsuitable option.
The ARTISAN® Aphakia (Iris Claw) has been used since its early introduction in 1978 in Europe and Asia for the correction of aphakia following cataract surgery as a primary or secondary implant. The unique design is intended to maintain a safe distance from the corneal endothelium and does not come in contact with the angle of the eye. Reports from surgeons who use the ARTISAN® lens design for the correction of aphakia suggest that these lenses provide final distant visual acuity results and levels of complications comparable to conventional lenses used for the correction of aphakia. The ARTISAN® Aphakia IOL is increasingly being used as the back-up lens of choice by many modern cataract surgeons outside the United States as it has been designed for either primary or secondary implantation after ICCE, ECCE and Phacoemulsification. Approximately 450,000 of these lenses have been implanted worldwide.
It is with this high level of confidence gained by surgeons using this lens in Europe and Asia that further clinical investigations are warranted to bring the availability of this unique lens to the United States.
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 516-5466-8989.
study.
The ARTISAN® Aphakia Lens is a unique single piece lens manufactured from ultraviolet light absorbing polymethylmethacrylate (PMMA) designed for primary or secondary implantation into the aphakic human eye for the visual correction of aphakia (+10 diopters to +30 diopters, +14.5 to +24.5 in 0.5D increments) when placement of a posterior chamber intraocular lens in the posterior chamber is not indicated and when an anterior chamber angle fixated intraocular lens is determined to not be in the patient’s best interest.
Uniquely, this lens may also be exchanged atraumatically during the child’s growth period, in which their refractive error is changing without the need for very invasive surgery. The IOL can be unclipped (“de-enclavated”) from the iris with a simple, relatively atraumatic motion, and exchanged with a new IOL of appropriate power.
During a surgical procedure, the lens is affixed to the relatively immobile anterior mid - periphery of the iris stroma by two iridoplastic bridges with enclavation mechanisms. The optic portion of the lens is 5.0mm in diameter and biconvex in configuration. The optic carrier is elliptical in shape and has an overall length of 8.5mm with a slight anterior vault and a width of 5.4mm. One fixation mechanism (enclavation claw) is located on each side of the two peripheral supports.
Intraocular lenses have historically been used as replacements for the natural lens following cataract surgery, and for the vast majority have restored vision to a level enabling patients to regain normal activities soon after cataract surgery.
The primary difference between traditional IOLs and the ARTISAN® Aphakia lens is the location of the lens placement within the eye. Conventional IOLs are placed behind the iris in the capsular bag. If the capsular bag is not stable, these lenses may alternatively be placed in the ciliary sulcus or sutured to the sclera or iris. Other alternative IOL designs may be placed in the anterior chamber due to lack of capsular support. These anterior chamber IOLs have projections into the anterior chamber angle to support the lens. The unique design of the ARTISAN® Aphakia
lens attaches it directly to the iris stroma allowing it to sit flush with the iris while maintaining a distance from the delicate structures of the anterior chamber. It provides an alternative for posterior IOLs in cases of compromised capsulary bags and where angle fixated lenses are deemed an unsuitable option.
The ARTISAN® Aphakia (Iris Claw) has been used since its early introduction in 1978 in Europe and Asia for the correction of aphakia following cataract surgery as a primary or secondary implant. The unique design is intended to maintain a safe distance from the corneal endothelium and does not come in contact with the angle of the eye. Reports from surgeons who use the ARTISAN® lens design for the correction of aphakia suggest that these lenses provide final distant visual acuity results and levels of complications comparable to conventional lenses used for the correction of aphakia. The ARTISAN® Aphakia IOL is increasingly being used as the back-up lens of choice by many modern cataract surgeons outside the United States as it has been designed for either primary or secondary implantation after ICCE, ECCE and Phacoemulsification. Approximately 450,000 of these lenses have been implanted worldwide.
It is with this high level of confidence gained by surgeons using this lens in Europe and Asia that further clinical investigations are warranted to bring the availability of this unique lens to the United States.
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 516-5466-8989.