EXTRA LIFE-CHANGING RESULTS
FOR YOUR PATIENTS WITH ANIRIDIA AND IRIS DEFECTS
With the premium ARTIFICIALIRIS platform, you get the optimal treatment option for patients with complete and partial aniridia and iris defects. This unique foldable implant provides the solution for medical and aesthetic rehabilitation.1
A success story that has helped more than 7,500 patients to date achieve demonstrably life-changing results.
THE SUCCESS STORY OF ARTIFICIALIRIS
MDR Certification for ARTIFICIALIRIS
Official launch of ARTIFICIALIRIS SELECT
ARTIFICIALIRIS CUSTOMFLEX® has been approved for reimbursement in France
More than 4,200 ARTIFICIALIRIS CUSTOMFLEX®
implants worldwideARTIFICIALIRIS CUSTOMFLEX® has received reimbursement in the U.S.
FDA Approval ARTIFICIALIRIS CUSTOMFLEX®
1,000 ARTIFICIALIRIS implants in more than 40 countries
CE Approval ARTIFICIALIRIS
1. Implantation of an
ARTIFICIALIRIS in the
USA
Official Launch
of ARTIFICIALIRIS
1. Implantation of an
ARTIFICIALIRIS Fiber
Free
World's first implantation of an ARTIFICIALIRIS with Fiber by Prof. H.-R. Koch (Germany)
ETIOLOGY OF ANIRIDIA
Complete or partial aniridia may be congenital or acquired as a result of trauma or disease.
Impairment caused by aniridia:
- Loss of vision2
- Increased sensitivity to glare2
- Loss of Depth of Field2
- Negative effects on quality of life2
ETIOLOGY OF ANIRIDIA
Complete or partial aniridia may be congenital or acquired as a result of trauma or disease.
Impairment caused by aniridia:
- Loss of vision2
- Increased sensitivity to glare2
- Loss of Depth of Field2
- Negative effects on quality of life2
How can these issues be mitigated or completely resolved using the ARTIFICIALIRIS ?
MEDICALLY EFFECTIVE THANKS TO EXTRA-CONTROLLED LIGHT INGRESS
The regulated light transmission reduces visual symptoms such as light sensitivity and glare. 3
It can be used to treat transillumination defects.1
The medical efficacy of the ARTIFICIALIRIS CUSTOMFLEX® has been clinically confirmed. The implant has been accredited with the CE mark and approved by the FDA (U.S. Food and Drug Administration).
In 2022, the implant celebrated its 20th anniversary.
CONFIRMED BY CLINICAL STUDIES
of patients report a significant improvement in their sensitivity to light and glare.3
70% of patients were very satisfied or satisfied with their appearance.3
HOW THE ARTIFICIALIRIS WORKS
- Total diameter 12.8 mm – designed for custom sizing to suit the specific implant site
- Ultra-thin design made of biocompatible silicone with optional reinforcement via embedded fabric – for maximum flexibility in handling and use
- Fixed pupil aperture of 3.35 mm – an average value for all lighting conditions
- Opaque black back surface – for 100% light absorption4
HUMANOPTICS COLOR CHART SELECT – QUICK AND EASY COLOR SELECTION
Our ARTIFICIALIRIS SELECT implants are unique, handcrafted premium iris implants with a 3D structure. They are available in 9 predefined, multicolored combinations:
BROWN, BLUE, GREEN in the shades LIGHT, MEDIUM, DARK
Thanks to stock availability, they enable rapid and urgent patient care. Color selection is straightforward using the specially designed HumanOptics Color Chart SELECT.
BENEFITS OF ARTIFICIALIRIS SELECT
Fast delivery
Easy ordering
Premium quality
CAN'T FIND A MATCH? DISCOVER THE ARTIFICIALIRIS CUSTOMFLEX®
Replicating the natural appearance of the patient's eye by:
- Custom, tailor-made coloring
- 3D structure based on the natural structure of the iris
FACTS ABOUT THE ARTIFICIALIRIS
TWO MODELS FOR MAXIMUM FLEXIBILITY
The ARTIFICIALIRIS SELECT enables the highest level of patient-specific care. In addition to the appearance, the application options can also be flexibly tailored to the anatomy and initial condition of the affected eye.
Because no two cases are alike: choose the right model based on the specific indication:
ARTIFICIALIRIS FIBER FREE - THE STANDARD SOLUTION
The flexible option for implantation in the capsular bag and ciliary sulcus, as well as variations with suture fixation. Designed for cases where suture fixation is not indicated; suture fixation is possible using the appropriate technique.
ARTIFICIALIRIS WITH FIBER - FOR SPECIAL INDICATIONS
For the treatment of aniridia in cases where suture fixation is indicated.
Used to provide greater stability and tensile strength in specialized prosthetic applications.
APPLICATION
SUITABLE FOR INJECTION MOLDING
The ARTIFICIALIRIS SELECT is made of highly biocompatible, flexible silicone material that has been clinically proven over the past two decades. It can be implanted in a folded or rolled state using a small-incision technique.
DRILLABLE
The ARTIFICIALIRIS SELECT has a total diameter of 12.8 mm and can be customized in shape and size to match the specific iris defect.
Discover our coordinated selection of trephines:
Diameter: 8.0–12.5 mm
Graduation: 0.5 mm
Additional models available upon request.
IMPLANTATION METHODS – A WIDE RANGE OF OPTIONS
The ARTIFICIALIRIS SELECT offers a wide range of implantation methods, tailored to the specific conditions of the affected eye.1 Stay flexible—even during the procedure. The iris implant can be combined with virtually all IOL models.
ARTIFICIALIRIS SELECT, IOL and capsulorhexis ring in the capsular bag
ARTIFICIALIRIS SELECT, in the sulcus, IOL in the capsular bag
ARTIFICIALIRIS SELECT and IOL fixed separately in the sulcus
IOL on ARTIFICIALIRIS SELECT fixed, implantation in the sulcus
SURGERY VIDEOS
SURGICAL VIDEOS ARTIFICIALIRIS: Sulcus implantation – without suture fixation
- Implantation ARTIFICIALIRIS using a sclera-fixed Carlevale IOL
Courtesy of Prof. Dr. Lyubonmyr Lytvynchuk, Germany - Implantation without suture fixation using the Yamane technique
Courtesy of Prof. W. J. Mayer, Germany - Traumatic aniridia – implantation with forceps
Courtesy of Prof. H.-R. Koch, Germany - Congenital Aniridia – Implantation with Forceps
Courtesy of Prof. H.-R. Koch, Germany - Pseudophakia – Implantation with forceps
Courtesy of Prof. S. Kaminski, Switzerland - CTR application – Implantation with forceps – bilateral postoperative view
Courtesy of Dr. H. Hashemi, Iran - Loading the injector and implantation
Courtesy of Dr. M. Snyder, USA - Clear cornea – Implantation with injector
Courtesy of Dr. C. Mayer, Germany - Scleral tunnel – Implantation with injector
Courtesy of Dr. C. Mayer, Germany
ARTIFICIALIRIS: Sulcus implantation – with suture fixation
- Implantation of ARTIFICIALIRIS and IOL in 2 steps
Courtesy of Prof. C. Mayer, Germany - Fixation of ARTIFICIALIRIS and IOL via scleral pockets
Courtesy of Dr. M. Dominguez, France - Implantation of ARTIFICIALIRIS with Carlevale IOL
Courtesy of Prof. Peter Szurman, Germany
ARTIFICIALIRIS: Implantation into the capsular bag
- Implantation of ARTIFICIALIRIS CUSTOMFLEX ® and IOL into the capsular bag
Courtesy of Dr. S. Roman, France
ORDERING PROCESS
Submit order
To place an order, we need:
- Certification number upon completion of the online certification course (OCC)
- Model selection as specified
- Specify the desired SELECT color
Easy color selection with the HumanOptics color chart – no photo of the patient’s eye required.
Please send the order form to:
HumanOptics Holding AG
Spardorfer Str. 150
91054 Erlangen
EXPERT OPINION ON ARTIFICIALIRIS
“As expected, the vast majority of patients showed a significant reduction in glare and light sensitivity.”5
“Complications such as CME and similar issues occurred remarkably rarely. In our study, CME actually occurred in just under 3% of cases, which I find quite astonishing given the truly diseased eye cohort we see in these patients.”5
Dr. Michael E. Snyder, MD at Cincinnati Eye Institute.
“The artificial iris prosthesis has set a new standard in the reconstruction of complex anterior segment pathologies involving partial or complete aniridia. Our patients benefit from improved visual function, reduced glare, and a satisfactory cosmetic appearance. The latter is important and legitimate, considering that trauma patients are usually young and long for a cosmetically acceptable result.”6
Prof. Dr. Peter Szurman, Sulzbach Eye Clinic.
“A key advantage of the ARTIFICIALIRIS is the wide range of applications: scleral or sulcus fixation, as a full or partial prosthesis. This makes it possible to design customized solutions for a wide variety of initial conditions. The result can thus be equally characterized by surgical elegance and aesthetic beauty .”7
Prof. Dr. med. Urs Voßmerbäumer, Department of Ophthalmology, Frankfurt am Main (Höchst).
“The versatile silicone implant allows for a wide variety of implantation methods and surgical techniques, regardless of the IOL implantation.”8
Prof. Christian Mayer, M.D., University Eye Clinic, Heidelberg.
“Plastic reconstruction is medically necessary. It serves to improve quality of life by correcting visible defects and restoring lost body functions. Success is measured by the restoration of function and quality of life. For me as a surgeon, the ARTIFICIALIRIS offers a unique opportunity to restore the anterior segment of malformed or severely traumatized eyes to a previously unattainable aesthetic standard, with or without the implantation of an intraocular lens. The cosmetic result is often so good that patients subsequently require certification from an ophthalmologist. For example, for the young female driver who, due to a pupil that does not react to light, is repeatedly asked by observant police officers to undergo drug screening. Or for the aniridia patient who, following bilateral iris reconstruction, now has to have her passport updated to reflect her new eye color: light blue.” 9
Prof. Dr. med. Bernhard Stoffelns, FEBO, Mainz.
FIND YOUR ARTIFICIALIRIS EXPERT HERE
Just click on a location near you
Click on the location marked in blue to contact your preferred representative directly.
IMPORTANT
The ARTIFICIALIRIS SELECT is not intended for cosmetic changes to eye color. It has been designed for implantation in the posterior chamber of the eye and is not suitable for placement in the anterior chamber. It is strongly recommended that the ARTIFICIALIRIS SELECT be inserted into the eye only after removal of the natural lens and IOL implantation.
The ARTIFICIALIRIS is intended for use in adults and children aged 6 years and older and for the treatment of complete or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with complete or partial aniridia.
- Ayres BD, Fant BS, Landis ZC, Miller KM, Stulting RD, Cionni RJ, Fram NR, Hamilton S, Hardten DR, Koch DD, Masket S, Price FW Jr, Rosenthal KJ, Hamill MB, Snyder ME. Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris. Ophthalmology. 2022 Jun;129(6):614-625.
- Mayer C, Scharf D, Khoramnia R. Austausch von Aniridie-IOL gegen individuelle Iris-IOL-Implantate [Exchange of aniridia IOLs for customized iris IOL implants]. Ophthalmologe. 2022 Feb;119(2):181-189.
- HumanOptics Data on File, Clinical Study Report: Study AI-001 (n=447 eyes), 2018.
- HumanOptics Data on File, Test Report: Transmittance Study of Artificial Iris, 2013.
- Provencher L, Snyder ME. Custom Artificial Iris Clinical Trial. American Academy of Ophthalmology; July 29, 2022.
- Persönliches Statement.
- Persönliches Statement.
- Mayer C, Tandogan T, Hoffmann AE, Khoramnia R. Artificial iris implantation in various iris defects and lens conditions. J Cataract Refract Surg. 2017 Jun;43(6):724-731.
- Persönliches Statement.