Now available in the U.S.
View the before and after pictures below.
Post iatrogenic trauma
Albino with dark device (untreated eye and treated eye)
A CUSTOM IRIS PROSTHESIS FINALLY GAINS FDA APPROVAL
Download the article below to find out what this approval means for U.S. surgeons.
Each CUSTOMFLEX® ARTIFICIALIRIS device is custom made for each individual patient.
The CUSTOMFLEX® ARTIFICIALIRIS device is a foldable iris prosthesis that is custom-made for each individual patient by HumanOptics AG (Erlangen, Germany). The CUSTOMFLEX® ARTIFICIALIRIS prosthesis is manufactured from a commercially available ophthalmic silicone. Colorized silicone paste is applied by hand in a pattern to match the color of the natural iris using a photograph of the existing iris or, in the case of aniridia, the color of the photograph selected by the patient. This custom color-match provides a cosmetically acceptable aesthetic restoration with high patient satisfaction.
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CUSTOMFLEX® ARTIFICIALIRIS Anterior View and Dimensions
CUSTOMFLEX® ARTIFICIALIRIS device is manufactured as a full 360º iris prosthesis with an overall diameter of 12.8 mm, which can be trephined as needed to custom-fit the device for placement in the ciliary sulcus or capsular bag.
The CUSTOMFLEX® ARTIFICIALIRIS is available in two models, With Fiber or Fiber Free. The two models are identical in every respect except that the With Fiber model has a polyester meshwork layer embedded in it to provide adequate tear strength to withstand suturing. The Fiber-Free model is suitable for sutureless implant techniques or can be sutured.
Indications for Use
The CUSTOMFLEX® ARTIFICIALIRIS is intended for use as an iris prosthesis for the treatment of iris defects. The CUSTOMFLEX® ARTIFICIALIRIS is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia.
CUSTOMFLEX® ARTIFICIALIRIS CLINICAL TRIAL SUMMARY
The clinical study that supported the FDA approval of the CUSTOMFLEX® ARTIFICIALIRIS is significant in that it represents the first controlled clinical trial of the CUSTOMFLEX® ARTIFICIALIRIS and is the largest known case series world-wide of eyes treated with an iris prosthesis.
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The clinical study was a prospective, non-masked, non-randomized multicenter study to determine the safety and effectiveness of the CUSTOMFLEX® ARTIFICIALIRIS for the treatment of full or partial iris defects. The study included 44 pediatric eyes and 403 adult eyes with a history of congenital aniridia and acquired iris defects, including but not limited to traumatic iris defects and traumatic mydriasis.
Gender for all eyes treated showed a predominance of males (64.0%; 286/447) compared to females (36.0%; 161/447); and, ethnicity was 89.0% (398/447) Caucasian, with smaller numbers of Hispanic (4.0%; 18/447), Asian (2.9%; 13/447), African-American (1.8%; 8/447), and the remainder self-described as being of another nationality or mixed race (1.6%; 7/447).
The With-Fiber and Fiber-Free models of the CUSTOMFLEX® ARTIFICIALIRIS were implanted with equal frequency in the pediatric eyes; whereas, the Fiber-Free model was used slightly more often than the With-Fiber model in the adult eyes and overall study cohort in the AI-001 study.
Blue and brown were the predominant eye colors for the implanted devices in both the pediatric and adult eye groups, followed by hazel. Black devices were manufactured and implanted in eyes which had albinism with a non-pigmented iris that was translucent and poorly functioning for blocking light transmission, resulting in a deep blue iris color postoperatively due to the contrast between the existing translucent iris and black implant.
The incidence of adverse events, complications, and other ocular or vision-related observations in the study was small. Visual symptoms were reduced, and visual function was increased compared to baseline after the CUSTOMFLEX® ARTIFICIALIRIS was implanted. Specifically, at 12 months after CUSTOMFLEX® ARTIFICIALIRIS implantation:
- There was an overall improvement in photosensitivity symptoms, quality of life and vision in pediatric and adult subjects.
- The CUSTOMFLEX® ARTIFICIALIRIS implant was correctly positioned in at least 95% of the pediatric and adult eyes throughout the 12-month study.
- Overall, there was a decrease in the proportion of eyes with marked to severe ratings for each of the evaluated visual symptoms: day-time light sensitivity, night-time light sensitivity, difficulty driving at night, reading difficulty, double vision, fluctuation in vision, glare during the day, glare at night, halos during the day, halos at night, starbursts, eye dryness, pain, and foreign body sensation after CUSTOMFLEX® ARTIFICIALIRIS implantation compared to before surgery. For pediatric eyes, there was a decrease in the proportion of eyes with marked to severe ratings for each visual symptom, except eye dryness increased. There were no pediatric eyes with marked to severe pain or foreign body sensation preoperatively or at 12 months.
- There was an improvement in health related quality of life, as measured by the NEI VFQ-25, in the pediatric and adult eyes.
- Postoperative cosmesis was aesthetically pleasing, with 94% of the overall cohort and 100% of the pediatric subjects rating the appearance of their eyes as improved, much improved, or very much improved.
- Postoperative inflammation resolved by 1 month in the majority of all eyes treated, as well as the pediatric eyes; 92% or more of the pediatric and adult eyes had no or trace cell or flare, 90% of pediatric and adult eyes had no corneal stromal edema; and, at least 96% of pediatric and adult eyes had no corneal wound edema at 1-month.
- Mean endothelial cell density remained stable with no clinically significant loss over the 12 months of the study in the pediatric and adult eyes.
- IOP was well controlled in the majority of eyes; mean postoperative IOP was within 1.5 mm Hg of mean preoperative IOP at all visits for the overall cohort and within 2.6 mm Hg for the pediatric eyes.
- Spikes of IOP >30 mm Hg were the most commonly reported adverse events following surgery, device or IOL related IOP increases >30 mm Hg occurred in less than 8% (35/447) of all the treated eyes and in none of the pediatric eyes.
- Although the CUSTOMFLEX® ARTIFICIALIRIS is not a refractive device, 65% (215/330) of all eyes and 55% (24/44) of pediatric eyes gained 1 or more lines of BSCVA; 67% (170/253) of all eyes and 64% (16/25) of pediatric eyes gained 1 or more lines of UCVA; and, mean MRSE was -0.36 D for all eyes and -0.83 D for pediatric eyes at 12 Months postoperatively.
- Few eyes lost BSCVA; 6.5% (2/31) of pediatric and 7.9% (26/330) of the overall study eyes lost 2 or more lines of BSCVA postoperatively compared to their preoperative vision at 12 months; and, none of the losses were related to the CUSTOMFLEX® ARTIFICIALIRIS.
- Visual symptoms generally improved at 1 month postoperatively. Furthermore, these outcome measures were maintained or improved with further follow-up through 12 months postoperatively.
- Pediatric subjects had postoperative safety and effectiveness outcomes that were equivalent or better than adults.
- All key safety and effectiveness endpoints were met and achieved statistical significance for all eyes treated and for the pediatric eyes. Results for the key safety and effectiveness endpoints and other study outcomes were similar in the pediatric eyes, adult eyes, and the overall study population.
PRODUCT SAFETY INFORMATION
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The CUSTOMFLEX® ARTIFICIALIRIS device is contraindicated in eyes with any of the following conditions:
- Uncontrolled ocular inflammation (e.g., uveitis)
- Severe chronic uveitis
- Untreated retinal detachment
- Untreated chronic glaucoma
- Rubella cataract
- Rubeosis of the iris
- Proliferative diabetic retinopathy
- Stargardt’s retinopathy
- Pregnancy in women
- Intraocular infections
Implantation of the CUSTOMFLEX® ARTIFICIALIRIS is not recommended in patients with the following conditions and situations:
- Children who are less than 3 years of age because their eyes are still in a stage of major growth development that would be disrupted by ocular surgery
- Preoperative intraocular pressure (IOP) above 21 mm Hg that does not respond to pressure-lowering medication, unless the IOP above 21 mm Hg is due to a known underlying condition that is well-controlled with glaucoma treatment, such as ocular hypertension or open angle glaucoma
- Patients with severe endothelial corneal dystrophy, because the surgery to implant the CUSTOMFLEX® ARTIFICIALIRIS may damage the cornea sufficiently such that the potential benefits of implantation do not outweigh the risks
- No useful vision or visual potential in the fellow eye, unless the patient has debilitating visual symptoms so that the potential benefits of CUSTOMFLEX® ARTIFICIALIRIS implantation clearly outweigh the risks
- Presence of a condition or finding in the contralateral eye that would make it unsafe to implant a CUSTOMFLEX® ARTIFICIALIRIS prosthesis in the eye to be treated
- Allergy to any of the planned postoperative antibiotic or anti-inflammatory medications, unless a suitable alternative medication can be prescribed
- Implantation for cosmetic color changes of the iris
- Post-partum women who are nursing or lactating and for whom postoperative medications are contraindicated
- Patients with gastric ulcers or diabetes mellitus in whom high doses of orally administered systemic steroids are required postoperatively
- Any other condition that would interfere with the planned surgical procedure to implant the artificial iris
The CUSTOMFLEX® ARTIFICIALIRIS should be used with caution in the following situations:
- A clear natural crystalline lens
- The visual potential of the fellow eye cannot be evaluated preoperatively (e.g., poor visual acuity due to cataract)
- Preoperative IOP > 21 mm Hg that is known to be stable and well controlled with glaucoma treatment (e.g., medication, tubes or shunts)
- Presence of any other medical condition that might be expected to make the patient an unsuitable candidate for CUSTOMFLEX® ARTIFICIALIRIS implantation
- Anticipated complexity of the planned surgical procedure that might increase the potential for complications
- Implantation in the fellow eye before stabilization of the first implanted eye (typically 1 month or more)
- Safety and effectiveness of intraocular lenses (IOLs) have not been established in pediatric patients in the U.S.
- The aperture of the CUSTOMFLEX® ARTIFICIALIRIS pupil is fixed at 3.35 mm. In the event that a larger pupillary opening is required for future posterior segment surgery, the CUSTOMFLEX® ARTIFICIALIRIS can be explanted and a new CUSTOMFLEX® ARTIFICIALIRIS may be implanted in the same surgical setting or as a separate procedure. The technique for the secondary implantation would be determined in the same manner as for a primary implantation.
The CUSTOMFLEX® ARTIFICIALIRIS implant is MR Unsafe.