Ophtec iris reconstruction lens United States clinical trial phase I

doi:10.1016/j.ophtha.2004.04.023

Ophthalmology

Volume 111, Issue 10, October 2004, Pages 1847-1852

Presented in part at: American Academy of Ophthalomology Annual Meeting, November, 2003; Anaheim, California.

https://doi.org/10.1016/j.ophtha.2004.04.023 Get rights and content

Abstract

Purpose

To determine the safety and efficacy of the Ophtec model 311 iris reconstruction lens for treatment of visual disturbances, such as glare or photophobia, related to partial or total absence of the human iris.

Design

Phase I multicenter, nonrandomized, investigational device study.

Participants

Ten iris reconstruction lenses were placed in 10 subjects at 6 sites.

Methods

Iris reconstruction lenses were placed in 9 patients who had lost all or part of their iris from trauma and in 1 patient who lacked iris pigmentation due to congenital albinism. Patients were examined preoperatively, intraoperatively, and postoperatively at day 1; week 1; and months 1, 3, 6, and 12.

Main outcome measures

Efficacy measures were uncorrected visual acuity (UCVA), glare, starbursts, and photophobia. Safety measures were best-corrected visual acuity (VA), surgical complications, and adverse events.

Results

Uncorrected VA improved in all eyes after implantation of the iris reconstruction lens. Best-corrected VA did not change significantly (P = 0.24). Postoperative photophobia was reduced in all 9 eyes that experienced moderate to severe preoperative photophobia. Likewise, postoperative glare was reduced in all 6 eyes with moderate to severe preoperative glare. There were no surgical complications. Adverse events included 2 cases of iritis and 1 case of macular edema.

Conclusions

Preliminary results suggest that the Ophtec model 311 iris reconstruction lens can improve UCVA and reduce glare and photophobia in patients with partial or total absence of the iris or iris pigmentation.

Section snippets

Materials and methods

This was a prospective, multicenter, nonrandomized, phase I U.S. Food and Drug Administration investigational device study to evaluate the safety and efficacy of the model 311 iris reconstruction lens. The study was conducted with institutional review board approval. All subjects read and signed an informed consent form, and the work was compliant with the Health Insurance Portability and Accountability Act of 1996. The investigators who implanted lenses in the phase I study included the

Results

During the study, 10 iris reconstruction lenses were placed in 10 subjects, 3 female and 7 male. The subjects ranged in age from 27 to 70 years (mean, 45; standard deviation, 15).

Seven of the 10 study eyes had suffered blunt trauma, 2 had sustained surgical trauma, and 1 lacked iris pigmentation due to congenital albinism. All 10 eyes exhibited significant preoperative ocular pathology in addition to the iris defect (Table 1). Functionally, at least 75% of the iris was missing in 6 cases, 50%

Discussion

This study is the first U.S. multicenter study of an implantable artificial iris. Patients with partial or total aniridia are often desperate for improved vision and relief from light sensitivity. However, the relatively low incidence of congenital or traumatic aniridia has provided little incentive for major ophthalmic companies to seek approval of artificial iris devices in the United States due to the high costs associated with the approval process. Artificial iris implants have been

References (15)

R.H. Osher et al.
Cataract surgery combined with implantation of an artificial iris
J Cataract Refract Surg
(1999)
D.J. Tanzer et al.
Black iris-diaphragm intraocular lens for aniridia and aphakia
J Cataract Refract Surg
(1999)
C.G. Thompson et al.
Implantation of a black diaphragm intraocular lens for traumatic aniridia
J Cataract Refract Surg
(1999)
T. Reinhard et al.
Black diaphragm aniridia intraocular lens for congenital aniridialong-term follow-up
J Cataract Refract Surg
(2000)
I. Mavrikakis et al.
Phacoemulsification and endocapsular implantation of an artificial iris intraocular lens in traumatic cataract and aniridia
J Cataract Refract Surg
(2002)
Y.J. Chen et al.
Favorable outcome using a black diaphragm intraocular lens for traumatic aniridia with total iridectomy
J Cataract Refract Surg
(2003)
X. Dong et al.
Black diaphragm intraocular lens implantation in aphakic eyes with traumatic aniridia and previous pars plana vitrectomy
J Cataract Refract Surg
(2003)

There are more references available in the full text version of this article.

Cited by (37)

Light-adaptable artificial iris with dynamically scalable pupil-aperture function by radially patterned photochromic transition control
2024, Materials and Design
The iris is an ocular organ that actively controls the size of the pupil-aperture in response to external light, thereby regulating the amount of light reaching the retina for better visual acquisition. Herein, we propose a light-adaptive pupil-scalable artificial iris for addressing human iris defects with biomimetic self-regulating light control similar to human iris actuation, which is realized by a radially gradient and reversible photoswitching of photochromic dyes doped within a biocompatible hydrogel matrix. The radial photochromic switching of light transmissions was achieved by the gradient patterning of the crosslinking density of the hydrogel matrix using a near-infrared light-absorbing photomask that generated radially thermal gradience during hydrogel matrix polymerization. With the effective pupil-aperture control, the proposed artificial iris exhibited a variation in the visible-light transmittance from ∼82 % at the ultraviolet light (UV) intensity of 0.5 mW/cm² to ∼43 % at 3.0 mW/cm² representing the transparent and colored states, respectively. The switching times for the transitions to the colored and transparent states were 27.42 and 112.25 s, respectively, at a UV intensity of 3.0 mW/cm², which can be faster under the hydrated state. The artificial iris demonstrated potential in biomedical applications by offering reliable light-adaptive attenuation control through human-like pupil-aperture adjustments.
Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris
2022, Ophthalmology
To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects.
Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial.
Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both.
Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results.
Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery.
At the 12-month postoperative examination, a 59.7% reduction in marked to severe daytime light sensitivity (P < 0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P < 0.0001), a 53.1% reduction in marked to severe daytime glare (P < 0.0001), and a 48.5% reduction in severe nighttime glare (P < 0.0001) were found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery.
The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.
Novel surgical technique of sutureless artificial iris and intraocular lens scleral fixation using Yamane technique
2022, American Journal of Ophthalmology Case Reports
To describe a novel surgical technique of a combined implantation of an artificial iris and a scleral fixated intraocular lens (IOL) using flanged IOL haptics (“Yamane” technique).
The suturelessly implanted artificial iris-IOL-sandwich was stable with good functional as well as aesthetic results. However, our case showed a postoperative intraocular pressure rise.
The presented case demonstrates that a visual as well as cosmetical rehabilitation seems to be possible even after severe, penetrating ocular trauma with profound iris defects.
The sutureless IOL scleral fixation technique can also be used in combination with a sutureless artificial iris implantation. Further studies are needed to evaluate the long-term safety profile and rates of postoperative complications.
Flexible silicone artificial iris in cases of aniridia and iris deficiencies
2021, Journal Francais d'Ophtalmologie
To evaluate a customized silicone flexible artificial iris in cases of aniridia or iris deficiencies.
Centre Hospitalier National d’Ophtalmologie, Hôpital des Quinze-Vingts, Paris, France.
Retrospective case series investigating cosmetic result, photophobia, endothelial cell density and intraocular pressure.
Patients with iris deficiencies requiring cataract surgery or correction of aphakia, or pseudophakic patients, complaining of photophobia or cosmetic disturbances were implanted with the new flexible artificial iris.
Fifteen eyes of 14 patients were evaluated. Mean age was: 49.5 (±18.5). A total of 50% were aphakic, 22.4% pseudophakic and 28.6% phakic. Etiology was trauma (57.1%), previous surgical trauma (28.6%) and congenital aniridia (14.3%). Three months postoperatively, the mean subjective photophobia score improved by 5.2 points (P = .002) and the mean cosmesis score by 4.7 points (P = .001) on a 0 to 10 scale. Mean endothelial cell loss was 16% (P = .001). There was no further statistically significant endothelial cell loss between the 3-month follow-up and the 1-year follow-up visit (P = .320). Elevated intraocular pressure was the main complication (35.7%). Two patients with pre-existing glaucoma required cyclodestructive procedures. The artificial iris was removed in one eye because of chronic pain, elevated intraocular pressure and inflammation that resolved rapidly after removal.
Implantation of the customized artificial iris is a very good option because of its outstanding cosmetic result. However, patients with pre-existing glaucoma are not good candidates. Patients should also be warned of possible chronic inflammation necessitating explantation.
Évaluer un nouvel iris artificiel en silicone flexible en cas d’aniridie ou de déficience irienne.
Centre hospitalier national d’ophtalmologie, hôpital des Quinze-Vingts, Paris, France.
Étude retrospective étudiant le résultat cosmétique, la photophobia, la densité endothéliale et la pression intraoculaire.
Des patients, atteints de déficiences iriennes se plaignant de photophobie ou d’un probleme esthétique et nécessitant une chirurgie de cataracte, ont recu le nouvel iris artificiel en silicone flexible.
Quinze yeux de 14 patients on été evalué. L’âge moyen était de 49,5 années (±18,5). Un total de 50 % étaient aphaques, 22,4 % pseudophaques et 28,6 % phaques. L’étiologie était un traumatisme (57,1 %), un traumatisme chirugical (28,6 %) ou une aniridie congénitale (14,3 %). À 3 mois postoperatoire, sur une échelle de 0 à 10, la photophobie subjective moyenne s’est améliorée de 5,2 points (p = .002) et le résultat esthétique de 4,7 points (p = .001). la perte endothéliale était de 16 % (p = .001). Entre 3 mois et 1 an postopératoire il n’y avait plus de perte endotheliale significative (p = .320). L’ élévation de la pression intraoculaire était la complication principale (35,7 %). Deux patients souffrant d’un glaucome préexistant ont nécessité une cyclodestruction. L’iris artificiel a dû être retiré pour un patient du fait d’une pression élévée et d’une douleur associée à une inflammation chronique. Les symptomes ont disparus après l’ablation de l’iris artificiel.
L’implantation du nouvel iris artificiel est une bonne solution du fait de ses résultats esthétiques probants. Cependant, les patients atteints de glaucome préexistant ne sont pas de bons candidats. Les patients doivent être prévenus de la nécessité d’une possible explantation.
Complications of Cosmetic Artificial Iris Implantation and Post Explantation Outcomes
2021, American Journal of Ophthalmology
To report complications of cosmetic artificial iris implantation and explantation outcomes.
Retrospective case series.
Medical records of 12 patients (24 eyes) who presented to us after being implanted with cosmetic artificial irises elsewhere were reviewed. Data collected included baseline demographics, presenting symptoms, examination findings, and management outcomes.
Eight eyes had NewColorIris implants and 16 had BrightOcular implants. The mean interval from cosmetic iris implantation to presentation was 61.7 ± 60.0 months. The mean follow-up after explantation was 35.5 ± 38.1 months. Complications at presentation included iris abnormalities (11 eyes, 45.8%), elevated intraocular pressure (8 eyes, 33.3%), corneal edema (6 eyes, 25%), intraocular inflammation (5 eyes, 20.8%), and cataract (4 eyes, 16.7%). Surgical interventions included cosmetic iris removal (19 eyes, 79.2%), cataract extraction (7 eyes, 29.2%), corneal transplantation (7 eyes, 29.2%), and glaucoma surgery (4 eyes, 16.7%). Complications at the last follow-up examination included native iris defects (11 eyes, 45.8%), persistent glaucoma (7 eyes, 29.2%), cataract (5 eyes, 20.8%), corneal edema (4 eyes, 16.7%), and intraocular inflammation (2 eyes, 8.3%). The mean logarithm of the minimum angle of resolution was 0.56 ± 0.47 at presentation and 0.78 ± 0.88 at the last examination (P = .30). The mean intraocular pressure was 22.7 ± 15.8 mm Hg at presentation and 13.4 ± 6.99 mm Hg at the last examination (P = .02).
Cosmetic iris implantation was associated with serious complications at the time of presentation, and adverse sequelae persisted for years after explantation.
Safety and Efficacy of Colored Iris Reconstruction Lens Implantation
2020, American Journal of Ophthalmology
Citation Excerpt :
It consists of an opaque 9.0-mm diaphragm and a central, fixed 4.0-mm optic, which blocks excess light from entering the eye while allowing for examination of the peripheral retina via indirect ophthalmoscopy. The 2004 paper by Price and associates,15 which reported 1-year outcomes of a phase I clinical trial of the Ophtec device in the United States, showed improvements in UDVA, visual disturbances, and cosmetic appearance after device implantation. In 2007, Miller and associates16 confirmed those results in a 3-year follow-up study of 9 eyes that underwent combined penetrating keratoplasty and Ophtec 311 implantation.
We sought to evaluate the 1- to 9-year safety and efficacy of colored iris reconstruction lens implantation in eyes with visual disturbances caused by partial or complete aniridia.
Prospective, interventional case series.
Thirty-eight patients were implanted with Ophtec 311 colored iris reconstruction lenses at the University of California, Los Angeles as part of a larger U.S. Food and Drug Administration clinical trial. Patients in group 1 lacked corneal pathology. Patients in group 2 patients had corneal pathology, such as endothelial failure, previous transplants, or scarring. Safety measures included loss of corrected distance visual acuity (CDVA), surgical complications, adverse events, secondary interventions, and corneal endothelial cell loss. Efficacy measures included improvement in uncorrected distance visual acuity (UDVA) and subjective visual disturbances.
Groups 1 (n = 8) and 2 (n = 30) showed improvements in CDVA (P = .155 and .038), UDVA (P = .002 and P < .001), and subjective visual disturbance scores at year 3. Median CDVA and UDVA declined slightly for both groups after 1-2 years. Group 2 experienced more adverse events, surgical complications, and secondary interventions. Endothelial cell loss was greater for group 2 (19.7%) than group 1 (8.05%), although this difference was not statistically significant (P = .067).
Colored iris reconstruction lens implantation improved CDVA, UDVA, and subjective visual disturbances 3 years postoperatively and beyond. Adverse events, complications, and subsequent declines in visual acuity were common, however, in these eyes with complex medical and surgical histories.

View all citing articles on Scopus

^☆

Manuscript no. 240039.

The authors have no financial interests related to this article or devices mentioned therein.

The study was sponsored by Ophtec USA, Inc., Boca Raton, Florida.

View full text

Original articleOphtec iris reconstruction lens United States clinical trial phase I☆

Abstract

Purpose

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Section snippets

Materials and methods

Results

Discussion

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

Original article
Ophtec iris reconstruction lens United States clinical trial phase I☆