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Iris Reconstructive Lens

 

Ophtec 311 Iris Reconstructive Lens

This study is meant to demonstrate the safety and effectiveness of the Iris Reconstruction Lens for surgical correction of iris / lens disorders in patients.  Available by compassionate use under FDA regulations.

 

Background

Individuals who lack adequate iris tissue suffer from glare, photophobia, poor depth of field, and other visual disturbances that can cause social, mental, and/or economic problems. Artificial iris implants (Ophtec BV, Groningen, The Netherlands; Morcher, Stuttgart, Germany) have been used in Europe for over 10 years, and they have been available in the United States for approximately 5 years under special Compassionate Use Exemptions by the Food and Drug Administration.1–14 These implants are designed to treat congenital or traumatic iris defects.

    In 2002, Ophtec (Ophtec USA, Inc., Boca Raton, FL) initiated the first U.S. clinical trial of an artificial iris implant, the model 311 iris reconstruction lens (Fig 1), which is a single-piece implant made from clear and colored ultraviolet light–absorbing polymethyl methacrylate. It is designed for implantation into an aphakic or pseudophakic human eye for the correction of visual disturbances resulting from an incomplete or totally absent iris and the correction of spherical refractive error as necessary. The artificial irises are available in brown, blue, or green. Available powers range from 10.0 to 30.0 diopters (D) in 0.5-D increments. The lens is also available without power (plano). The opaque colored portion of the implant is 9.0 mm in diameter, whereas the central clear optic is 4.0 mm in diameter. The optic configuration is biconvex, and the anterior to posterior radius ratio depends on lens power. The implant has 2 C-loop haptics, each with an eyelet at the apex to provide the option to suture fixate the implant to the sclera. The uncompressed haptic diameter is 13.75 mm.

 

Indications (all of the following are required)

1. Congenital or acquired aniridia

2. Cataract, pseudophakia, or aphakia

3. Iris defect sufficiently large to cause photophobia, glare sensitivity,

contrast loss, blurred vision, or multiplopia

 

Contraindications (any one is sufficient)

1. Asymptomatic patient

2. Symptoms adequately treated by tinted glasses, tinted contact lenses,

or contact lenses with an artificial pupil

3. Phakic eye without cataract (unless the patient is willing to undergo

simultaneous clear lens extraction)

4. Iris defect small enough to close with sutures

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