Artisan Aphakia Lens for the Correction of Aphakia in Children

Inclusion Criteria:

• 2 to 21 years of age

• Have a visually significant cataract or need IOL replacement surgery

• Compromised capsular bag prohibiting implantation of standard posterior IOL

• Subject or parent/guardian must be able to comply with visit schedule and studyrequirements

• Subject's legal representative must be able to sign the Informed Consent

Exclusion Criteria:

• Under 2 years of age

• Unable to meet Postoperative evaluation requirements

• No useful vision or vision potential in fellow eye

• Mentally retarded patients

• History of corneal disease

• Abnormality of the iris or ocular structure

• ACD less than 3.2 mm

• Uncontrolled glaucoma

• IOP > 25 mmHg

• Chronic or recurrent uveitis

• Preexisting macular pathology that may complicate the ability to assess the benefitof this lens

• Retinal detachment or family history

• Retinal disease that may limit visual potential

• Optic nerve disease that may limit visual potential

• Diabetes mellitus

• Pregnant, lactating or plan to become pregnant