Summary

The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.

Conditions

  • Aphakia

Recruitment Status

SUSPENDED

Eligibility Criteria

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 study requirements
* 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 benefit of 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

Phase

NA

Gender

ALL

Min Age

2 Years

Max Age

21 Years

Download Date

2024-08-28

Principal Investigator

N/A

Intervention

Intervention Type

DEVICE

Intervention Name

Artisan Aphakia Intraocular Lens

Contact

For more information and to contact the study team:

Artisan Aphakia Lens for the Correction of Aphakia in Children NCT01547442