Artisan Aphakia Lens for the Correction of Aphakia in Children

Ophtec

Status: Suspended

Conditions: Aphakia

Treatments: Device: Artisan Aphakia Intraocular Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01547442

Artisan Pediatric Aphakia

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 2 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Artisan Aphakia Intraocular Lens

Experimental group

Description:

Implantation of an Artisan intraocular lens to correct aphakia in children

Treatment:

Device: Artisan Aphakia Intraocular Lens