Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults

Ophtec

Status: Suspended

Conditions: Aphakia

Treatments: Device: Artisan Aphakia Intraocular Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01547429

Artisan Adult Aphakia

Details and patient eligibility

About

This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.

Full description

Not desired

Enrollment: 300 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
• Patient must agree to comply with the visit schedule and other requirements of the study

Exclusion criteria

• Patients that are not able to meet the extensive postoperative evaluation requirements
• Mentally retarded patients
• When the patient has no useful vision or vision potential in the fellow eye
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
• Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
• Patients with uncontrolled glaucoma
• High preoperative intraocular pressure, >25 mmHg
• Chronic or recurrent uveitis or history of the same
• Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
• Patients with a retinal detachment or a family history of retinal detachment
• Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye
• Diabetes mellitus
• Pregnant, lactating, or plans to become pregnant during the course of this study

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

Intraocular Lens Implantation for the Treatment for Aphakia

Experimental group

Description:

Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section

Treatment:

Device: Artisan Aphakia Intraocular Lens