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

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

Detailed Description
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Not desired

Official Title
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Artisan Aphakia Lens for the Correction of Aphakia in Adults

Conditions
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Aphakia

Intervention / Treatment
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* Device: Artisan Aphakia Intraocular Lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraocular Lens Implantation for the Treatment for Aphakia<br>Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section | Device: Artisan Aphakia Intraocular Lens<br>* Implantation of lens to correct refractive error in aphakic eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in best corrected visual acuity |  | 3 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aphakia, secondary intraocular lens