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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:4/21/2016
Start Date:January 2012
End Date:December 2021
Contact:Fred Wassenburg
Email:f.wassenburg@ophtec.com
Phone:561-989-8767

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Artisan Aphakia Lens for the Correction of Aphakia in Adults

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

Not desired

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
We found this trial at
12
sites
Sioux Falls, South Dakota 57105
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Sioux Falls, SD
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Beverly Hills, California 90210
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Beverly Hills, CA
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Great Neck, New York 11023
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Great Neck, NY
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Jeffersonville, Indiana 47130
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Jeffersonville, IN
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Los Angeles, California 90067
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Los Angeles, CA
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Memphis, TN
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Mississauga, Ontario
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Mississauga,
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New York, New York 10021
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New York, NY
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Salt Lake City, Utah 84132
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Salt Lake City, UT
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San Antonio, Texas 78229
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San Antonio, TX
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Valhalla, NY
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