Artisan Aphakia Lens for the Correction of Aphakia in Children



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:2 - 21
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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The purpose of this study is to determine the safety and effectiveness of the Artisan
Aphakia Lens in the treatment of aphakia in children.


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
We found this trial at
16
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Houston, TX
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Baltimore, Maryland 21009
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Columbus, OH
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Great Neck, New York 11023
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Indianapolis, IN
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Kansas City, Missouri 64108
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Mayfield Heights, OH
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Mississauga, Ontario
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Salt Lake City, Utah 84132
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