Artisan Aphakia Lens for the Correction of Aphakia in Children
NCT ID: NCT01547442
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
300 participants
INTERVENTIONAL
2012-01-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Artisan Aphakia Intraocular Lens
Implantation of an Artisan intraocular lens to correct aphakia in children
Artisan Aphakia Intraocular Lens
Implantation of an intraocular lens
Interventions
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Artisan Aphakia Intraocular Lens
Implantation of an intraocular lens
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
21 Years
ALL
Yes
Sponsors
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Ophtec USA
INDUSTRY
Responsible Party
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Principal Investigators
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Abraham Farhan
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
The Vision Center
Los Angeles, California, United States
Indiana University, Riley Hospital for Children
Indianapolis, Indiana, United States
Harvard University, Boston Children's Hospital
Boston, Massachusetts, United States
University of Minnesota, MN Lions Children's Eye Clinic
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States
Washington University, St. Louis Children's Hospital
St Louis, Missouri, United States
Rosenthal Eye and Facial Plastic Surgery
Great Neck, New York, United States
New York Medical College, Westchester Medical Center
Valhalla, New York, United States
Nationwide Children's Hospital, Pediatric Ophthalmology Associates
Columbus, Ohio, United States
University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital
Mayfield Heights, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
University of Texas, Robert Cizik Eye Clinic
Houston, Texas, United States
Moran Eye Center
Salt Lake City, Utah, United States
Credit Valley Eyecare
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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Artisan Pediatric Aphakia
Identifier Type: -
Identifier Source: org_study_id
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