Artisan Aphakia Lens for the Correction of Aphakia in Children

Description

The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.

Study Start Date

January 2012

Estimated Completion Date

December 2021

Interventions

  • Device: Artisan Aphakia Intraocular Lens

Specialties

  • Ophthalmology: Peds Ophthalmology,Retina

MeSH Terms

  • Aphakia

Study ID

Ophtec USA -- Artisan Pediatric Aphakia

Status

Recruiting

Trial ID

NCT01547442

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

300

Sponsor

Ophtec USA

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 3.2mm
  • Uncontrolled glaucoma
  • IOP > 25mm Hg
  • 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

Gender

Both

Ages

2 Years to 21 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (22)

Study Location Distance Name Phone Email
New York Medical College Westchester Medical Center - Valhalla, New York 28.9 miles None None None
Rosenthal Eye and Facial Plastic Surgery - Great Neck, New York 38.6 miles None None None
Rosenthal Eye and Facial Plastic Surgery - Great Neck, New York 38.6 miles None None None
Harvard University Boston Childrens Hospital - Boston, Massachusetts 135.8 miles None None None
Harvard University Boston Childrens Hospital - Boston, Massachusetts 135.8 miles None None None
Johns Hopkins Wilmer Eye Institute - Baltimore, Maryland 255.5 miles None None None
Johns Hopkins Wilmer Eye Institute - Baltimore, Maryland 255.5 miles None None None
University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh - Pittsburgh, Pennsylvania 354.7 miles None None None
University Hospitals Case Medical Center Rainbow Babies and Childrens Hospital - Mayfield Heights, Ohio 436.6 miles None None None
University Hospitals Case Medical Center Rainbow Babies and Childrens Hospital - Mayfield Heights, Ohio 436.6 miles None None None
Nationwide Childrens Hospital Pediatric Ophthalmology Associates - Columbus, Ohio 518.1 miles None None None
Indiana University Riley Hospital for Children - Indianapolis, Indiana 686.4 miles None None None
Indiana University Riley Hospital for Children - Indianapolis, Indiana 686.4 miles None None None
Medical University of South Carolina Storm Eye Institute - Charleston, South Carolina 691.2 miles None None None
Washington University St Louis Childrens Hospital - St. Louis, Missouri 919.8 miles None None None
University of Minnesota MN Lions Childrens Eye Clinic - Minneapolis, Minnesota 1,041.2 miles None None None
University of Minnesota MN Lions Childrens Eye Clinic - Minneapolis, Minnesota 1,041.2 miles None None None
Childrens Mercy Hospital and Clinics - Kansas City, Missouri 1,137.2 miles None None None
Childrens Mercy Hospital and Clinics - Kansas City, Missouri 1,137.2 miles None None None
University of Texas Southwestern Medical Center - Dallas, Texas 1,414.8 miles None None None
University of Texas Robert Cizik Eye Clinic - Houston, Texas 1,475.7 miles None None None
Moran Eye Center - Salt Lake City, Utah 2,001.2 miles None None None

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