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Artisan Aphakia Lens for the Correction of Aphakia in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01547442
Recruitment Status : Recruiting
First Posted : March 7, 2012
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Aphakia Device: Artisan Aphakia Intraocular Lens Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artisan Aphakia Lens for the Correction of Aphakia in Children
Study Start Date : January 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Artisan Aphakia Intraocular Lens
Implantation of an Artisan intraocular lens to correct aphakia in children
Device: Artisan Aphakia Intraocular Lens
Implantation of an intraocular lens


Outcome Measures

Primary Outcome Measures :
  1. Best corrected distance visual acuity at 12 months postoperative [ Time Frame: 5 years follow up ]
    Determination of the ability of the lens to correct refractive error caused by aphakia


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547442


Contacts
Contact: Fred Wassenburg 561-989-8767 f.wassenburg@ophtec.com

Locations
United States, Indiana
Indiana University, Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 20814
United States, Massachusetts
Harvard University, Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota, MN Lions Children's Eye Clinic Recruiting
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Children's Mercy Hospital and Clinics Recruiting
Kansas City, Missouri, United States, 64111
Washington University, St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Rosenthal Eye and Facial Plastic Surgery Recruiting
Great Neck, New York, United States, 11023
New York Medical College, Westchester Medical Center Recruiting
Valhalla, New York, United States, 10595
United States, Ohio
Nationwide Children's Hospital, Pediatric Ophthalmology Associates Recruiting
Columbus, Ohio, United States, 43205
University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
United States, Pennsylvania
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Medical University of South Carolina, Storm Eye Institute Recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas, Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
University of Texas, Robert Cizik Eye Clinic Recruiting
Houston, Texas, United States, 77030
United States, Utah
Moran Eye Center Recruiting
Salt Lake City, Utah, United States, 84132
Canada, Ontario
Credit Valley Eyecare Recruiting
Mississauga, Ontario, Canada, L5L 1W8
Sponsors and Collaborators
Ophtec USA
Investigators
Study Director: Fred Wassenburg Sponsor GmbH
More Information

Responsible Party: Ophtec USA
ClinicalTrials.gov Identifier: NCT01547442     History of Changes
Other Study ID Numbers: Artisan Pediatric Aphakia
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016

Keywords provided by Ophtec USA:
aphakia
secondary intraocular lens
congenital cataract
marfan syndrome
pediatric cataract
ectopia lentis
subluxated lens

Additional relevant MeSH terms:
Aphakia
Lens Diseases
Eye Diseases