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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 : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ophtec USA

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
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

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Arms and Interventions
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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
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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
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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
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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
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Contact: Fred Wassenburg 561-989-8767 f.wassenburg@ophtec.com

Locations
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Sponsors and Collaborators
Ophtec USA
Investigators
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Study Director: Fred Wassenburg Sponsor GmbH
More Information
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Responsible Party: Ophtec USA
ClinicalTrials.gov Identifier: NCT01547442    
Other Study ID Numbers: Artisan Pediatric Aphakia
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Keywords provided by Ophtec USA:
aphakia
secondary intraocular lens
congenital cataract
marfan syndrome
 pediatric cataract
ectopia lentis
subluxated lens
Additional relevant MeSH terms:
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Aphakia
Lens Diseases
Eye Diseases