Artisan Aphakia Lens for the Treatment of Aphakia in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ophtec USA
Sponsor:
Information provided by (Responsible Party):
Ophtec USA
ClinicalTrials.gov Identifier:
NCT01547442
First received: February 27, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Aphakia
Device: Artisan Aphakia Intraocular Lens
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Artisan Aphakia Lens for the Correction of Aphakia in Children

Further study details as provided by Ophtec USA:

Primary Outcome Measures:
  • Uncorrected visual acuity at 1 year postoperative [ Time Frame: 5 years follow up ] [ Designated as safety issue: Yes ]
    Determination of the ability of the lens to correct refractive error caused by aphakia


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment for Aphakia
Implantation of an Artisan intraocular lens to correct of aphakia in children
Device: Artisan Aphakia Intraocular Lens
Implantation of an intraocular lens

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
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 3.2mm
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547442

Locations
United States, Florida
Ophtec Usa Recruiting
Boca Raton, Florida, United States, 33487
Contact: Jean Pak, MBS    561-989-8767    jean.pak@usa.ophtec.com   
Principal Investigator: Lawrence Tychsen, MD         
Sponsors and Collaborators
Ophtec USA
Investigators
Study Director: Rick McCarley Sponsor GmbH
  More Information

No publications provided

Responsible Party: Ophtec USA
ClinicalTrials.gov Identifier: NCT01547442     History of Changes
Other Study ID Numbers: Artisan Pediatric Aphakia
Study First Received: February 27, 2012
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ophtec USA:
aphakia IOL secondary IOL pediatriac cataract

Additional relevant MeSH terms:
Aphakia
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014