Artisan Aphakia Lens for the Treatment of Aphakia in Children

This study is currently recruiting participants.
Verified November 2013 by Ophtec USA
Information provided by (Responsible Party):
Ophtec USA Identifier:
First received: February 27, 2012
Last updated: November 5, 2013
Last verified: November 2013

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
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


Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Please refer to this study by its identifier: NCT01547442

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

No publications provided

Responsible Party: Ophtec USA 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:
Lens Diseases
Eye Diseases processed this record on April 15, 2014