Artisan Aphakia Lens for the Correction of Aphakia in Children

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 Overview

• Status: Suspended
• Conditions: Aphakia
• Intervention / Treatment: Device: Artisan Aphakia Intraocular Lens

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5L 1W8
      • Credit Valley Eyecare
• United States
  • Arizona
    • Phoenix, Arizona, United States, 35016
      • Phoenix Children's Hospital
  • California
    • Los Angeles, California, United States, 90027
      • The Vision Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University, Riley Hospital for Children
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard University, Boston Children's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota, MN Lions Children's Eye Clinic
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Children's Mercy Hospital and Clinics
    • Saint Louis, Missouri, United States, 63110
      • Washington University, St. Louis Children's Hospital
  • New York
    • Great Neck, New York, United States, 11023
      • Rosenthal Eye and Facial Plastic Surgery
    • Valhalla, New York, United States, 10595
      • New York Medical College, Westchester Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital, Pediatric Ophthalmology Associates
    • Mayfield Heights, Ohio, United States, 44124
      • University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina, Storm Eye Institute
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas, Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • University of Texas, Robert Cizik Eye Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Moran Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected distance visual acuity at 12 months postoperative	Determination of the ability of the lens to correct refractive error caused by aphakia	5 years follow up

Collaborators and Investigators

• Sponsor: Ophtec USA
• Investigators: Study Director: Abraham Farhan, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimated): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: aphakia; secondary intraocular lens; congenital cataract; marfan syndrome; pediatric cataract; ectopia lentis; subluxated lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia
• Other Study ID Numbers: Artisan Pediatric Aphakia