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SuspendedNCT01547442Updated Aug 28, 2024

Artisan Aphakia Lens for the Correction of Aphakia in Children

An interventional study of Artisan Aphakia Intraocular Lens in Aphakia, sponsored by Ophtec USA. Suspended at 19 sites in 2 countries. Open to participants aged 2 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by Ophtec USA · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
2 Years to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aphakia

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Keywords

  • aphakia
  • secondary intraocular lens
  • congenital cataract
  • marfan syndrome
  • pediatric cataract
  • ectopia lentis
  • subluxated lens
03

Who can participate

Ages eligible
2 Years to 21 Years
Sexes eligible
All
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Artisan Aphakia Intraocular Lens

    Implantation of an Artisan intraocular lens to correct aphakia in children

    Device: Artisan Aphakia Intraocular Lens

Interventions

  • DeviceArtisan Aphakia Intraocular Lens

    Implantation of an intraocular lens

05

What researchers measure

Primary outcomes

  1. Best corrected distance visual acuity at 12 months postoperative

    Determination of the ability of the lens to correct refractive error caused by aphakia

    Time frame: 5 years follow up

06

Study locations

19 sites
  • Phoenix Children's Hospital
    Phoenix, Arizona 35016, United States
  • The Vision Center
    Los Angeles, California 90027, United States
  • Indiana University, Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • Harvard University, Boston Children's Hospital
    Boston, Massachusetts 02115, United States
  • University of Minnesota, MN Lions Children's Eye Clinic
    Minneapolis, Minnesota 55454, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Children's Mercy Hospital and Clinics
    Kansas City, Missouri 64111, United States
  • Washington University, St. Louis Children's Hospital
    Saint Louis, Missouri 63110, United States
  • Rosenthal Eye and Facial Plastic Surgery
    Great Neck, New York 11023, United States
  • New York Medical College, Westchester Medical Center
    Valhalla, New York 10595, United States
  • Nationwide Children's Hospital, Pediatric Ophthalmology Associates
    Columbus, Ohio 43205, United States
  • University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital
    Mayfield Heights, Ohio 44124, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15224, United States
  • Medical University of South Carolina, Storm Eye Institute
    Charleston, South Carolina 29425, United States
  • University of Texas, Southwestern Medical Center
    Dallas, Texas 75390, United States
  • University of Texas, Robert Cizik Eye Clinic
    Houston, Texas 77030, United States
  • Moran Eye Center
    Salt Lake City, Utah 84132, United States
  • Credit Valley Eyecare
    Mississauga, Ontario L5L 1W8, Canada
07

Registry details

Key details

Study ID
NCT01547442
Lead sponsor
Ophtec USA
Responsible party
Sponsor
First posted
Mar 7, 2012
Start date
Jan 2012
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 28, 2024

Study contacts

Abraham Farhan
study director · Sponsor GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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