Artisan Aphakia Lens for the Correction of Aphakia in Children

Ophtec USA (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

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
  • Device: Artisan Aphakia Intraocular Lens
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
300 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Artisan Aphakia Lens for the Correction of Aphakia in Children
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Best corrected distance visual acuity at 12 months postoperative [5 years follow up]

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

Eligibility Criteria


Ages Eligible for Study:
2 Years to 21 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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


Site City State Country Postal Code
1 The Vision Center Los Angeles California United States 90027
2 Indiana University, Riley Hospital for Children Indianapolis Indiana United States 46202
3 Johns Hopkins Wilmer Eye Institute Baltimore Maryland United States 20814
4 Harvard University, Boston Children's Hospital Boston Massachusetts United States 02115
5 University of Minnesota, MN Lions Children's Eye Clinic Minneapolis Minnesota United States 55454
6 Mayo Clinic Rochester Minnesota United States 55905
7 Children's Mercy Hospital and Clinics Kansas City Missouri United States 64111
8 Washington University, St. Louis Children's Hospital Saint Louis Missouri United States 63110
9 Rosenthal Eye and Facial Plastic Surgery Great Neck New York United States 11023
10 New York Medical College, Westchester Medical Center Valhalla New York United States 10595
11 Nationwide Children's Hospital, Pediatric Ophthalmology Associates Columbus Ohio United States 43205
12 University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital Mayfield Heights Ohio United States 44124
13 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
14 University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
15 Medical University of South Carolina, Storm Eye Institute Charleston South Carolina United States 29425
16 University of Texas, Southwestern Medical Center Dallas Texas United States 75390
17 University of Texas, Robert Cizik Eye Clinic Houston Texas United States 77030
18 Moran Eye Center Salt Lake City Utah United States 84132
19 UW-Madison Madison Wisconsin United States 53705
20 Credit Valley Eyecare Mississauga Ontario Canada L5L 1W8

Sponsors and Collaborators

  • Ophtec USA


  • Study Director: Abraham Farhan, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Ophtec USA Identifier:
Other Study ID Numbers:
  • Artisan Pediatric Aphakia
First Posted:
Mar 7, 2012
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022

Study Results

No Results Posted as of Jun 27, 2022