Artisan Aphakia Lens for the Correction of Aphakia in Children
1 other identifier
interventional
300
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 28, 2024
August 1, 2024
13.9 years
February 27, 2012
August 27, 2024
Conditions
Keywords
Outcome Measures
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
5 years follow up
Study Arms (1)
Artisan Aphakia Intraocular Lens
EXPERIMENTALImplantation of an Artisan intraocular lens to correct aphakia in children
Interventions
Implantation of an intraocular lens
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ophtec USAlead
Study Sites (19)
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
St 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Abraham Farhan
Sponsor GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 7, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
August 28, 2024
Record last verified: 2024-08