Artisan Aphakia Lens for the Correction of Aphakia in Children
- Conditions
- Aphakia
- Interventions
- Device: Artisan Aphakia Intraocular Lens
- Registration Number
- NCT01547442
- Lead Sponsor
- Ophtec USA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Artisan Aphakia Intraocular Lens Artisan Aphakia Intraocular Lens Implantation of an Artisan intraocular lens to correct aphakia in children
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
The Vision Center
🇺🇸Los Angeles, California, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas, Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Nationwide Children's Hospital, Pediatric Ophthalmology Associates
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Harvard University, Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
University of Texas, Robert Cizik Eye Clinic
🇺🇸Houston, Texas, United States
Indiana University, Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
University of Minnesota, MN Lions Children's Eye Clinic
🇺🇸Minneapolis, Minnesota, United States
Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Rosenthal Eye and Facial Plastic Surgery
🇺🇸Great Neck, New York, United States
Washington University, St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
New York Medical College, Westchester Medical Center
🇺🇸Valhalla, New York, United States
University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital
🇺🇸Mayfield Heights, Ohio, United States
Credit Valley Eyecare
🇨🇦Mississauga, Ontario, Canada
Medical University of South Carolina, Storm Eye Institute
🇺🇸Charleston, South Carolina, United States
Children's Mercy Hospital and Clinics
🇺🇸Kansas City, Missouri, United States