Artisan Aphakia Lens for the Correction of Aphakia in Children

Paused · Not applicable

Conditions studied: Aphakia

In brief

The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.

Key facts

Study ID

NCT01547442

Run by

Ophtec USA

People needed

300

Starts

2012-01-01

Expected to finish

2025-12-01

Last updated by the study team

2024-08-28

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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
• Pregnant, lactating or plan to become pregnant

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• The Vision Center — Los Angeles, California, United States
• Indiana University, Riley Hospital for Children — Indianapolis, Indiana, United States
• Harvard University, Boston Children's Hospital — Boston, Massachusetts, United States
• University of Minnesota, MN Lions Children's Eye Clinic — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
• Washington University, St. Louis Children's Hospital — St Louis, Missouri, United States
• Rosenthal Eye and Facial Plastic Surgery — Great Neck, New York, United States
• New York Medical College, Westchester Medical Center — Valhalla, New York, United States
• Nationwide Children's Hospital, Pediatric Ophthalmology Associates — Columbus, Ohio, United States
• University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital — Mayfield Heights, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina, Storm Eye Institute — Charleston, South Carolina, United States
• University of Texas, Southwestern Medical Center — Dallas, Texas, United States
• University of Texas, Robert Cizik Eye Clinic — Houston, Texas, United States
• Moran Eye Center — Salt Lake City, Utah, United States
• Credit Valley Eyecare — Mississauga, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.