Artisan Aphakia Lens for the Correction of Aphakia in Children

Aphakia Clinical Trial

Official title:

Artisan Aphakia Lens for the Correction of Aphakia in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01547442
• Other study ID #: Artisan Pediatric Aphakia
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: December 2025

Study information

• Verified date: June 2022
• Source: Ophtec USA
• Contact: Abraham Farhan
• Phone: 561-989-8767
• Email: abraham.farhan[@]usa.ophtec.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• Artisan Aphakia Intraocular Lens
Implantation of an intraocular lens

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ophtec USA

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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