Clinical trial NCT01547442: Artisan Aphakia Lens for the Correction of Aphakia in Children
Official title: Artisan Aphakia Lens for the Correction of Aphakia in Children
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Aphakia
Keywords: aphakia
secondary intraocular lens
congenital cataract
marfan syndrome
pediatric cataract
ectopia lentis
subluxated lens
Lead sponsor: Ophtec USA
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Best corrected distance visual acuity at 12 months postoperative
timeFrame: 5 years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: The Vision Center
state: California
city: Indianapolis
country: United States
facility: Indiana University, Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Harvard University, Boston Children's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota, MN Lions Children's Eye Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital and Clinics
state: Missouri
city: Saint Louis
country: United States
facility: Washington University, St. Louis Children's Hospital
state: Missouri
city: Great Neck
country: United States
facility: Rosenthal Eye and Facial Plastic Surgery
state: New York
city: Valhalla
country: United States
facility: New York Medical College, Westchester Medical Center
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital, Pediatric Ophthalmology Associates
state: Ohio
city: Mayfield Heights
country: United States
facility: University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Storm Eye Institute
state: South Carolina
city: Dallas
country: United States
facility: University of Texas, Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas, Robert Cizik Eye Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Moran Eye Center
state: Utah
city: Mississauga
country: Canada
facility: Credit Valley Eyecare
state: Ontario
Study officials:
affiliation: Sponsor GmbH
name: Abraham Farhan
role: STUDY_DIRECTOR
References: