Clinical trial NCT01547429: Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults
Official title: Artisan Aphakia Lens for the Correction of Aphakia in Adults
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Aphakia
Keywords: aphakia
secondary intraocular lens
Lead sponsor: Ophtec USA
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.

Detailed description: Not desired

Eligibility criteria: Inclusion Criteria:

* Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
* Patient must agree to comply with the visit schedule and other requirements of the study

Exclusion Criteria:

* Patients that are not able to meet the extensive postoperative evaluation requirements
* Mentally retarded patients
* When the patient has no useful vision or vision potential in the fellow eye
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
* Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
* Patients with uncontrolled glaucoma
* High preoperative intraocular pressure, \>25 mmHg
* Chronic or recurrent uveitis or history of the same
* Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
* Patients with a retinal detachment or a family history of retinal detachment
* Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye
* Diabetes mellitus
* Pregnant, lactating, or plans to become pregnant during the course of this study

Primary outcomes:
measure: Improvement in best corrected visual acuity
timeFrame: 3 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Assil Eye Institute
state: California
city: Los Angeles
country: United States
facility: Advanced Vision Care
state: California
city: Stratford
country: United States
facility: Yale Medicine Ophthalmology
state: Connecticut
city: Gainesville
country: United States
facility: UF Health Eye Center
state: Florida
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Jeffersonville
country: United States
facility: John Kenyon Eye Center
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Great Neck
country: United States
facility: Rosenthal Eye and Facial Plastic Surgery
state: New York
city: New York
country: United States
facility: Pamel Vision and Laser Group
state: New York
city: Rockville Centre
country: United States
facility: Sight MD
state: New York
city: Valhalla
country: United States
facility: New York Medical College, Westchester Medical Center
state: New York
city: Bala-Cynwyd
country: United States
facility: Nevyas Eye Associates
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Memphis
country: United States
facility: University of Tennessee, Hamilton Eye Clinic
state: Tennessee
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: Salt Lake City
country: United States
facility: Moran Eye Center
state: Utah
city: Appleton
country: United States
facility: Valley Eye Associates
state: Wisconsin
city: Mississauga
country: Canada
facility: Prism Eye Institute
state: Ontario
Study officials:
affiliation: Sponsor GmbH
name: Abraham Farhan
role: STUDY_DIRECTOR
References: