Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults

Description

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

Study Start Date

January 2012

Estimated Completion Date

December 2021

Interventions

  • Device: Artisan Aphakia Intraocular Lens

Specialties

  • Ophthalmology: Lens and Cataract,Optics/Refraction/Lenses,Refractive/Eye Surgery
  • Physician Assistant: Ophthalmology

MeSH Terms

  • Aphakia
  • Artisan Aphakia

Study ID

Ophtec USA -- Artisan Adult Aphakia

Status

Recruiting

Trial ID

NCT01547429

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

300

Sponsor

Ophtec USA

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

Gender

Both

Ages

22 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (19)

Study Location Distance Name Phone Email
New York Medical College Westchester Medical Center - Valhalla, New York 28.9 miles None None None
New York Medical College Westchester Medical Center - Valhalla, New York 28.9 miles None None None
Rosenthal Eye and Facial Plastic Surgery - Great Neck, New York 38.6 miles None None None
Rosenthal Eye and Facial Plastic Surgery - Great Neck, New York 38.6 miles None None None
Pamel Vision and Laser Group - New York, New York 50.7 miles None None None
Pamel Vision and Laser Group - New York, New York 50.7 miles None None None
Price Vision Group - Indianapolis, Indiana 686.2 miles None None None
John Kenyon Eye Center - Jeffersonville, Indiana 694.0 miles None None None
John Kenyon Eye Center - Jeffersonville, Indiana 694.0 miles None None None
University of Tennessee Hamilton Eye Clinic - Memphis, Tennessee 1,004.0 miles None None None
Vance Thompson Vision - Sioux Falls, South Dakota 1,206.0 miles None None None
Focal Point Vision - San Antonio, Texas 1,635.9 miles None None None
Focal Point Vision - San Antonio, Texas 1,635.9 miles None None None
Moran Eye Center - Salt Lake City, Utah 2,001.2 miles None None None
Moran Eye Center - Salt Lake City, Utah 2,001.2 miles None None None
Assil Eye Institute - Beverly Hills, California 2,496.7 miles None None None
Assil Eye Institute - Beverly Hills, California 2,496.7 miles None None None
Advanced Vision Care - Los Angeles, California 2,497.8 miles None None None
Advanced Vision Care - Los Angeles, California 2,497.8 miles None None None

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