Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults
- Conditions
- Aphakia
- Interventions
- Device: Artisan Aphakia Intraocular Lens
- Registration Number
- NCT01547429
- Lead Sponsor
- Ophtec USA
- 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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intraocular Lens Implantation for the Treatment for Aphakia Artisan Aphakia Intraocular Lens Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section
- Primary Outcome Measures
Name Time Method Improvement in best corrected visual acuity 3 year follow up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
UF Health Eye Center
🇺🇸Gainesville, Florida, United States
Focal Point Vision
🇺🇸San Antonio, Texas, United States
Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
Price Vision Group
🇺🇸Indianapolis, Indiana, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
New York Medical College, Westchester Medical Center
🇺🇸Valhalla, New York, United States
Valley Eye Associates
🇺🇸Appleton, Wisconsin, United States
Advanced Vision Care
🇺🇸Los Angeles, California, United States
Assil Eye Institute
🇺🇸Beverly Hills, California, United States
Yale Medicine Ophthalmology
🇺🇸Stratford, Connecticut, United States
John Kenyon Eye Center
🇺🇸Jeffersonville, Indiana, United States
Rosenthal Eye and Facial Plastic Surgery
🇺🇸Great Neck, New York, United States
Sight MD
🇺🇸Rockville Centre, New York, United States
Pamel Vision and Laser Group
🇺🇸New York, New York, United States
Nevyas Eye Associates
🇺🇸Bala-Cynwyd, Pennsylvania, United States
University of Tennessee, Hamilton Eye Clinic
🇺🇸Memphis, Tennessee, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States
Prism Eye Institute
🇨🇦Mississauga, Ontario, Canada