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

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Conditions studied: Aphakia

In brief

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

Key facts

Study ID

NCT01547429

Run by

Ophtec USA

People needed

300

Starts

2012-01-01

Expected to finish

2025-12-01

Last updated by the study team

2024-08-07

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Assil Eye Institute — Beverly Hills, California, United States
• Advanced Vision Care — Los Angeles, California, United States
• Yale Medicine Ophthalmology — Stratford, Connecticut, United States
• UF Health Eye Center — Gainesville, Florida, United States
• Price Vision Group — Indianapolis, Indiana, United States
• John Kenyon Eye Center — Jeffersonville, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Rosenthal Eye and Facial Plastic Surgery — Great Neck, New York, United States
• Pamel Vision and Laser Group — New York, New York, United States
• Sight MD — Rockville Centre, New York, United States
• New York Medical College, Westchester Medical Center — Valhalla, New York, United States
• Nevyas Eye Associates — Bala-Cynwyd, Pennsylvania, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States
• University of Tennessee, Hamilton Eye Clinic — Memphis, Tennessee, United States
• Focal Point Vision — San Antonio, Texas, United States
• Moran Eye Center — Salt Lake City, Utah, United States
• Valley Eye Associates — Appleton, Wisconsin, United States
• Prism Eye Institute — Mississauga, Ontario, Canada

Full record on ClinicalTrials.gov

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