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

Aphakia Clinical Trial

Official title:

Artisan Aphakia Lens for the Correction of Aphakia in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01547429
• Other study ID #: Artisan Adult Aphakia
• Status: Recruiting
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2025

Study information

• Verified date: June 2022
• Source: Ophtec USA
• Contact: Abraham Farahan
• Phone: 561-989-8767
• Email: abraham.farhan[@]usa.ophtec.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not desired

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• Artisan Aphakia Intraocular Lens
Implantation of lens to correct refractive error in aphakic eye

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ophtec USA

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in best corrected visual acuity		3 year follow up