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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Ophtec USA
Sponsor:
Information provided by (Responsible Party):
Ophtec USA
ClinicalTrials.gov Identifier:
NCT01547429
First received: February 27, 2012
Last updated: January 31, 2016
Last verified: January 2016
  Purpose
This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.

Condition Intervention Phase
Aphakia
Device: Artisan Aphakia Intraocular Lens
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Artisan Aphakia Lens for the Correction of Aphakia in Adults

Further study details as provided by Ophtec USA:

Primary Outcome Measures:
  • Improvement in best corrected visual acuity [ Time Frame: 3 year follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraocular Lens Implantation for the Treatment for Aphakia
Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section
Device: Artisan Aphakia Intraocular Lens
Implantation of lens to correct refractive error in aphakic eye

Detailed Description:
Not desired
  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547429

Contacts
Contact: Fred Wassenburg 561-989-8767 f.wassenburg@ophtec.com

Locations
United States, California
Assil Eye Institute Recruiting
Beverly Hills, California, United States, 90210
Advanced Vision Care Recruiting
Los Angeles, California, United States, 90067
United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
John Kenyon Eye Center Recruiting
Jeffersonville, Indiana, United States, 47130
United States, New York
Rosenthal Eye and Facial Plastic Surgery Recruiting
Great Neck, New York, United States, 11023
Pamel Vision and Laser Group Recruiting
New York, New York, United States, 10065
New York Medical College, Westchester Medical Center Recruiting
Valhalla, New York, United States, 10595
United States, South Dakota
Vance Thompson Vision Recruiting
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
University of Tennessee, Hamilton Eye Clinic Recruiting
Memphis, Tennessee, United States, 38163
United States, Texas
Focal Point Vision Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Moran Eye Center Recruiting
Salt Lake City, Utah, United States, 84132
Canada, Ontario
Credit Valley Eyecare Recruiting
Mississauga, Ontario, Canada, L5L 1W8
Sponsors and Collaborators
Ophtec USA
Investigators
Study Director: Fred Wassenburg Sponsor GmbH
  More Information

Responsible Party: Ophtec USA
ClinicalTrials.gov Identifier: NCT01547429     History of Changes
Other Study ID Numbers: Artisan Adult Aphakia 
Study First Received: February 27, 2012
Last Updated: January 31, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Ophtec USA:
aphakia
secondary intraocular lens

Additional relevant MeSH terms:
Aphakia
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 01, 2016