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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01547429
Recruitment Status : Recruiting
First Posted : March 7, 2012
Last Update Posted : August 6, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aphakia Device: Artisan Aphakia Intraocular Lens Phase 3

Detailed Description:
Not desired

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artisan Aphakia Lens for the Correction of Aphakia in Adults
Study Start Date : January 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement in best corrected visual acuity [ Time Frame: 3 year follow up ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01547429

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Contact: Fred Wassenburg 561-989-8767

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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, Connecticut
Yale Medicine Ophthalmology Active, not recruiting
Stratford, Connecticut, United States, 06614
United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
John Kenyon Eye Center Recruiting
Jeffersonville, Indiana, United States, 47130
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
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, Pennsylvania
Nevyas Eye Associates Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
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
United States, Wisconsin
Valley Eye Associates Recruiting
Appleton, Wisconsin, United States, 54914
Canada, Ontario
Prism Eye Institute Recruiting
Mississauga, Ontario, Canada, L5L 1W8
Sponsors and Collaborators
Ophtec USA
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Study Director: Fred Wassenburg Sponsor GmbH
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Responsible Party: Ophtec USA Identifier: NCT01547429    
Other Study ID Numbers: Artisan Adult Aphakia
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Keywords provided by Ophtec USA:
secondary intraocular lens
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases