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

Last updated: August 5, 2024
Sponsor: Ophtec USA
Overall Status: Suspended

Phase

N/A

Condition

N/A

Treatment

Artisan Aphakia Intraocular Lens

Clinical Study ID

NCT01547429
Artisan Adult Aphakia
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 22 years of age and over at baseline visit of either sex and of any racewhere the natural lens has been removed or will be removed and a posterior chamberIOL is not indicated.

  • Patient must agree to comply with the visit schedule and other requirements of thestudy

Exclusion

Exclusion Criteria:

  • Patients that are not able to meet the extensive postoperative evaluationrequirements

  • 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 asaniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or othercompromising 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 benefitor 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 retinopathyof prematurity or Stargardt's retinopathy Optic nerve disease that may limit thevisual potential of the eye

  • Diabetes mellitus

  • Pregnant, lactating, or plans to become pregnant during the course of this study

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Artisan Aphakia Intraocular Lens
Phase:
Study Start date:
January 01, 2012
Estimated Completion Date:
December 31, 2025

Study Description

Not desired

Connect with a study center

  • Prism Eye Institute

    Mississauga, Ontario L5L 1W8
    Canada

    Site Not Available

  • Assil Eye Institute

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Advanced Vision Care

    Los Angeles, California 90067
    United States

    Site Not Available

  • Yale Medicine Ophthalmology

    Stratford, Connecticut 06614
    United States

    Site Not Available

  • Ophtec Usa

    Boca Raton, Florida 33487
    United States

    Site Not Available

  • UF Health Eye Center

    Gainesville, Florida 32605
    United States

    Site Not Available

  • Price Vision Group

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • John Kenyon Eye Center

    Jeffersonville, Indiana 47130
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Rosenthal Eye and Facial Plastic Surgery

    Great Neck, New York 11023
    United States

    Site Not Available

  • Pamel Vision and Laser Group

    New York, New York 10065
    United States

    Site Not Available

  • Sight MD

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • New York Medical College, Westchester Medical Center

    Valhalla, New York 10595
    United States

    Site Not Available

  • Nevyas Eye Associates

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Vance Thompson Vision

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • University of Tennessee, Hamilton Eye Clinic

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Focal Point Vision

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Moran Eye Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Valley Eye Associates

    Appleton, Wisconsin 54914
    United States

    Site Not Available

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