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

June 24, 2022 updated by: Ophtec USA

Artisan Aphakia Lens for the Correction of Aphakia in Adults

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Not desired

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5L 1W8
        • Recruiting
        • Prism Eye Institute
  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • Assil Eye Institute
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Advanced Vision Care
    • Connecticut
      • Stratford, Connecticut, United States, 06614
        • Active, not recruiting
        • Yale Medicine Ophthalmology
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Price Vision Group
      • Jeffersonville, Indiana, United States, 47130
        • Recruiting
        • John Kenyon Eye Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
    • New York
      • Great Neck, New York, United States, 11023
        • Suspended
        • Rosenthal Eye and Facial Plastic Surgery
      • New York, New York, United States, 10065
        • Suspended
        • Pamel Vision and Laser Group
      • Valhalla, New York, United States, 10595
        • Recruiting
        • New York Medical College, Westchester Medical Center
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • Nevyas Eye Associates
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Vance Thompson Vision
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Recruiting
        • University of Tennessee, Hamilton Eye Clinic
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Focal Point Vision
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • Moran Eye Center
    • Wisconsin
      • Appleton, Wisconsin, United States, 54914
        • Recruiting
        • Valley Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in best corrected visual acuity
Time Frame: 3 year follow up
3 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophtec USA

Investigators

  • Study Director: Abraham Farhan, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Artisan Adult Aphakia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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