NCT01547429

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.

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

18 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

13.9 years

First QC Date

February 27, 2012

Last Update Submit

August 5, 2024

Conditions

Aphakia

Keywords

aphakiasecondary intraocular lens

Outcome Measures

Primary Outcomes (1)

  • Improvement in best corrected visual acuity

    3 year follow up

Study Arms (1)

Intraocular Lens Implantation for the Treatment for Aphakia

EXPERIMENTAL

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

Interventions

Artisan Aphakia Intraocular LensDEVICE

Implantation of lens to correct refractive error in aphakic eye

Intraocular Lens Implantation for the Treatment for Aphakia

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Assil Eye Institute

Beverly Hills, California, 90210, United States

Location

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

Yale Medicine Ophthalmology

Stratford, Connecticut, 06614, United States

Location

UF Health Eye Center

Gainesville, Florida, 32605, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

John Kenyon Eye Center

Jeffersonville, Indiana, 47130, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Rosenthal Eye and Facial Plastic Surgery

Great Neck, New York, 11023, United States

Location

Pamel Vision and Laser Group

New York, New York, 10065, United States

Location

Sight MD

Rockville Centre, New York, 11570, United States

Location

New York Medical College, Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Nevyas Eye Associates

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

University of Tennessee, Hamilton Eye Clinic

Memphis, Tennessee, 38163, United States

Location

Focal Point Vision

San Antonio, Texas, 78229, United States

Location

Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

Valley Eye Associates

Appleton, Wisconsin, 54914, United States

Location

Prism Eye Institute

Mississauga, Ontario, L5L 1W8, Canada

Location

MeSH Terms

Conditions

Aphakia

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Abraham Farhan

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 7, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations

CA(1)US(17)