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SuspendedNCT01547429Updated Aug 7, 2024

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

An interventional study of Artisan Aphakia Intraocular Lens in Aphakia, sponsored by Ophtec USA. Suspended at 18 sites in 2 countries. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Ophtec USA · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

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.

Read the detailed description

Not desired

02

Conditions studied

  • Aphakia

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Keywords

  • aphakia
  • secondary intraocular lens
03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's planned enrollment of 300 is above the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Ophtec USA is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceArtisan Aphakia Intraocular Lens

    Implantation of lens to correct refractive error in aphakic eye

06

What researchers measure

Primary outcomes

  1. Improvement in best corrected visual acuity

    Time frame: 3 year follow up

07

Study locations

18 sites
  • Assil Eye Institute
    Beverly Hills, California 90210, United States
  • Advanced Vision Care
    Los Angeles, California 90067, United States
  • Yale Medicine Ophthalmology
    Stratford, Connecticut 06614, United States
  • UF Health Eye Center
    Gainesville, Florida 32605, United States
  • Price Vision Group
    Indianapolis, Indiana 46260, United States
  • John Kenyon Eye Center
    Jeffersonville, Indiana 47130, United States
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
  • Rosenthal Eye and Facial Plastic Surgery
    Great Neck, New York 11023, United States
  • Pamel Vision and Laser Group
    New York, New York 10065, United States
  • Sight MD
    Rockville Centre, New York 11570, United States
  • New York Medical College, Westchester Medical Center
    Valhalla, New York 10595, United States
  • Nevyas Eye Associates
    Bala-Cynwyd, Pennsylvania 19004, United States
  • Vance Thompson Vision
    Sioux Falls, South Dakota 57108, United States
  • University of Tennessee, Hamilton Eye Clinic
    Memphis, Tennessee 38163, United States
  • Focal Point Vision
    San Antonio, Texas 78229, United States
  • Moran Eye Center
    Salt Lake City, Utah 84132, United States
  • Valley Eye Associates
    Appleton, Wisconsin 54914, United States
  • Prism Eye Institute
    Mississauga, Ontario L5L 1W8, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Dec 2025 and a completion of Dec 2025. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2012
First posted
Mar 7, 2012
Start
Jan 2012
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Aug 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01547429
Lead sponsor
Ophtec USA
Responsible party
Sponsor
First posted
Mar 7, 2012
Start date
Jan 2012
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 7, 2024

Study contacts

Abraham Farhan
study director · Sponsor GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Ophtec USA

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