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

NCT ID: NCT01547429

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Not desired

Conditions

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Aphakia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Artisan Aphakia Intraocular Lens

Intervention Type DEVICE

Implantation of lens to correct refractive error in aphakic eye

Interventions

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Artisan Aphakia Intraocular Lens

Implantation of lens to correct refractive error in aphakic eye

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ophtec USA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abraham Farhan

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Assil Eye Institute

Beverly Hills, California, United States

Site Status

Advanced Vision Care

Los Angeles, California, United States

Site Status

Yale Medicine Ophthalmology

Stratford, Connecticut, United States

Site Status

UF Health Eye Center

Gainesville, Florida, United States

Site Status

Price Vision Group

Indianapolis, Indiana, United States

Site Status

John Kenyon Eye Center

Jeffersonville, Indiana, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Rosenthal Eye and Facial Plastic Surgery

Great Neck, New York, United States

Site Status

Pamel Vision and Laser Group

New York, New York, United States

Site Status

Sight MD

Rockville Centre, New York, United States

Site Status

New York Medical College, Westchester Medical Center

Valhalla, New York, United States

Site Status

Nevyas Eye Associates

Bala-Cynwyd, Pennsylvania, United States

Site Status

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

University of Tennessee, Hamilton Eye Clinic

Memphis, Tennessee, United States

Site Status

Focal Point Vision

San Antonio, Texas, United States

Site Status

Moran Eye Center

Salt Lake City, Utah, United States

Site Status

Valley Eye Associates

Appleton, Wisconsin, United States

Site Status

Prism Eye Institute

Mississauga, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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Artisan Adult Aphakia

Identifier Type: -

Identifier Source: org_study_id

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