Artisan Aphakia Lens for the Treatment of Aphakia in Children

This study is currently recruiting participants.

Verified August 2012 by Ophtec USA

Sponsor:

Information provided by (Responsible Party):

Ophtec USA

ClinicalTrials.gov Identifier:

NCT01547442

First received: February 27, 2012

Last updated: August 8, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2012

Last Updated Date

August 8, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2020 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Uncorrected visual acuity at 1 year postoperative [ Time Frame: 5 years follow up ] [ Designated as safety issue: Yes ]

Determination of the ability of the lens to correct refractive error caused by aphakia

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01547442 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Artisan Aphakia Lens for the Treatment of Aphakia in Children

Official Title ^ICMJE

Artisan Aphakia Lens for the Correction of Aphakia in Children

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Aphakia

Intervention ^ICMJE

Device: Artisan Aphakia Intraocular Lens

Implantation of an intraocular lens

Study Arm (s)

Experimental: Treatment for Aphakia

Implantation of an Artisan intraocular lens to correct of aphakia in children

Intervention: Device: Artisan Aphakia Intraocular Lens

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2021

Estimated Primary Completion Date

December 2020 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

2 to 21 years of age
Have a visually significant cataract or need IOL replacement surgery
Compromised capsular bag prohibiting implantation of standard posterior IOL
Subject or parent/guardian must be able to comply with visit schedule and study requirements
Subject's legal representative must be able to sign the Informed Consent

Exclusion Criteria:

Under 2 years of age
Unable to meet Postoperative evaluation requirements
No useful vision or vision potential in fellow eye
Mentally retarded patients
History of corneal disease
Abnormality of the iris or ocular structure
ACD less than 3.2mm
Uncontrolled glaucoma
IOP > 25mm Hg
Chronic or recurrent uveitis
Preexisting macular pathology that may complicate the ability to assess the benefit of this lens
Retinal detachment or family history
Retinal disease that may limit visual potential
Optic nerve disease that may limit visual potential
Diabetes mellitus
Pregnant, lactating or plan to become pregnant

Gender

Both

Ages

2 Years to 21 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01547442

Other Study ID Numbers ^ICMJE

Artisan Pediatric Aphakia

Has Data Monitoring Committee

Responsible Party

Ophtec USA

Study Sponsor ^ICMJE

Ophtec USA

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Rick McCarley

Sponsor GmbH

Information Provided By

Ophtec USA

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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