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

Purpose

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

Condition	Intervention	Phase
Aphakia	Device: Artisan Aphakia Intraocular Lens	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Artisan Aphakia Lens for the Correction of Aphakia in Children

Further study details as provided by Ophtec USA:

Primary Outcome Measures:

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

Estimated Enrollment:	300
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2021
Estimated Primary Completion Date:	December 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment for Aphakia Implantation of an Artisan intraocular lens to correct of aphakia in children	Device: Artisan Aphakia Intraocular Lens Implantation of an intraocular lens

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547442

Locations

United States, Florida
Ophtec Usa	Recruiting
Boca Raton, Florida, United States, 33487
Contact: Jean Pak, MBS 561-989-8767 jean.pak@usa.ophtec.com
Principal Investigator: Lawrence Tychsen, MD

Sponsors and Collaborators

Ophtec USA

Investigators

Study Director:

Rick McCarley

Sponsor GmbH

More Information

No publications provided

Responsible Party:	Ophtec USA
ClinicalTrials.gov Identifier:	NCT01547442 History of Changes
Other Study ID Numbers:	Artisan Pediatric Aphakia
Study First Received:	February 27, 2012
Last Updated:	August 8, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ophtec USA:

aphakia IOL secondary IOL pediatriac cataract

Additional relevant MeSH terms:

Aphakia
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013