Artisan Aphakia Lens for the Correction of Aphakia in Children

Sponsor

Ophtec USA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT01547442

Collaborator

(none)

300

Enrollment

Locations

Arm

167

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aphakia	Device: Artisan Aphakia Intraocular Lens	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Artisan Aphakia Lens for the Correction of Aphakia in Children

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artisan Aphakia Intraocular Lens Implantation of an Artisan intraocular lens to correct aphakia in children	Device: Artisan Aphakia Intraocular Lens Implantation of an intraocular lens

Arm

Intervention/Treatment

Experimental: Artisan Aphakia Intraocular Lens

Implantation of an Artisan intraocular lens to correct aphakia in children

Device: Artisan Aphakia Intraocular Lens

Implantation of an intraocular lens

Outcome Measures

Primary Outcome Measures

Best corrected distance visual acuity at 12 months postoperative [5 years follow up]
Determination of the ability of the lens to correct refractive error caused by aphakia

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 3.2 mm
Uncontrolled glaucoma
IOP > 25 mmHg
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

Locations

	Site	City	State	Country	Postal Code
1	The Vision Center	Los Angeles	California	United States	90027
2	Indiana University, Riley Hospital for Children	Indianapolis	Indiana	United States	46202
3	Johns Hopkins Wilmer Eye Institute	Baltimore	Maryland	United States	20814
4	Harvard University, Boston Children's Hospital	Boston	Massachusetts	United States	02115
5	University of Minnesota, MN Lions Children's Eye Clinic	Minneapolis	Minnesota	United States	55454
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	Children's Mercy Hospital and Clinics	Kansas City	Missouri	United States	64111
8	Washington University, St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
9	Rosenthal Eye and Facial Plastic Surgery	Great Neck	New York	United States	11023
10	New York Medical College, Westchester Medical Center	Valhalla	New York	United States	10595
11	Nationwide Children's Hospital, Pediatric Ophthalmology Associates	Columbus	Ohio	United States	43205
12	University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital	Mayfield Heights	Ohio	United States	44124
13	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
14	University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224
15	Medical University of South Carolina, Storm Eye Institute	Charleston	South Carolina	United States	29425
16	University of Texas, Southwestern Medical Center	Dallas	Texas	United States	75390
17	University of Texas, Robert Cizik Eye Clinic	Houston	Texas	United States	77030
18	Moran Eye Center	Salt Lake City	Utah	United States	84132
19	UW-Madison	Madison	Wisconsin	United States	53705
20	Credit Valley Eyecare	Mississauga	Ontario	Canada	L5L 1W8