search
Back to results

Artisan Aphakia Lens for the Correction of Aphakia in Children

Primary Purpose

Aphakia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Artisan Aphakia Intraocular Lens
Sponsored by
Ophtec USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia focused on measuring aphakia, secondary intraocular lens, congenital cataract, marfan syndrome, pediatric cataract, ectopia lentis, subluxated lens

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Vision CenterRecruiting
  • Indiana University, Riley Hospital for ChildrenRecruiting
  • Johns Hopkins Wilmer Eye Institute
  • Harvard University, Boston Children's HospitalRecruiting
  • University of Minnesota, MN Lions Children's Eye ClinicRecruiting
  • Mayo ClinicRecruiting
  • Children's Mercy Hospital and Clinics
  • Washington University, St. Louis Children's HospitalRecruiting
  • Rosenthal Eye and Facial Plastic Surgery
  • New York Medical College, Westchester Medical CenterRecruiting
  • Nationwide Children's Hospital, Pediatric Ophthalmology AssociatesRecruiting
  • University Hospitals Case Medical Center, Rainbow Babies and Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • University of Pittsburgh Medical Center, Children's Hospital of PittsburghRecruiting
  • Medical University of South Carolina, Storm Eye InstituteRecruiting
  • University of Texas, Southwestern Medical CenterRecruiting
  • University of Texas, Robert Cizik Eye ClinicRecruiting
  • Moran Eye CenterRecruiting
  • UW-Madison
  • Credit Valley EyecareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artisan Aphakia Intraocular Lens

Arm Description

Implantation of an Artisan intraocular lens to correct aphakia in children

Outcomes

Primary Outcome Measures

Best corrected distance visual acuity at 12 months postoperative
Determination of the ability of the lens to correct refractive error caused by aphakia

Secondary Outcome Measures

Full Information

First Posted
February 27, 2012
Last Updated
June 24, 2022
Sponsor
Ophtec USA
search

1. Study Identification

Unique Protocol Identification Number
NCT01547442
Brief Title
Artisan Aphakia Lens for the Correction of Aphakia in Children
Official Title
Artisan Aphakia Lens for the Correction of Aphakia in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophtec USA

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia
Keywords
aphakia, secondary intraocular lens, congenital cataract, marfan syndrome, pediatric cataract, ectopia lentis, subluxated lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artisan Aphakia Intraocular Lens
Arm Type
Experimental
Arm Description
Implantation of an Artisan intraocular lens to correct aphakia in children
Intervention Type
Device
Intervention Name(s)
Artisan Aphakia Intraocular Lens
Intervention Description
Implantation of an intraocular lens
Primary Outcome Measure Information:
Title
Best corrected distance visual acuity at 12 months postoperative
Description
Determination of the ability of the lens to correct refractive error caused by aphakia
Time Frame
5 years follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 3.2 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abraham Farhan
Phone
561-989-8767
Email
abraham.farhan@usa.ophtec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Farhan
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
The Vision Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University, Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Individual Site Status
Withdrawn
Facility Name
Harvard University, Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Minnesota, MN Lions Children's Eye Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Mercy Hospital and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Completed
Facility Name
Washington University, St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Rosenthal Eye and Facial Plastic Surgery
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Individual Site Status
Suspended
Facility Name
New York Medical College, Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Name
Nationwide Children's Hospital, Pediatric Ophthalmology Associates
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina, Storm Eye Institute
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas, Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas, Robert Cizik Eye Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
UW-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Withdrawn
Facility Name
Credit Valley Eyecare
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L 1W8
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Artisan Aphakia Lens for the Correction of Aphakia in Children

We'll reach out to this number within 24 hrs