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
20
Locations
1
Arm
131
Duration (Months)
15
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 DiseaseIntervention/TreatmentPhase
  • 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, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/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

  1. 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

SiteCityStateCountryPostal Code
1The Vision CenterLos AngelesCaliforniaUnited States90027
2Indiana University, Riley Hospital for ChildrenIndianapolisIndianaUnited States46202
3Johns Hopkins Wilmer Eye InstituteBaltimoreMarylandUnited States20814
4Harvard University, Boston Children's HospitalBostonMassachusettsUnited States02115
5University of Minnesota, MN Lions Children's Eye ClinicMinneapolisMinnesotaUnited States55454
6Mayo ClinicRochesterMinnesotaUnited States55905
7Children's Mercy Hospital and ClinicsKansas CityMissouriUnited States64111
8Washington University, St. Louis Children's HospitalSaint LouisMissouriUnited States63110
9Rosenthal Eye and Facial Plastic SurgeryGreat NeckNew YorkUnited States11023
10New York Medical College, Westchester Medical CenterValhallaNew YorkUnited States10595
11Nationwide Children's Hospital, Pediatric Ophthalmology AssociatesColumbusOhioUnited States43205
12University Hospitals Case Medical Center, Rainbow Babies and Children's HospitalMayfield HeightsOhioUnited States44124
13Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States19104
14University of Pittsburgh Medical Center, Children's Hospital of PittsburghPittsburghPennsylvaniaUnited States15224
15Medical University of South Carolina, Storm Eye InstituteCharlestonSouth CarolinaUnited States29425
16University of Texas, Southwestern Medical CenterDallasTexasUnited States75390
17University of Texas, Robert Cizik Eye ClinicHoustonTexasUnited States77030
18Moran Eye CenterSalt Lake CityUtahUnited States84132
19UW-MadisonMadisonWisconsinUnited States53705
20Credit Valley EyecareMississaugaOntarioCanadaL5L 1W8

Sponsors and Collaborators

  • Ophtec USA

Investigators

  • Study Director: Fred Wassenburg, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ophtec USA
ClinicalTrials.gov Identifier:
NCT01547442
Other Study ID Numbers:
  • Artisan Pediatric Aphakia
First Posted:
Mar 7, 2012
Last Update Posted:
Feb 23, 2021
Last Verified:
Aug 1, 2020

Study Results

No Results Posted as of Feb 23, 2021