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Artisan Aphakia Lens for the Correction of Aphakia in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01547442
Recruitment Status : Recruiting
First Posted : March 7, 2012
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Ophtec USA

Tracking Information
First Submitted Date  ICMJE February 27, 2012
First Posted Date  ICMJE March 7, 2012
Last Update Posted Date June 27, 2022
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)		 Best corrected distance visual acuity at 12 months postoperative [ Time Frame: 5 years follow up ]
Determination of the ability of the lens to correct refractive error caused by aphakia
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2012)		 Uncorrected visual acuity at 1 year postoperative [ Time Frame: 5 years follow up ]
Determination of the ability of the lens to correct refractive error caused by aphakia
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Artisan Aphakia Lens for the Correction 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  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aphakia
Intervention  ICMJE Device: Artisan Aphakia Intraocular Lens
Implantation of an intraocular lens
Study Arms  ICMJE Experimental: Artisan Aphakia Intraocular Lens
Implantation of an Artisan intraocular lens to correct 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
 (submitted: March 2, 2012)		 300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (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 3.2 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Abraham Farhan 561-989-8767 abraham.farhan@usa.ophtec.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547442
Other Study ID Numbers  ICMJE Artisan Pediatric Aphakia
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ophtec USA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ophtec USA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Abraham Farhan Sponsor GmbH
PRS Account Ophtec USA
Verification Date June 2022

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