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Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults

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: NCT01547429
Recruitment Status : Recruiting
First Posted : March 7, 2012
Last Update Posted : February 2, 2016
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 February 2, 2016
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
Improvement in best corrected visual acuity [ Time Frame: 3 year follow up ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2012)
Improvement in uncorrected visual acuity [ Time Frame: 3 year follow up ]
Change History Complete list of historical versions of study NCT01547429 on ClinicalTrials.gov Archive Site
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 (Secondary) in Adults
Official Title  ICMJE Artisan Aphakia Lens for the Correction of Aphakia in Adults
Brief Summary This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.
Detailed Description Not desired
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aphakia
Intervention  ICMJE Device: Artisan Aphakia Intraocular Lens
Implantation of lens to correct refractive error in aphakic eye
Study Arms  ICMJE Experimental: Intraocular Lens Implantation for the Treatment for Aphakia
Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section
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 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
  • Patient must agree to comply with the visit schedule and other requirements of the study

Exclusion Criteria:

  • Patients that are not able to meet the extensive postoperative evaluation requirements
  • Mentally retarded patients
  • When the patient has no useful vision or vision potential in the fellow eye
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
  • Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
  • Patients with uncontrolled glaucoma
  • High preoperative intraocular pressure, >25 mmHg
  • Chronic or recurrent uveitis or history of the same
  • Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
  • Patients with a retinal detachment or a family history of retinal detachment
  • Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye
  • Diabetes mellitus
  • Pregnant, lactating, or plans to become pregnant during the course of this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Fred Wassenburg 561-989-8767 f.wassenburg@ophtec.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547429
Other Study ID Numbers  ICMJE Artisan Adult Aphakia
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ophtec USA
Study Sponsor  ICMJE Ophtec USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fred Wassenburg Sponsor GmbH
PRS Account Ophtec USA
Verification Date January 2016

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