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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ophtec USA
Sponsor:
Information provided by (Responsible Party):
Ophtec USA
ClinicalTrials.gov Identifier:
NCT01547429
First received: February 27, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.


Condition Intervention Phase
Aphakia
Device: Artisan Aphakia Intraocular Lens
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Artisan Aphakia Lens for the Correction of Aphakia in Adults

Further study details as provided by Ophtec USA:

Primary Outcome Measures:
  • Improvement in uncorrected visual acuity [ Time Frame: 3 year follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: Artisan Aphakia Intraocular Lens
Implantation of lens to correct refractive error in aphakic eye

Detailed Description:

Not desired

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547429

Contacts
Contact: Rick McCarley 561-989-8767 rick.mccarley@usa.ophtec.com

Locations
United States, Florida
Ophtec Usa Recruiting
Boca Raton, Florida, United States, 33487
Contact: Jean Pak, MBS    561-989-8767    jean.pak@usa.ophtec.com   
Principal Investigator: Gregory Pamel, MD         
Sponsors and Collaborators
Ophtec USA
Investigators
Study Director: Rick McCarley Sponsor GmbH
  More Information

No publications provided

Responsible Party: Ophtec USA
ClinicalTrials.gov Identifier: NCT01547429     History of Changes
Other Study ID Numbers: Artisan Adult Aphakia
Study First Received: February 27, 2012
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ophtec USA:
aphakia secondary len implants IOLs

Additional relevant MeSH terms:
Aphakia
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014