Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lenstec Incorporated
ClinicalTrials.gov Identifier:
NCT00963742
First received: August 20, 2009
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.


Condition Intervention
Cataract
Device: Lenstec Softec HD IOL implantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol

Resource links provided by NLM:


Further study details as provided by Lenstec Incorporated:

Primary Outcome Measures:
  • Distance Best Corrected Visual Acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FDA IOL Grid Adverse Events [ Time Frame: through 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 390
Study Start Date: December 2006
Study Completion Date: April 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenstec Softec HD IOL implantation
390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract
Device: Lenstec Softec HD IOL implantation
surgical removal of cataract and implantation of Softec HD PCIOL
Other Names:
  • Softec HD PCIOL
  • Softec HD Posterior Chamber IOL
  • Softec HD Posterior Chamber Intraocular Lens

Detailed Description:

The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cataract requiring cataract extraction
  • Study IOL to only be implanted in 1 eye
  • Distance BCVA 20/40 or worse or glare acuity worse than 20/30
  • Ability to comply with study follow-up requirements

Exclusion Criteria:

  • Patients with serious corneal disease, previous surgery or serious systemic disease
  • Ocular condition that could impact vision after cataract surgery
  • Pregnant or lactating women
  • Use of ocular or systemic medications that could impact vision
  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: NCT00963742

Sponsors and Collaborators
Lenstec Incorporated
Investigators
Study Director: Donald R Sanders, M.D. Ph.D Center for Clinical Research
  More Information

No publications provided

Responsible Party: Lenstec Incorporated
ClinicalTrials.gov Identifier: NCT00963742     History of Changes
Other Study ID Numbers: IDE G060058
Study First Received: August 20, 2009
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lenstec Incorporated:
cataract surgery
IOL
Intraocular lens

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 25, 2014