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Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

Sponsor
Lenstec Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00963742
Collaborator
(none)
390
Enrollment
1
Arm
40
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Lenstec Softec HD IOL implantation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
390 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Distance Best Corrected Visual Acuity [1 year]

    Secondary Outcome Measures

    1. FDA IOL Grid Adverse Events [through 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lenstec Incorporated

    Investigators

    • Study Director: Donald R Sanders, M.D. Ph.D, Center for Clinical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lenstec Incorporated
    ClinicalTrials.gov Identifier:
    NCT00963742
    Other Study ID Numbers:
    • IDE G060058
    First Posted:
    Aug 21, 2009
    Last Update Posted:
    Mar 18, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Lenstec Incorporated
    cataract surgery
    IOL
    Intraocular lens
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Mar 18, 2014