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Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lenstec Softec HD IOL implantation
Sponsored by
Lenstec Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract surgery, IOL, Intraocular lens

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lenstec Softec HD IOL implantation

    Arm Description

    390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract

    Outcomes

    Primary Outcome Measures

    Distance Best Corrected Visual Acuity

    Secondary Outcome Measures

    FDA IOL Grid Adverse Events

    Full Information

    First Posted
    August 20, 2009
    Last Updated
    March 17, 2014
    Sponsor
    Lenstec Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00963742
    Brief Title
    Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol
    Official Title
    Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lenstec Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    cataract surgery, IOL, Intraocular lens

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    390 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lenstec Softec HD IOL implantation
    Arm Type
    Experimental
    Arm Description
    390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract
    Intervention Type
    Device
    Intervention Name(s)
    Lenstec Softec HD IOL implantation
    Other Intervention Name(s)
    Softec HD PCIOL, Softec HD Posterior Chamber IOL, Softec HD Posterior Chamber Intraocular Lens
    Intervention Description
    surgical removal of cataract and implantation of Softec HD PCIOL
    Primary Outcome Measure Information:
    Title
    Distance Best Corrected Visual Acuity
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    FDA IOL Grid Adverse Events
    Time Frame
    through 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donald R Sanders, M.D. Ph.D
    Organizational Affiliation
    Center for Clinical Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

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